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Background of The Study – Examples and Writing Guide

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Background of The Study

Definition:

Background of the study refers to the context, circumstances, and history that led to the research problem or topic being studied. It provides the reader with a comprehensive understanding of the subject matter and the significance of the study.

The background of the study usually includes a discussion of the relevant literature, the gap in knowledge or understanding, and the research questions or hypotheses to be addressed. It also highlights the importance of the research topic and its potential contributions to the field. A well-written background of the study sets the stage for the research and helps the reader to appreciate the need for the study and its potential significance.

How to Write Background of The Study

Here are some steps to help you write the background of the study:

Identify the Research Problem

Start by identifying the research problem you are trying to address. This problem should be significant and relevant to your field of study.

Provide Context

Once you have identified the research problem, provide some context. This could include the historical, social, or political context of the problem.

Review Literature

Conduct a thorough review of the existing literature on the topic. This will help you understand what has been studied and what gaps exist in the current research.

Identify Research Gap

Based on your literature review, identify the gap in knowledge or understanding that your research aims to address. This gap will be the focus of your research question or hypothesis.

State Objectives

Clearly state the objectives of your research . These should be specific, measurable, achievable, relevant, and time-bound (SMART).

Discuss Significance

Explain the significance of your research. This could include its potential impact on theory , practice, policy, or society.

Finally, summarize the key points of the background of the study. This will help the reader understand the research problem, its context, and its significance.

How to Write Background of The Study in Proposal

The background of the study is an essential part of any proposal as it sets the stage for the research project and provides the context and justification for why the research is needed. Here are the steps to write a compelling background of the study in your proposal:

• Identify the problem: Clearly state the research problem or gap in the current knowledge that you intend to address through your research.
• Provide context: Provide a brief overview of the research area and highlight its significance in the field.
• Review literature: Summarize the relevant literature related to the research problem and provide a critical evaluation of the current state of knowledge.
• Identify gaps : Identify the gaps or limitations in the existing literature and explain how your research will contribute to filling these gaps.
• Justify the study : Explain why your research is important and what practical or theoretical contributions it can make to the field.
• Highlight objectives: Clearly state the objectives of the study and how they relate to the research problem.
• Discuss methodology: Provide an overview of the methodology you will use to collect and analyze data, and explain why it is appropriate for the research problem.
• Conclude : Summarize the key points of the background of the study and explain how they support your research proposal.

How to Write Background of The Study In Thesis

The background of the study is a critical component of a thesis as it provides context for the research problem, rationale for conducting the study, and the significance of the research. Here are some steps to help you write a strong background of the study:

• Identify the research problem : Start by identifying the research problem that your thesis is addressing. What is the issue that you are trying to solve or explore? Be specific and concise in your problem statement.
• Review the literature: Conduct a thorough review of the relevant literature on the topic. This should include scholarly articles, books, and other sources that are directly related to your research question.
• I dentify gaps in the literature: After reviewing the literature, identify any gaps in the existing research. What questions remain unanswered? What areas have not been explored? This will help you to establish the need for your research.
• Establish the significance of the research: Clearly state the significance of your research. Why is it important to address this research problem? What are the potential implications of your research? How will it contribute to the field?
• Provide an overview of the research design: Provide an overview of the research design and methodology that you will be using in your study. This should include a brief explanation of the research approach, data collection methods, and data analysis techniques.
• State the research objectives and research questions: Clearly state the research objectives and research questions that your study aims to answer. These should be specific, measurable, achievable, relevant, and time-bound.
• Summarize the chapter: Summarize the chapter by highlighting the key points and linking them back to the research problem, significance of the study, and research questions.

How to Write Background of The Study in Research Paper

Here are the steps to write the background of the study in a research paper:

• Identify the research problem: Start by identifying the research problem that your study aims to address. This can be a particular issue, a gap in the literature, or a need for further investigation.
• Conduct a literature review: Conduct a thorough literature review to gather information on the topic, identify existing studies, and understand the current state of research. This will help you identify the gap in the literature that your study aims to fill.
• Explain the significance of the study: Explain why your study is important and why it is necessary. This can include the potential impact on the field, the importance to society, or the need to address a particular issue.
• Provide context: Provide context for the research problem by discussing the broader social, economic, or political context that the study is situated in. This can help the reader understand the relevance of the study and its potential implications.
• State the research questions and objectives: State the research questions and objectives that your study aims to address. This will help the reader understand the scope of the study and its purpose.
• Summarize the methodology : Briefly summarize the methodology you used to conduct the study, including the data collection and analysis methods. This can help the reader understand how the study was conducted and its reliability.

Examples of Background of The Study

Here are some examples of the background of the study:

Problem : The prevalence of obesity among children in the United States has reached alarming levels, with nearly one in five children classified as obese.

Significance : Obesity in childhood is associated with numerous negative health outcomes, including increased risk of type 2 diabetes, cardiovascular disease, and certain cancers.

Gap in knowledge : Despite efforts to address the obesity epidemic, rates continue to rise. There is a need for effective interventions that target the unique needs of children and their families.

Problem : The use of antibiotics in agriculture has contributed to the development of antibiotic-resistant bacteria, which poses a significant threat to human health.

Significance : Antibiotic-resistant infections are responsible for thousands of deaths each year and are a major public health concern.

Gap in knowledge: While there is a growing body of research on the use of antibiotics in agriculture, there is still much to be learned about the mechanisms of resistance and the most effective strategies for reducing antibiotic use.

Edxample 3:

Problem : Many low-income communities lack access to healthy food options, leading to high rates of food insecurity and diet-related diseases.

Significance : Poor nutrition is a major contributor to chronic diseases such as obesity, type 2 diabetes, and cardiovascular disease.

Gap in knowledge : While there have been efforts to address food insecurity, there is a need for more research on the barriers to accessing healthy food in low-income communities and effective strategies for increasing access.

Examples of Background of The Study In Research

Here are some real-life examples of how the background of the study can be written in different fields of study:

Example 1 : “There has been a significant increase in the incidence of diabetes in recent years. This has led to an increased demand for effective diabetes management strategies. The purpose of this study is to evaluate the effectiveness of a new diabetes management program in improving patient outcomes.”

Example 2 : “The use of social media has become increasingly prevalent in modern society. Despite its popularity, little is known about the effects of social media use on mental health. This study aims to investigate the relationship between social media use and mental health in young adults.”

Example 3: “Despite significant advancements in cancer treatment, the survival rate for patients with pancreatic cancer remains low. The purpose of this study is to identify potential biomarkers that can be used to improve early detection and treatment of pancreatic cancer.”

Examples of Background of The Study in Proposal

Here are some real-time examples of the background of the study in a proposal:

Example 1 : The prevalence of mental health issues among university students has been increasing over the past decade. This study aims to investigate the causes and impacts of mental health issues on academic performance and wellbeing.

Example 2 : Climate change is a global issue that has significant implications for agriculture in developing countries. This study aims to examine the adaptive capacity of smallholder farmers to climate change and identify effective strategies to enhance their resilience.

Example 3 : The use of social media in political campaigns has become increasingly common in recent years. This study aims to analyze the effectiveness of social media campaigns in mobilizing young voters and influencing their voting behavior.

Example 4 : Employee turnover is a major challenge for organizations, especially in the service sector. This study aims to identify the key factors that influence employee turnover in the hospitality industry and explore effective strategies for reducing turnover rates.

Examples of Background of The Study in Thesis

Here are some real-time examples of the background of the study in the thesis:

Example 1 : “Women’s participation in the workforce has increased significantly over the past few decades. However, women continue to be underrepresented in leadership positions, particularly in male-dominated industries such as technology. This study aims to examine the factors that contribute to the underrepresentation of women in leadership roles in the technology industry, with a focus on organizational culture and gender bias.”

Example 2 : “Mental health is a critical component of overall health and well-being. Despite increased awareness of the importance of mental health, there are still significant gaps in access to mental health services, particularly in low-income and rural communities. This study aims to evaluate the effectiveness of a community-based mental health intervention in improving mental health outcomes in underserved populations.”

Example 3: “The use of technology in education has become increasingly widespread, with many schools adopting online learning platforms and digital resources. However, there is limited research on the impact of technology on student learning outcomes and engagement. This study aims to explore the relationship between technology use and academic achievement among middle school students, as well as the factors that mediate this relationship.”

Examples of Background of The Study in Research Paper

Here are some examples of how the background of the study can be written in various fields:

Example 1: The prevalence of obesity has been on the rise globally, with the World Health Organization reporting that approximately 650 million adults were obese in 2016. Obesity is a major risk factor for several chronic diseases such as diabetes, cardiovascular diseases, and cancer. In recent years, several interventions have been proposed to address this issue, including lifestyle changes, pharmacotherapy, and bariatric surgery. However, there is a lack of consensus on the most effective intervention for obesity management. This study aims to investigate the efficacy of different interventions for obesity management and identify the most effective one.

Example 2: Antibiotic resistance has become a major public health threat worldwide. Infections caused by antibiotic-resistant bacteria are associated with longer hospital stays, higher healthcare costs, and increased mortality. The inappropriate use of antibiotics is one of the main factors contributing to the development of antibiotic resistance. Despite numerous efforts to promote the rational use of antibiotics, studies have shown that many healthcare providers continue to prescribe antibiotics inappropriately. This study aims to explore the factors influencing healthcare providers’ prescribing behavior and identify strategies to improve antibiotic prescribing practices.

Example 3: Social media has become an integral part of modern communication, with millions of people worldwide using platforms such as Facebook, Twitter, and Instagram. Social media has several advantages, including facilitating communication, connecting people, and disseminating information. However, social media use has also been associated with several negative outcomes, including cyberbullying, addiction, and mental health problems. This study aims to investigate the impact of social media use on mental health and identify the factors that mediate this relationship.

Purpose of Background of The Study

The primary purpose of the background of the study is to help the reader understand the rationale for the research by presenting the historical, theoretical, and empirical background of the problem.

More specifically, the background of the study aims to:

• Provide a clear understanding of the research problem and its context.
• Identify the gap in knowledge that the study intends to fill.
• Establish the significance of the research problem and its potential contribution to the field.
• Highlight the key concepts, theories, and research findings related to the problem.
• Provide a rationale for the research questions or hypotheses and the research design.
• Identify the limitations and scope of the study.

When to Write Background of The Study

The background of the study should be written early on in the research process, ideally before the research design is finalized and data collection begins. This allows the researcher to clearly articulate the rationale for the study and establish a strong foundation for the research.

The background of the study typically comes after the introduction but before the literature review section. It should provide an overview of the research problem and its context, and also introduce the key concepts, theories, and research findings related to the problem.

Writing the background of the study early on in the research process also helps to identify potential gaps in knowledge and areas for further investigation, which can guide the development of the research questions or hypotheses and the research design. By establishing the significance of the research problem and its potential contribution to the field, the background of the study can also help to justify the research and secure funding or support from stakeholders.

Advantage of Background of The Study

The background of the study has several advantages, including:

• Provides context: The background of the study provides context for the research problem by highlighting the historical, theoretical, and empirical background of the problem. This allows the reader to understand the research problem in its broader context and appreciate its significance.
• Identifies gaps in knowledge: By reviewing the existing literature related to the research problem, the background of the study can identify gaps in knowledge that the study intends to fill. This helps to establish the novelty and originality of the research and its potential contribution to the field.
• Justifies the research : The background of the study helps to justify the research by demonstrating its significance and potential impact. This can be useful in securing funding or support for the research.
• Guides the research design: The background of the study can guide the development of the research questions or hypotheses and the research design by identifying key concepts, theories, and research findings related to the problem. This ensures that the research is grounded in existing knowledge and is designed to address the research problem effectively.
• Establishes credibility: By demonstrating the researcher’s knowledge of the field and the research problem, the background of the study can establish the researcher’s credibility and expertise, which can enhance the trustworthiness and validity of the research.

Disadvantages of Background of The Study

Some Disadvantages of Background of The Study are as follows:

• Time-consuming : Writing a comprehensive background of the study can be time-consuming, especially if the research problem is complex and multifaceted. This can delay the research process and impact the timeline for completing the study.
• Repetitive: The background of the study can sometimes be repetitive, as it often involves summarizing existing research and theories related to the research problem. This can be tedious for the reader and may make the section less engaging.
• Limitations of existing research: The background of the study can reveal the limitations of existing research related to the problem. This can create challenges for the researcher in developing research questions or hypotheses that address the gaps in knowledge identified in the background of the study.
• Bias : The researcher’s biases and perspectives can influence the content and tone of the background of the study. This can impact the reader’s perception of the research problem and may influence the validity of the research.
• Accessibility: Accessing and reviewing the literature related to the research problem can be challenging, especially if the researcher does not have access to a comprehensive database or if the literature is not available in the researcher’s language. This can limit the depth and scope of the background of the study.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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How to Write an Effective Background of the Study: A Comprehensive Guide

Table of Contents

The background of the study in a research paper offers a clear context, highlighting why the research is essential and the problem it aims to address.

As a researcher, this foundational section is essential for you to chart the course of your study, Moreover, it allows readers to understand the importance and path of your research.

Whether in academic communities or to the general public, a well-articulated background aids in communicating the essence of the research effectively.

While it may seem straightforward, crafting an effective background requires a blend of clarity, precision, and relevance. Therefore, this article aims to be your guide, offering insights into:

• Understanding the concept of the background of the study.
• Learning how to craft a compelling background effectively.
• Identifying and sidestepping common pitfalls in writing the background.
• Exploring practical examples that bring the theory to life.
• Enhancing both your writing and reading of academic papers.

Keeping these compelling insights in mind, let's delve deeper into the details of the empirical background of the study, exploring its definition, distinctions, and the art of writing it effectively.

What is the background of the study?

The background of the study is placed at the beginning of a research paper. It provides the context, circumstances, and history that led to the research problem or topic being explored.

It offers readers a snapshot of the existing knowledge on the topic and the reasons that spurred your current research.

When crafting the background of your study, consider the following questions.

• What's the context of your research?
• Which previous research will you refer to?
• Are there any knowledge gaps in the existing relevant literature?
• How will you justify the need for your current research?
• Have you concisely presented the research question or problem?

In a typical research paper structure, after presenting the background, the introduction section follows. The introduction delves deeper into the specific objectives of the research and often outlines the structure or main points that the paper will cover.

Together, they create a cohesive starting point, ensuring readers are well-equipped to understand the subsequent sections of the research paper.

While the background of the study and the introduction section of the research manuscript may seem similar and sometimes even overlap, each serves a unique purpose in the research narrative.

Difference between background and introduction

A well-written background of the study and introduction are preliminary sections of a research paper and serve distinct purposes.

Here’s a detailed tabular comparison between the two of them.

What is the relevance of the background of the study?

It is necessary for you to provide your readers with the background of your research. Without this, readers may grapple with questions such as: Why was this specific research topic chosen? What led to this decision? Why is this study relevant? Is it worth their time?

Such uncertainties can deter them from fully engaging with your study, leading to the rejection of your research paper. Additionally, this can diminish its impact in the academic community, and reduce its potential for real-world application or policy influence .

To address these concerns and offer clarity, the background section plays a pivotal role in research papers.

The background of the study in research is important as it:

• Provides context: It offers readers a clear picture of the existing knowledge, helping them understand where the current research fits in.
• Highlights relevance: By detailing the reasons for the research, it underscores the study's significance and its potential impact.
• Guides the narrative: The background shapes the narrative flow of the paper, ensuring a logical progression from what's known to what the research aims to uncover.
• Enhances engagement: A well-crafted background piques the reader's interest, encouraging them to delve deeper into the research paper.
• Aids in comprehension: By setting the scenario, it aids readers in better grasping the research objectives, methodologies, and findings.

How to write the background of the study in a research paper?

The journey of presenting a compelling argument begins with the background study. This section holds the power to either captivate or lose the reader's interest.

An effectively written background not only provides context but also sets the tone for the entire research paper. It's the bridge that connects a broad topic to a specific research question, guiding readers through the logic behind the study.

But how does one craft a background of the study that resonates, informs, and engages?

Here, we’ll discuss how to write an impactful background study, ensuring your research stands out and captures the attention it deserves.

Identify the research problem

The first step is to start pinpointing the specific issue or gap you're addressing. This should be a significant and relevant problem in your field.

A well-defined problem is specific, relevant, and significant to your field. It should resonate with both experts and readers.

Here’s more on how to write an effective research problem .

Provide context

Here, you need to provide a broader perspective, illustrating how your research aligns with or contributes to the overarching context or the wider field of study. A comprehensive context is grounded in facts, offers multiple perspectives, and is relatable.

In addition to stating facts, you should weave a story that connects key concepts from the past, present, and potential future research. For instance, consider the following approach.

• Offer a brief history of the topic, highlighting major milestones or turning points that have shaped the current landscape.
• Discuss contemporary developments or current trends that provide relevant information to your research problem. This could include technological advancements, policy changes, or shifts in societal attitudes.
• Highlight the views of different stakeholders. For a topic like sustainable agriculture, this could mean discussing the perspectives of farmers, environmentalists, policymakers, and consumers.
• If relevant, compare and contrast global trends with local conditions and circumstances. This can offer readers a more holistic understanding of the topic.

Literature review

For this step, you’ll deep dive into the existing literature on the same topic. It's where you explore what scholars, researchers, and experts have already discovered or discussed about your topic.

Conducting a thorough literature review isn't just a recap of past works. To elevate its efficacy, it's essential to analyze the methods, outcomes, and intricacies of prior research work, demonstrating a thorough engagement with the existing body of knowledge.

• Instead of merely listing past research study, delve into their methodologies, findings, and limitations. Highlight groundbreaking studies and those that had contrasting results.
• Try to identify patterns. Look for recurring themes or trends in the literature. Are there common conclusions or contentious points?
• The next step would be to connect the dots. Show how different pieces of research relate to each other. This can help in understanding the evolution of thought on the topic.

By showcasing what's already known, you can better highlight the background of the study in research.

Highlight the research gap

This step involves identifying the unexplored areas or unanswered questions in the existing literature. Your research seeks to address these gaps, providing new insights or answers.

A clear research gap shows you've thoroughly engaged with existing literature and found an area that needs further exploration.

How can you efficiently highlight the research gap?

• Find the overlooked areas. Point out topics or angles that haven't been adequately addressed.
• Highlight questions that have emerged due to recent developments or changing circumstances.
• Identify areas where insights from other fields might be beneficial but haven't been explored yet.

State your objectives

Here, it’s all about laying out your game plan — What do you hope to achieve with your research? You need to mention a clear objective that’s specific, actionable, and directly tied to the research gap.

How to state your objectives?

• List the primary questions guiding your research.
• If applicable, state any hypotheses or predictions you aim to test.
• Specify what you hope to achieve, whether it's new insights, solutions, or methodologies.

Discuss the significance

This step describes your 'why'. Why is your research important? What broader implications does it have?

The significance of “why” should be both theoretical (adding to the existing literature) and practical (having real-world implications).

How do we effectively discuss the significance?

• Discuss how your research adds to the existing body of knowledge.
• Highlight how your findings could be applied in real-world scenarios, from policy changes to on-ground practices.
• Point out how your research could pave the way for further studies or open up new areas of exploration.

Summarize your points

A concise summary acts as a bridge, smoothly transitioning readers from the background to the main body of the paper. This step is a brief recap, ensuring that readers have grasped the foundational concepts.

How to summarize your study?

• Revisit the key points discussed, from the research problem to its significance.
• Prepare the reader for the subsequent sections, ensuring they understand the research's direction.

Include examples for better understanding

Research and come up with real-world or hypothetical examples to clarify complex concepts or to illustrate the practical applications of your research. Relevant examples make abstract ideas tangible, aiding comprehension.

How to include an effective example of the background of the study?

• Use past events or scenarios to explain concepts.
• Craft potential scenarios to demonstrate the implications of your findings.
• Use comparisons to simplify complex ideas, making them more relatable.

Crafting a compelling background of the study in research is about striking the right balance between providing essential context, showcasing your comprehensive understanding of the existing literature, and highlighting the unique value of your research .

While writing the background of the study, keep your readers at the forefront of your mind. Every piece of information, every example, and every objective should be geared toward helping them understand and appreciate your research.

How to avoid mistakes in the background of the study in research?

To write a well-crafted background of the study, you should be aware of the following potential research pitfalls .

• Stay away from ambiguity. Always assume that your reader might not be familiar with intricate details about your topic.
• Avoid discussing unrelated themes. Stick to what's directly relevant to your research problem.
• Ensure your background is well-organized. Information should flow logically, making it easy for readers to follow.
• While it's vital to provide context, avoid overwhelming the reader with excessive details that might not be directly relevant to your research problem.
• Ensure you've covered the most significant and relevant studies i` n your field. Overlooking key pieces of literature can make your background seem incomplete.
• Aim for a balanced presentation of facts, and avoid showing overt bias or presenting only one side of an argument.
• While academic paper often involves specialized terms, ensure they're adequately explained or use simpler alternatives when possible.
• Every claim or piece of information taken from existing literature should be appropriately cited. Failing to do so can lead to issues of plagiarism.
• Avoid making the background too lengthy. While thoroughness is appreciated, it should not come at the expense of losing the reader's interest. Maybe prefer to keep it to one-two paragraphs long.
• Especially in rapidly evolving fields, it's crucial to ensure that your literature review section is up-to-date and includes the latest research.

Example of an effective background of the study

Let's consider a topic: "The Impact of Online Learning on Student Performance." The ideal background of the study section for this topic would be as follows.

In the last decade, the rise of the internet has revolutionized many sectors, including education. Online learning platforms, once a supplementary educational tool, have now become a primary mode of instruction for many institutions worldwide. With the recent global events, such as the COVID-19 pandemic, there has been a rapid shift from traditional classroom learning to online modes, making it imperative to understand its effects on student performance.

Previous studies have explored various facets of online learning, from its accessibility to its flexibility. However, there is a growing need to assess its direct impact on student outcomes. While some educators advocate for its benefits, citing the convenience and vast resources available, others express concerns about potential drawbacks, such as reduced student engagement and the challenges of self-discipline.

This research aims to delve deeper into this debate, evaluating the true impact of online learning on student performance.

Why is this example considered as an effective background section of a research paper?

This background section example effectively sets the context by highlighting the rise of online learning and its increased relevance due to recent global events. It references prior research on the topic, indicating a foundation built on existing knowledge.

By presenting both the potential advantages and concerns of online learning, it establishes a balanced view, leading to the clear purpose of the study: to evaluate the true impact of online learning on student performance.

As we've explored, writing an effective background of the study in research requires clarity, precision, and a keen understanding of both the broader landscape and the specific details of your topic.

From identifying the research problem, providing context, reviewing existing literature to highlighting research gaps and stating objectives, each step is pivotal in shaping the narrative of your research. And while there are best practices to follow, it's equally crucial to be aware of the pitfalls to avoid.

Remember, writing or refining the background of your study is essential to engage your readers, familiarize them with the research context, and set the ground for the insights your research project will unveil.

Drawing from all the important details, insights and guidance shared, you're now in a strong position to craft a background of the study that not only informs but also engages and resonates with your readers.

Now that you've a clear understanding of what the background of the study aims to achieve, the natural progression is to delve into the next crucial component — write an effective introduction section of a research paper. Read here .

Frequently Asked Questions

The background of the study should include a clear context for the research, references to relevant previous studies, identification of knowledge gaps, justification for the current research, a concise overview of the research problem or question, and an indication of the study's significance or potential impact.

The background of the study is written to provide readers with a clear understanding of the context, significance, and rationale behind the research. It offers a snapshot of existing knowledge on the topic, highlights the relevance of the study, and sets the stage for the research questions and objectives. It ensures that readers can grasp the importance of the research and its place within the broader field of study.

The background of the study is a section in a research paper that provides context, circumstances, and history leading to the research problem or topic being explored. It presents existing knowledge on the topic and outlines the reasons that spurred the current research, helping readers understand the research's foundation and its significance in the broader academic landscape.

The number of paragraphs in the background of the study can vary based on the complexity of the topic and the depth of the context required. Typically, it might range from 3 to 5 paragraphs, but in more detailed or complex research papers, it could be longer. The key is to ensure that all relevant information is presented clearly and concisely, without unnecessary repetition.

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How To Write A Dissertation Introduction Chapter:

The 7 essential ingredients of an a-grade introduction.

By: Derek Jansen (MBA). Reviewed By Dr Eunice Rautenbach (D. Tech) | March 2020

If you’re reading this, you’re probably at the daunting early phases of writing up the introduction chapter of your dissertation or thesis. It can be intimidating, I know. 

In this post, we’ll look at the 7 essential ingredients of a strong dissertation or thesis introduction chapter, as well as the essential things you need to keep in mind as you craft each section. We’ll also share some useful tips to help you optimize your approach.

Overview: How To Write An Introduction Chapter

• Understand the purpose and function of the intro chapter
• Craft an enticing and engaging opening section
• Provide a background and context to the study
• Clearly define the research problem
• State your research aims, objectives and questions
• Explain the significance of your study
• Identify the limitations of your research
• Outline the structure of your dissertation or thesis

A quick sidenote:

You’ll notice that I’ve used the words dissertation and thesis interchangeably. While these terms reflect different levels of research – for example, Masters vs PhD-level research – the introduction chapter generally contains the same 7 essential ingredients regardless of level. So, in this post, dissertation introduction equals thesis introduction.

Start with why.

To craft a high-quality dissertation or thesis introduction chapter, you need to understand exactly what this chapter needs to achieve. In other words, what’s its purpose ? As the name suggests, the introduction chapter needs to introduce the reader to your research so that they understand what you’re trying to figure out, or what problem you’re trying to solve. More specifically, you need to answer four important questions in your introduction chapter.

These questions are:

• What will you be researching? (in other words, your research topic)
• Why is that worthwhile? (in other words, your justification)
• What will the scope of your research be? (in other words, what will you cover and what won’t you cover)
• What will the limitations of your research be? (in other words, what will the potential shortcomings of your research be?)

Simply put, your dissertation’s introduction chapter needs to provide an overview of your planned research , as well as a clear rationale for it. In other words, this chapter has to explain the “what” and the “why” of your research – what’s it all about and why’s that important.

Simple enough, right?

Well, the trick is finding the appropriate depth of information. As the researcher, you’ll be extremely close to your topic and this makes it easy to get caught up in the minor details. While these intricate details might be interesting, you need to write your introduction chapter on more of a “need-to-know” type basis, or it will end up way too lengthy and dense. You need to balance painting a clear picture with keeping things concise. Don’t worry though – you’ll be able to explore all the intricate details in later chapters.

Now that you understand what you need to achieve from your introduction chapter, we can get into the details. While the exact requirements for this chapter can vary from university to university, there are seven core components that most universities will require. We call these the seven essential ingredients . 

The 7 Essential Ingredients

• The opening section – where you’ll introduce the reader to your research in high-level terms
• The background to the study – where you’ll explain the context of your project
• The research problem – where you’ll explain the “gap” that exists in the current research
• The research aims , objectives and questions – where you’ll clearly state what your research will aim to achieve
• The significance (or justification) – where you’ll explain why your research is worth doing and the value it will provide to the world
• The limitations – where you’ll acknowledge the potential limitations of your project and approach
• The structure – where you’ll briefly outline the structure of your dissertation or thesis to help orient the reader

By incorporating these seven essential ingredients into your introduction chapter, you’ll comprehensively cover both the “ what ” and the “ why ” I mentioned earlier – in other words, you’ll achieve the purpose of the chapter.

Side note – you can also use these 7 ingredients in this order as the structure for your chapter to ensure a smooth, logical flow. This isn’t essential, but, generally speaking, it helps create an engaging narrative that’s easy for your reader to understand. If you’d like, you can also download our free introduction chapter template here.

Alright – let’s look at each of the ingredients now.

#1 – The Opening Section

The very first essential ingredient for your dissertation introduction is, well, an introduction or opening section. Just like every other chapter, your introduction chapter needs to start by providing a brief overview of what you’ll be covering in the chapter.

This section needs to engage the reader with clear, concise language that can be easily understood and digested. If the reader (your marker!) has to struggle through it, they’ll lose interest, which will make it harder for you to earn marks. Just because you’re writing an academic paper doesn’t mean you can ignore the basic principles of engaging writing used by marketers, bloggers, and journalists. At the end of the day, you’re all trying to sell an idea – yours is just a research idea.

So, what goes into this opening section?

Well, while there’s no set formula, it’s a good idea to include the following four foundational sentences in your opening section:

1 – A sentence or two introducing the overall field of your research.

For example:

“Organisational skills development involves identifying current or potential skills gaps within a business and developing programs to resolve these gaps. Management research, including X, Y and Z, has clearly established that organisational skills development is an essential contributor to business growth.”

2 – A sentence introducing your specific research problem.

“However, there are conflicting views and an overall lack of research regarding how best to manage skills development initiatives in highly dynamic environments where subject knowledge is rapidly and continuously evolving – for example, in the website development industry.”

3 – A sentence stating your research aims and objectives.

“This research aims to identify and evaluate skills development approaches and strategies for highly dynamic industries in which subject knowledge is continuously evolving.”.

4 – A sentence outlining the layout of the chapter.

“This chapter will provide an introduction to the study by first discussing the background and context, followed by the research problem, the research aims, objectives and questions, the significance and finally, the limitations.”

As I mentioned, this opening section of your introduction chapter shouldn’t be lengthy . Typically, these four sentences should fit neatly into one or two paragraphs, max. What you’re aiming for here is a clear, concise introduction to your research – not a detailed account.

PS – If some of this terminology sounds unfamiliar, don’t stress – I’ll explain each of the concepts later in this post.

#2 – Background to the study

Now that you’ve provided a high-level overview of your dissertation or thesis, it’s time to go a little deeper and lay a foundation for your research topic. This foundation is what the second ingredient is all about – the background to your study.

So, what is the background section all about?

Well, this section of your introduction chapter should provide a broad overview of the topic area that you’ll be researching, as well as the current contextual factors . This could include, for example, a brief history of the topic, recent developments in the area, key pieces of research in the area and so on. In other words, in this section, you need to provide the relevant background information to give the reader a decent foundational understanding of your research area.

Let’s look at an example to make this a little more concrete.

If we stick with the skills development topic I mentioned earlier, the background to the study section would start by providing an overview of the skills development area and outline the key existing research. Then, it would go on to discuss how the modern-day context has created a new challenge for traditional skills development strategies and approaches. Specifically, that in many industries, technical knowledge is constantly and rapidly evolving, and traditional education providers struggle to keep up with the pace of new technologies.

Importantly, you need to write this section with the assumption that the reader is not an expert in your topic area. So, if there are industry-specific jargon and complex terminology, you should briefly explain that here , so that the reader can understand the rest of your document.

Don’t make assumptions about the reader’s knowledge – in most cases, your markers will not be able to ask you questions if they don’t understand something. So, always err on the safe side and explain anything that’s not common knowledge.

#3 – The research problem

Now that you’ve given your reader an overview of your research area, it’s time to get specific about the research problem that you’ll address in your dissertation or thesis. While the background section would have alluded to a potential research problem (or even multiple research problems), the purpose of this section is to narrow the focus and highlight the specific research problem you’ll focus on.

But, what exactly is a research problem, you ask?

Well, a research problem can be any issue or question for which there isn’t already a well-established and agreed-upon answer in the existing research. In other words, a research problem exists when there’s a need to answer a question (or set of questions), but there’s a gap in the existing literature , or the existing research is conflicting and/or inconsistent.

So, to present your research problem, you need to make it clear what exactly is missing in the current literature and why this is a problem . It’s usually a good idea to structure this discussion into three sections – specifically:

• What’s already well-established in the literature (in other words, the current state of research)
• What’s missing in the literature (in other words, the literature gap)
• Why this is a problem (in other words, why it’s important to fill this gap)

Let’s look at an example of this structure using the skills development topic.

Organisational skills development is critically important for employee satisfaction and company performance (reference). Numerous studies have investigated strategies and approaches to manage skills development programs within organisations (reference).

(this paragraph explains what’s already well-established in the literature)

However, these studies have traditionally focused on relatively slow-paced industries where key skills and knowledge do not change particularly often. This body of theory presents a problem for industries that face a rapidly changing skills landscape – for example, the website development industry – where new platforms, languages and best practices emerge on an extremely frequent basis.

(this paragraph explains what’s missing from the literature)

As a result, the existing research is inadequate for industries in which essential knowledge and skills are constantly and rapidly evolving, as it assumes a slow pace of knowledge development. Industries in such environments, therefore, find themselves ill-equipped in terms of skills development strategies and approaches.

(this paragraph explains why the research gap is problematic)

As you can see in this example, in a few lines, we’ve explained (1) the current state of research, (2) the literature gap and (3) why that gap is problematic. By doing this, the research problem is made crystal clear, which lays the foundation for the next ingredient.

#4 – The research aims, objectives and questions

Now that you’ve clearly identified your research problem, it’s time to identify your research aims and objectives , as well as your research questions . In other words, it’s time to explain what you’re going to do about the research problem.

So, what do you need to do here?

Well, the starting point is to clearly state your research aim (or aims) . The research aim is the main goal or the overarching purpose of your dissertation or thesis. In other words, it’s a high-level statement of what you’re aiming to achieve.

Let’s look at an example, sticking with the skills development topic:

“Given the lack of research regarding organisational skills development in fast-moving industries, this study will aim to identify and evaluate the skills development approaches utilised by web development companies in the UK”.

As you can see in this example, the research aim is clearly outlined, as well as the specific context in which the research will be undertaken (in other words, web development companies in the UK).

Next up is the research objective (or objectives) . While the research aims cover the high-level “what”, the research objectives are a bit more practically oriented, looking at specific things you’ll be doing to achieve those research aims.

Let’s take a look at an example of some research objectives (ROs) to fit the research aim.

• RO1 – To identify common skills development strategies and approaches utilised by web development companies in the UK.
• RO2 – To evaluate the effectiveness of these strategies and approaches.
• RO3 – To compare and contrast these strategies and approaches in terms of their strengths and weaknesses.

As you can see from this example, these objectives describe the actions you’ll take and the specific things you’ll investigate in order to achieve your research aims. They break down the research aims into more specific, actionable objectives.

The final step is to state your research questions . Your research questions bring the aims and objectives another level “down to earth”. These are the specific questions that your dissertation or theses will seek to answer. They’re not fluffy, ambiguous or conceptual – they’re very specific and you’ll need to directly answer them in your conclusions chapter .

The research questions typically relate directly to the research objectives and sometimes can look a bit obvious, but they are still extremely important. Let’s take a look at an example of the research questions (RQs) that would flow from the research objectives I mentioned earlier.

• RQ1 – What skills development strategies and approaches are currently being used by web development companies in the UK?
• RQ2 – How effective are each of these strategies and approaches?
• RQ3 – What are the strengths and weaknesses of each of these strategies and approaches?

As you can see, the research questions mimic the research objectives , but they are presented in question format. These questions will act as the driving force throughout your dissertation or thesis – from the literature review to the methodology and onward – so they’re really important.

A final note about this section – it’s really important to be clear about the scope of your study (more technically, the delimitations ). In other words, what you WILL cover and what you WON’T cover. If your research aims, objectives and questions are too broad, you’ll risk losing focus or investigating a problem that is too big to solve within a single dissertation.

Simply put, you need to establish clear boundaries in your research. You can do this, for example, by limiting it to a specific industry, country or time period. That way, you’ll ringfence your research, which will allow you to investigate your topic deeply and thoroughly – which is what earns marks!

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#5 – Significance

Now that you’ve made it clear what you’ll be researching, it’s time to make a strong argument regarding your study’s importance and significance . In other words, now that you’ve covered the what, it’s time to cover the why – enter essential ingredient number 5 – significance.

Of course, by this stage, you’ve already briefly alluded to the importance of your study in your background and research problem sections, but you haven’t explicitly stated how your research findings will benefit the world . So, now’s your chance to clearly state how your study will benefit either industry , academia , or – ideally – both . In other words, you need to explain how your research will make a difference and what implications it will have.

Let’s take a look at an example.

“This study will contribute to the body of knowledge on skills development by incorporating skills development strategies and approaches for industries in which knowledge and skills are rapidly and constantly changing. This will help address the current shortage of research in this area and provide real-world value to organisations operating in such dynamic environments.”

As you can see in this example, the paragraph clearly explains how the research will help fill a gap in the literature and also provide practical real-world value to organisations.

This section doesn’t need to be particularly lengthy, but it does need to be convincing . You need to “sell” the value of your research here so that the reader understands why it’s worth committing an entire dissertation or thesis to it. This section needs to be the salesman of your research. So, spend some time thinking about the ways in which your research will make a unique contribution to the world and how the knowledge you create could benefit both academia and industry – and then “sell it” in this section.

#6 – The limitations

Now that you’ve “sold” your research to the reader and hopefully got them excited about what’s coming up in the rest of your dissertation, it’s time to briefly discuss the potential limitations of your research.

But you’re probably thinking, hold up – what limitations? My research is well thought out and carefully designed – why would there be limitations?

Well, no piece of research is perfect . This is especially true for a dissertation or thesis – which typically has a very low or zero budget, tight time constraints and limited researcher experience. Generally, your dissertation will be the first or second formal research project you’ve ever undertaken, so it’s unlikely to win any research awards…

Simply put, your research will invariably have limitations. Don’t stress yourself out though – this is completely acceptable (and expected). Even “professional” research has limitations – as I said, no piece of research is perfect. The key is to recognise the limitations upfront and be completely transparent about them, so that future researchers are aware of them and can improve the study’s design to minimise the limitations and strengthen the findings.

Generally, you’ll want to consider at least the following four common limitations. These are:

• Your scope – for example, perhaps your focus is very narrow and doesn’t consider how certain variables interact with each other.
• Your research methodology – for example, a qualitative methodology could be criticised for being overly subjective, or a quantitative methodology could be criticised for oversimplifying the situation (learn more about methodologies here ).
• Your resources – for example, a lack of time, money, equipment and your own research experience.
• The generalisability of your findings – for example, the findings from the study of a specific industry or country can’t necessarily be generalised to other industries or countries.

Don’t be shy here. There’s no use trying to hide the limitations or weaknesses of your research. In fact, the more critical you can be of your study, the better. The markers want to see that you are aware of the limitations as this demonstrates your understanding of research design – so be brutal.

#7 – The structural outline

Now that you’ve clearly communicated what your research is going to be about, why it’s important and what the limitations of your research will be, the final ingredient is the structural outline.The purpose of this section is simply to provide your reader with a roadmap of what to expect in terms of the structure of your dissertation or thesis.

In this section, you’ll need to provide a brief summary of each chapter’s purpose and contents (including the introduction chapter). A sentence or two explaining what you’ll do in each chapter is generally enough to orient the reader. You don’t want to get too detailed here – it’s purely an outline, not a summary of your research.

Let’s look at an example:

In Chapter One, the context of the study has been introduced. The research objectives and questions have been identified, and the value of such research argued. The limitations of the study have also been discussed.

In Chapter Two, the existing literature will be reviewed and a foundation of theory will be laid out to identify key skills development approaches and strategies within the context of fast-moving industries, especially technology-intensive industries.

In Chapter Three, the methodological choices will be explored. Specifically, the adoption of a qualitative, inductive research approach will be justified, and the broader research design will be discussed, including the limitations thereof.

So, as you can see from the example, this section is simply an outline of the chapter structure, allocating a short paragraph to each chapter. Done correctly, the outline will help your reader understand what to expect and reassure them that you’ll address the multiple facets of the study.

By the way – if you’re unsure of how to structure your dissertation or thesis, be sure to check out our video post which explains dissertation structure .

Keep calm and carry on.

Hopefully you feel a bit more prepared for this challenge of crafting your dissertation or thesis introduction chapter now. Take a deep breath and remember that Rome wasn’t built in a day – conquer one ingredient at a time and you’ll be firmly on the path to success.

Let’s quickly recap – the 7 ingredients are:

• The opening section – where you give a brief, high-level overview of what your research will be about.
• The study background – where you introduce the reader to key theory, concepts and terminology, as well as the context of your study.
• The research problem – where you explain what the problem with the current research is. In other words, the research gap.
• The research aims , objectives and questions – where you clearly state what your dissertation will investigate.
• The significance – where you explain what value your research will provide to the world.
• The limitations – where you explain what the potential shortcomings and limitations of your research may be.
• The structural outline – where you provide a high-level overview of the structure of your document

If you bake these ingredients into your dissertation introduction chapter, you’ll be well on your way to building an engaging introduction chapter that lays a rock-solid foundation for the rest of your document.

Remember, while we’ve covered the essential ingredients here, there may be some additional components that your university requires, so be sure to double-check your project brief!

Psst… there’s more (for free)

This post is part of our dissertation mini-course, which covers everything you need to get started with your dissertation, thesis or research project. 

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42 Comments

Thanks very much for such an insight. I feel confident enough in undertaking my thesis on the survey;The future of facial recognition and learning non verbal interaction

Glad to hear that. Good luck with your thesis!

Thanks very much for such an insight. I feel confident now undertaking my thesis; The future of facial recognition and learning non verbal interaction.

Thanks so much for this article. I found myself struggling and wasting a lot of time in my thesis writing but after reading this article and watching some of your youtube videos, I now have a clear understanding of what is required for a thesis.

Thank you Derek, i find your each post so useful. Keep it up.

Thank you so much Derek ,for shedding the light and making it easier for me to handle the daunting task of academic writing .

Thanks do much Dereck for the comprehensive guide. It will assist me queit a lot in my thesis.

thanks a lot for helping

i LOVE the gifs, such a fun way to engage readers. thanks for the advice, much appreciated

Thanks a lot Derek! It will be really useful to the beginner in research!

You’re welcome

This is a well written, easily comprehensible, simple introduction to the basics of a Research Dissertation../the need to keep the reader in mind while writing the dissertation is an important point that is covered../ I appreciate the efforts of the author../

The instruction given are perfect and clear. I was supposed to take the course , unfortunately in Nepal the service is not avaialble.However, I am much more hopeful that you will provide require documents whatever you have produced so far.

Thank you very much

Thanks so much ❤️😘 I feel am ready to start writing my research methodology

This is genuinely the most effective advice I have ever been given regarding academia. Thank you so much!

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I was looking for some good blogs related to Education hopefully your article will help. Thanks for sharing.

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You just saved me from going astray in writing a Dissertation for my undergraduate studies. I could not be more grateful for such a relevant guide like this. Thank you so much.

Thank you so much Derek, this has been extremely helpful!!

I do have one question though, in the limitations part do you refer to the scope as the focus of the research on a specific industry/country/chronological period? I assume that in order to talk about whether or not the research could be generalized, the above would need to be already presented and described in the introduction.

Thank you again!

Phew! You have genuinely rescued me. I was stuck how to go about my thesis. Now l have started. Thank you.

This is the very best guide in anything that has to do with thesis or dissertation writing. The numerous blends of examples and detailed insights make it worth a read and in fact, a treasure that is worthy to be bookmarked.

Thanks a lot for this masterpiece!

Powerful insight. I can now take a step

Thank you very much for these valuable introductions to thesis chapters. I saw all your videos about writing the introduction, discussion, and conclusion chapter. Then, I am wondering if we need to explain our research limitations in all three chapters, introduction, discussion, and conclusion? Isn’t it a bit redundant? If not, could you please explain how can we write in different ways? Thank you.

Excellent!!! Thank you…

Thanks for this informative content. I have a question. The research gap is mentioned in both the introduction and literature section. I would like to know how can I demonstrate the research gap in both sections without repeating the contents?

I’m incredibly grateful for this invaluable content. I’ve been dreading compiling my postgrad thesis but breaking each chapter down into sections has made it so much easier for me to engage with the material without feeling overwhelmed. After relying on your guidance, I’m really happy with how I’ve laid out my introduction.

Thank you for the informative content you provided

Hi Derrick and Team, thank you so much for the comprehensive guide on how to write a dissertation or a thesis introduction section. For some of us first-timers, it is a daunting task. However, the instruction with relevant examples makes it clear and easy to follow through. Much appreciated.

It was so helpful. God Bless you. Thanks very much

I thank you Grad coach for your priceless help. I have two questions I have learned from your video the limitations of the research presented in chapter one. but in another video also presented in chapter five. which chapter limitation should be included? If possible, I need your answer since I am doing my thesis. how can I explain If I am asked what is my motivation for this research?

Thank you guys for the great work you are doing. Honestly, you have made the research to be interesting and simplified. Even a novice will easily grasp the ideas you put forward, Thank you once again.

Excellent piece!

I feel like just settling for a good topic is usually the hardest part.

Thank you so much. My confidence has been completely destroyed during my first year of PhD and you have helped me pull myself together again

Happy to help 🙂

I am so glad I ran into your resources and did not waste time doing the wrong this. Research is now making so much sense now.

Gratitude to Derrick and the team I was looking for a solid article that would aid me in drafting the thesis’ introduction. I felt quite happy when I came across the piece you wrote because it was so well-written and insightful. I wish you success in the future.

thank you so much. God Bless you

Thank you so much Grad Coach for these helpful insights. Now I can get started, with a great deal of confidence.

It’s ‘alluded to’ not ‘eluded to’.

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What is the Background of the Study and How to Write It

What is the Background of the Study in Research? 

The background of the study is the first section of a research paper and gives context surrounding the research topic. The background explains to the reader where your research journey started, why you got interested in the topic, and how you developed the research question that you will later specify. That means that you first establish the context of the research you did with a general overview of the field or topic and then present the key issues that drove your decision to study the specific problem you chose.

Once the reader understands where you are coming from and why there was indeed a need for the research you are going to present in the following—because there was a gap in the current research, or because there is an obvious problem with a currently used process or technology—you can proceed with the formulation of your research question and summarize how you are going to address it in the rest of your manuscript.

Why is the Background of the Study Important?

No matter how surprising and important the findings of your study are, if you do not provide the reader with the necessary background information and context, they will not be able to understand your reasons for studying the specific problem you chose and why you think your study is relevant. And more importantly, an editor who does not share your enthusiasm for your work (because you did not fill them in on all the important details) will very probably not even consider your manuscript worthy of their and the reviewers’ time and will immediately send it back to you.

To avoid such desk rejections , you need to make sure you pique the reader’s interest and help them understand the contribution of your work to the specific field you study, the more general research community, or the public. Introducing the study background is crucial to setting the scene for your readers.

Table of Contents:

• What is “Background Information” in a Research Paper?
• What Should the Background of a Research Paper Include?
• Where Does the Background Section Go in Your Paper?

Background of the Study Structure

Before writing your study background, it is essential to understand what to include. The following elements should all be included in the background and are presented in greater detail in the next section:

• A general overview of the topic and why it is important (overlaps with establishing the “importance of the topic” in the Introduction)
• The current state of the research on the topic or on related topics in the field
• Controversies about current knowledge or specific past studies that undergird your research methodology
• Any claims or assumptions that have been made by researchers, institutions, or politicians that might need to be clarified
• Methods and techniques used in the study or from which your study deviated in some way

Presenting the Study Background

As you begin introducing your background, you first need to provide a general overview and include the main issues concerning the topic. Depending on whether you do “basic” (with the aim of providing further knowledge) or “applied” research (to establish new techniques, processes, or products), this is either a literature review that summarizes all relevant earlier studies in the field or a description of the process (e.g., vote counting) or practice (e.g., diagnosis of a specific disease) that you think is problematic or lacking and needs a solution.

Example s of a general overview

If you study the function of a Drosophila gene, for example, you can explain to the reader why and for whom the study of fly genetics is relevant, what is already known and established, and where you see gaps in the existing literature. If you investigated how the way universities have transitioned into online teaching since the beginning of the Covid-19 pandemic has affected students’ learning progress, then you need to present a summary of what changes have happened around the world, what the effects of those changes have been so far, and where you see problems that need to be addressed. Note that you need to provide sources for every statement and every claim you make here, to establish a solid foundation of knowledge for your own study. 

Describing the current state of knowledge

When the reader understands the main issue(s), you need to fill them in more specifically on the current state of the field (in basic research) or the process/practice/product use you describe (in practical/applied research). Cite all relevant studies that have already reported on the Drosophila gene you are interested in, have failed to reveal certain functions of it, or have suggested that it might be involved in more processes than we know so far. Or list the reports from the education ministries of the countries you are interested in and highlight the data that shows the need for research into the effects of the Corona-19 pandemic on teaching and learning.

Discussing controversies, claims, and assumptions

Are there controversies regarding your topic of interest that need to be mentioned and/or addressed? For example, if your research topic involves an issue that is politically hot, you can acknowledge this here. Have any earlier claims or assumptions been made, by other researchers, institutions, or politicians, that you think need to be clarified?

Mentioning methodologies and approaches

While putting together these details, you also need to mention methodologies : What methods/techniques have been used so far to study what you studied and why are you going to either use the same or a different approach? Are any of the methods included in the literature review flawed in such a way that your study takes specific measures to correct or update? While you shouldn’t spend too much time here justifying your methods (this can be summarized briefly in the rationale of the study at the end of the Introduction and later in the Discussion section), you can engage with the crucial methods applied in previous studies here first.

When you have established the background of the study of your research paper in such a logical way, then the reader should have had no problem following you from the more general information you introduced first to the specific details you added later. You can now easily lead over to the relevance of your research, explain how your work fits into the bigger picture, and specify the aims and objectives of your study. This latter part is usually considered the “ statement of the problem ” of your study. Without a solid research paper background, this statement will come out of nowhere for the reader and very probably raise more questions than you were planning to answer.   

Where does the study background section go in a paper?

Unless you write a research proposal or some kind of report that has a specific “Background” chapter, the background of your study is the first part of your introduction section . This is where you put your work in context and provide all the relevant information the reader needs to follow your rationale. Make sure your background has a logical structure and naturally leads into the statement of the problem at the very end of the introduction so that you bring everything together for the reader to judge the relevance of your work and the validity of your approach before they dig deeper into the details of your study in the methods section .

Consider Receiving Professional Editing Services

Now that you know how to write a background section for a research paper, you might be interested in our AI text editor at Wordvice AI. And be sure to receive professional editing services , including academic editing and proofreading , before submitting your manuscript to journals. On the Wordvice academic resources website, you can also find many more articles and other resources that can help you with writing the other parts of your research paper , with making a research paper outline before you put everything together, or with writing an effective cover letter once you are ready to submit.

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• Research paper

Writing a Research Paper Introduction | Step-by-Step Guide

Published on September 24, 2022 by Jack Caulfield . Revised on March 27, 2023.

The introduction to a research paper is where you set up your topic and approach for the reader. It has several key goals:

• Present your topic and get the reader interested
• Provide background or summarize existing research
• Position your own approach
• Detail your specific research problem and problem statement
• Give an overview of the paper’s structure

The introduction looks slightly different depending on whether your paper presents the results of original empirical research or constructs an argument by engaging with a variety of sources.

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Table of contents

Step 1: introduce your topic, step 2: describe the background, step 3: establish your research problem, step 4: specify your objective(s), step 5: map out your paper, research paper introduction examples, frequently asked questions about the research paper introduction.

The first job of the introduction is to tell the reader what your topic is and why it’s interesting or important. This is generally accomplished with a strong opening hook.

The hook is a striking opening sentence that clearly conveys the relevance of your topic. Think of an interesting fact or statistic, a strong statement, a question, or a brief anecdote that will get the reader wondering about your topic.

For example, the following could be an effective hook for an argumentative paper about the environmental impact of cattle farming:

A more empirical paper investigating the relationship of Instagram use with body image issues in adolescent girls might use the following hook:

Don’t feel that your hook necessarily has to be deeply impressive or creative. Clarity and relevance are still more important than catchiness. The key thing is to guide the reader into your topic and situate your ideas.

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This part of the introduction differs depending on what approach your paper is taking.

In a more argumentative paper, you’ll explore some general background here. In a more empirical paper, this is the place to review previous research and establish how yours fits in.

Argumentative paper: Background information

After you’ve caught your reader’s attention, specify a bit more, providing context and narrowing down your topic.

Provide only the most relevant background information. The introduction isn’t the place to get too in-depth; if more background is essential to your paper, it can appear in the body .

Empirical paper: Describing previous research

For a paper describing original research, you’ll instead provide an overview of the most relevant research that has already been conducted. This is a sort of miniature literature review —a sketch of the current state of research into your topic, boiled down to a few sentences.

This should be informed by genuine engagement with the literature. Your search can be less extensive than in a full literature review, but a clear sense of the relevant research is crucial to inform your own work.

Begin by establishing the kinds of research that have been done, and end with limitations or gaps in the research that you intend to respond to.

The next step is to clarify how your own research fits in and what problem it addresses.

Argumentative paper: Emphasize importance

In an argumentative research paper, you can simply state the problem you intend to discuss, and what is original or important about your argument.

Empirical paper: Relate to the literature

In an empirical research paper, try to lead into the problem on the basis of your discussion of the literature. Think in terms of these questions:

• What research gap is your work intended to fill?
• What limitations in previous work does it address?
• What contribution to knowledge does it make?

You can make the connection between your problem and the existing research using phrases like the following.

Now you’ll get into the specifics of what you intend to find out or express in your research paper.

The way you frame your research objectives varies. An argumentative paper presents a thesis statement, while an empirical paper generally poses a research question (sometimes with a hypothesis as to the answer).

Argumentative paper: Thesis statement

The thesis statement expresses the position that the rest of the paper will present evidence and arguments for. It can be presented in one or two sentences, and should state your position clearly and directly, without providing specific arguments for it at this point.

Empirical paper: Research question and hypothesis

The research question is the question you want to answer in an empirical research paper.

Present your research question clearly and directly, with a minimum of discussion at this point. The rest of the paper will be taken up with discussing and investigating this question; here you just need to express it.

A research question can be framed either directly or indirectly.

• This study set out to answer the following question: What effects does daily use of Instagram have on the prevalence of body image issues among adolescent girls?
• We investigated the effects of daily Instagram use on the prevalence of body image issues among adolescent girls.

If your research involved testing hypotheses , these should be stated along with your research question. They are usually presented in the past tense, since the hypothesis will already have been tested by the time you are writing up your paper.

For example, the following hypothesis might respond to the research question above:

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The final part of the introduction is often dedicated to a brief overview of the rest of the paper.

In a paper structured using the standard scientific “introduction, methods, results, discussion” format, this isn’t always necessary. But if your paper is structured in a less predictable way, it’s important to describe the shape of it for the reader.

If included, the overview should be concise, direct, and written in the present tense.

• This paper will first discuss several examples of survey-based research into adolescent social media use, then will go on to …
• This paper first discusses several examples of survey-based research into adolescent social media use, then goes on to …

Full examples of research paper introductions are shown in the tabs below: one for an argumentative paper, the other for an empirical paper.

• Argumentative paper
• Empirical paper

Are cows responsible for climate change? A recent study (RIVM, 2019) shows that cattle farmers account for two thirds of agricultural nitrogen emissions in the Netherlands. These emissions result from nitrogen in manure, which can degrade into ammonia and enter the atmosphere. The study’s calculations show that agriculture is the main source of nitrogen pollution, accounting for 46% of the country’s total emissions. By comparison, road traffic and households are responsible for 6.1% each, the industrial sector for 1%. While efforts are being made to mitigate these emissions, policymakers are reluctant to reckon with the scale of the problem. The approach presented here is a radical one, but commensurate with the issue. This paper argues that the Dutch government must stimulate and subsidize livestock farmers, especially cattle farmers, to transition to sustainable vegetable farming. It first establishes the inadequacy of current mitigation measures, then discusses the various advantages of the results proposed, and finally addresses potential objections to the plan on economic grounds.

The rise of social media has been accompanied by a sharp increase in the prevalence of body image issues among women and girls. This correlation has received significant academic attention: Various empirical studies have been conducted into Facebook usage among adolescent girls (Tiggermann & Slater, 2013; Meier & Gray, 2014). These studies have consistently found that the visual and interactive aspects of the platform have the greatest influence on body image issues. Despite this, highly visual social media (HVSM) such as Instagram have yet to be robustly researched. This paper sets out to address this research gap. We investigated the effects of daily Instagram use on the prevalence of body image issues among adolescent girls. It was hypothesized that daily Instagram use would be associated with an increase in body image concerns and a decrease in self-esteem ratings.

The introduction of a research paper includes several key elements:

• A hook to catch the reader’s interest
• Relevant background on the topic
• Details of your research problem

and your problem statement

• A thesis statement or research question
• Sometimes an overview of the paper

Don’t feel that you have to write the introduction first. The introduction is often one of the last parts of the research paper you’ll write, along with the conclusion.

This is because it can be easier to introduce your paper once you’ve already written the body ; you may not have the clearest idea of your arguments until you’ve written them, and things can change during the writing process .

The way you present your research problem in your introduction varies depending on the nature of your research paper . A research paper that presents a sustained argument will usually encapsulate this argument in a thesis statement .

A research paper designed to present the results of empirical research tends to present a research question that it seeks to answer. It may also include a hypothesis —a prediction that will be confirmed or disproved by your research.

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What is the Background of a Study and How Should it be Written?

• 3 minute read
• 852.2K views

Table of Contents

The background of a study is one of the most important components of a research paper. The quality of the background determines whether the reader will be interested in the rest of the study. Thus, to ensure that the audience is invested in reading the entire research paper, it is important to write an appealing and effective background. So, what constitutes the background of a study, and how must it be written?

What is the background of a study?

The background of a study is the first section of the paper and establishes the context underlying the research. It contains the rationale, the key problem statement, and a brief overview of research questions that are addressed in the rest of the paper. The background forms the crux of the study because it introduces an unaware audience to the research and its importance in a clear and logical manner. At times, the background may even explore whether the study builds on or refutes findings from previous studies. Any relevant information that the readers need to know before delving into the paper should be made available to them in the background.

How is a background different from the introduction?

The introduction of your research paper is presented before the background. Let’s find out what factors differentiate the background from the introduction.

• The introduction only contains preliminary data about the research topic and does not state the purpose of the study. On the contrary, the background clarifies the importance of the study in detail.
• The introduction provides an overview of the research topic from a broader perspective, while the background provides a detailed understanding of the topic.
• The introduction should end with the mention of the research questions, aims, and objectives of the study. In contrast, the background follows no such format and only provides essential context to the study.

How should one write the background of a research paper?

The length and detail presented in the background varies for different research papers, depending on the complexity and novelty of the research topic. At times, a simple background suffices, even if the study is complex. Before writing and adding details in the background, take a note of these additional points:

• Start with a strong beginning: Begin the background by defining the research topic and then identify the target audience.
• Cover key components: Explain all theories, concepts, terms, and ideas that may feel unfamiliar to the target audience thoroughly.
• Take note of important prerequisites: Go through the relevant literature in detail. Take notes while reading and cite the sources.
• Maintain a balance: Make sure that the background is focused on important details, but also appeals to a broader audience.
• Include historical data: Current issues largely originate from historical events or findings. If the research borrows information from a historical context, add relevant data in the background.
• Explain novelty: If the research study or methodology is unique or novel, provide an explanation that helps to understand the research better.
• Increase engagement: To make the background engaging, build a story around the central theme of the research

Avoid these mistakes while writing the background:

• Ambiguity: Don’t be ambiguous. While writing, assume that the reader does not understand any intricate detail about your research.
• Unrelated themes: Steer clear from topics that are not related to the key aspects of your research topic.
• Poor organization: Do not place information without a structure. Make sure that the background reads in a chronological manner and organize the sub-sections so that it flows well.

Writing the background for a research paper should not be a daunting task. But directions to go about it can always help. At Elsevier Author Services we provide essential insights on how to write a high quality, appealing, and logically structured paper for publication, beginning with a robust background. For further queries, contact our experts now!

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SME-SOCIAL MEDIA 1-3

• Study protocol
• Open access
• Published: 05 February 2022

Towards optimal treatment selection for borderline personality disorder patients (BOOTS): a study protocol for a multicenter randomized clinical trial comparing schema therapy and dialectical behavior therapy

• Carlijn J. M. Wibbelink 1 ,
• Arnoud Arntz 1 ,
• Raoul P. P. P. Grasman 1 ,
• Roland Sinnaeve 2 ,
• Michiel Boog 3 , 4 ,
• Odile M. C. Bremer 5 ,
• Eliane C. P. Dek 6 ,
• Sevinç Göral Alkan 7 ,
• Chrissy James 8 ,
• Annemieke M. Koppeschaar 9 ,
• Linda Kramer 10 ,
• Maria Ploegmakers 11 ,
• Arita Schaling 12 ,
• Faye I. Smits 13 &
• Jan H. Kamphuis 1  

BMC Psychiatry volume  22 , Article number:  89 ( 2022 ) Cite this article

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Specialized evidence-based treatments have been developed and evaluated for borderline personality disorder (BPD), including Dialectical Behavior Therapy (DBT) and Schema Therapy (ST). Individual differences in treatment response to both ST and DBT have been observed across studies, but the factors driving these differences are largely unknown. Understanding which treatment works best for whom and why remain central issues in psychotherapy research. The aim of the present study is to improve treatment response of DBT and ST for BPD patients by a) identifying patient characteristics that predict (differential) treatment response (i.e., treatment selection) and b) understanding how both treatments lead to change (i.e., mechanisms of change). Moreover, the clinical effectiveness and cost-effectiveness of DBT and ST will be evaluated.

The BOOTS trial is a multicenter randomized clinical trial conducted in a routine clinical setting in several outpatient clinics in the Netherlands. We aim to recruit 200 participants, to be randomized to DBT or ST. Patients receive a combined program of individual and group sessions for a maximum duration of 25 months. Data are collected at baseline until three-year follow-up. Candidate predictors of (differential) treatment response have been selected based on the literature, a patient representative of the Borderline Foundation of the Netherlands, and semi-structured interviews among 18 expert clinicians. In addition, BPD-treatment-specific (ST: beliefs and schema modes; DBT: emotion regulation and skills use), BPD-treatment-generic (therapeutic environment characterized by genuineness, safety, and equality), and non-specific (attachment and therapeutic alliance) mechanisms of change are assessed. The primary outcome measure is change in BPD manifestations. Secondary outcome measures include functioning, additional self-reported symptoms, and well-being.

The current study contributes to the optimization of treatments for BPD patients by extending our knowledge on “Which treatment – DBT or ST – works the best for which BPD patient, and why?”, which is likely to yield important benefits for both BPD patients (e.g., prevention of overtreatment and potential harm of treatments) and society (e.g., increased economic productivity of patients and efficient use of treatments).

Trial registration

Netherlands Trial Register, NL7699 , registered 25/04/2019 - retrospectively registered.

Peer Review reports

Borderline personality disorder (BPD) is a complex and severe mental disorder, characterized by a pervasive pattern of instability in emotion regulation, self-image, interpersonal relationships, and impulse control [ 1 , 2 ]. The prevalence in the general population is estimated to be between 1 and 3% [ 3 , 4 , 5 ], and 10 to 25% among psychiatric outpatient and inpatient individuals [ 3 ]. BPD is associated with severe functional impairment, high rates of comorbid mental disorders, and physical health problems [ 5 , 6 , 7 ]. In addition, BPD is characterized by low quality of life; lower compared to other common mental disorders such as depressive disorder, and comparable to that of patients with severe physical conditions, such as Parkinson’s disease and stroke [ 8 ]. Moreover, BPD is related to a high risk of suicide (3–6%, or even up to 10% [ 9 , 10 ]) and suicide attempts or threats (up to 84% [ 11 , 12 ]), and an increased mortality rate [ 13 ]. Besides the detrimental effects of BPD on the individual patient, BPD also poses a high financial burden to society. BPD patients make extensive use of treatment services resulting in markedly higher healthcare costs of people with BPD compared to people with other mental disorders, such as other personality disorders [ 14 ] and depressive disorder [ 15 ]. BPD is also associated with high non-healthcare costs, including costs related to productivity losses, informal care, and out-of-pocket costs [ 16 , 17 ].

Interventions: dialectical behavior therapy and schema therapy

BPD has traditionally been viewed as one of the most difficult mental disorders to treat [ 18 ]. During recent years, a number of promising treatments have been developed and evaluated, including Dialectical Behavior Therapy (DBT) [ 19 , 20 ] and Schema Therapy (ST) [ 21 , 22 ]. DBT is a comprehensive cognitive behavioral treatment for BPD, rooted in behaviorism, Zen and dialectical philosophy [ 19 ]. ST is based on an integrative cognitive therapy, combining cognitive behavior and experiential therapy techniques with concepts derived from developmental theories, including attachment theory, and psychodynamic concepts [ 23 ]. For detailed information about these treatments, the reader is referred to the Methods/design section.

Several studies have demonstrated the effectiveness and the efficacy of DBT and ST for BPD, although the evidence is mostly based on low-to-moderate-quality evidence, and trials focusing on DBT, but especially ST, are limited [ 24 , 25 ]. In addition, substantial reductions in direct and indirect healthcare costs have been found for both treatments [ 26 ]. However, research on the comparative effectiveness and cost-effectiveness of the two interventions is lacking. Moreover, research on mediators and moderators of treatment effects is limited. This gap warrants attention, as treatment effectiveness can be optimized by identifying mechanisms within treatments that are associated with improvement and patient characteristics that predict (differential) treatment response [ 27 ]. Optimizing treatment effectiveness of DBT and ST for BPD is highly needed since a substantial proportion of patients does not respond fully to either DBT or ST. A systematic review found a mean percentage of non-response of 46% among BPD patients treated with specialized psychotherapies, including DBT and ST [ 28 ]. In addition, more than one-third of the patients did not achieve a reliable change in BPD symptoms or even showed an increase in BPD severity after DBT or ST [ 29 , 30 , 31 ]). Finally, dropout rates up to 30% have been found for DBT and ST [ 32 , 33 ]. Individual differences in responses to both ST and DBT have been observed across studies, but the factors driving these differences in treatment response among BPD patients are largely unknown. This state of affairs leaves the principal question “What treatment, by whom, is most effective for this individual with that specific problem, under which set of circumstances?” ([ 34 ], p111), historically one of the key questions dominating the psychotherapy research agenda, fully open in the treatment of BPD individuals [ 35 , 36 ]. Identifying factors that specify which patients will benefit most from which treatment (i.e., treatment selection, or also known as precision medicine or personalized medicine; [ 37 , 38 ]) will lead to fewer mismatches between patients and treatments, and in turn to better outcome and more efficient use of healthcare resources.

• Treatment selection

Several factors predicting treatment response irrespective of type of treatment (i.e., prognostic factors; [ 35 ]) among BPD patients have been reported in the literature. The overwhelming list of candidate variables and the general lack of replication hampers the research among BPD patients on prognostic factors [ 39 ]. Research among BPD patients on prescriptive factors (i.e., factors that predict different outcomes depending on the treatment; moderators) is very scarce indeed. Arntz et al. [ 39 ] examined the effect of several potential predictors of (differential) treatment response across ST and Transference Focused Psychotherapy (TFP) among BPD patients. The authors failed to find prescriptive factors, but it should be noted that the sample size was inadequate to detect subtle differences between treatments. In addition, Verheul et al. [ 40 ] found that patients with a high frequency of self-mutilating behavior before treatment were more likely to benefit from DBT compared to treatment as usual, whereas for patients with a low frequency of self-mutilating behavior effectiveness did not differ.

Historically, research has focused on a single variable to predict treatment response, but often failed to find consistent and clinically meaningful moderators [ 41 , 42 , 43 , 44 ]. However, it is highly unlikely that a single variable is responsible for the differences in treatment response [ 43 , 45 , 46 ]. In recent decades, novel approaches combining multiple predictors to determine the optimal treatment for a particular patient have been introduced, including the methods of Kraemer ([ 47 ]; optimal composite moderator) and DeRubeis and colleagues ([ 35 ]; statistically derived selection algorithm). Several studies have found that a combination of predictors was predictive of differential treatment response (e.g., [ 48 , 49 , 50 ]). For example, by using the method of DeRubeis and colleagues, it was investigated in an effectiveness study among BPD patients which of two different treatments (DBT and General Psychiatric Management; GPM) would have been the optimal treatment option for a particular patient in terms of long term outcome [ 45 ]. The authors found that BPD patients with childhood emotional abuse, social adjustment problems, and dependent personality traits were more likely to benefit from DBT compared to GPM, whereas GPM excelled for patients with more severe problems related to impulsivity. The authors also provided an estimate of the advantage that might be gained if patients had been allocated to the optimal treatment option. The average difference in outcomes between the predicted optimal treatment and non-optimal treatment for all patients was small-to-medium ( d  = 0.36), while the advantage for patients with a relatively stronger prediction increased to a medium-to-large effect ( d  = 0.61). This suggests that treatment allocation based on a treatment selection procedure may substantially improve outcomes for BPD patients.

• Mechanisms of change

Another principal way to improve treatment response is to capitalize on mechanisms underlying change in treatments [ 27 , 45 , 51 , 52 ]. Studying mechanisms of change helps to identify core ingredients of interventions and points the way to enhancing crucial elements, while discarding redundant elements. Presumably, this would maximize (cost-)effectiveness and efficiency as well. Since the 1950s, research on change processes has increased exponentially [ 53 ]. However, the majority of the trials on BPD have focused on outcomes, and only a few addressed how treatments exerted a positive effect on patient outcomes [ 54 , 55 ]. Rudge et al. [ 56 ] reviewed studies on mechanisms of change in DBT. They concluded that there is empirical support for behavioral control, emotion regulation, and skills use as mechanisms underlying change in DBT. Recently, Yakın et al. [ 57 ] examined schema modes as mechanisms of change in ST for cluster C, histrionic, paranoid, and narcissistic personality disorders. They found that a strengthening of a functional schema mode (i.e., healthy adult mode) and weakening of four maladaptive schema modes (i.e., vulnerable child mode, impulsive child mode, avoidant protector mode, and self-aggrandizer mode) predicted improvements in PD symptomatology. However, changes in these schema modes, except for self-aggrandizer mode, also predicted improvements in outcome in treatment-as-usual and clarification-oriented psychotherapy, suggesting that modifying the strength of schema modes might reflect common mechanisms of change. The question of specificity of mechanisms of change is interesting, especially since both DBT and ST have their roots in cognitive behavior therapy and show similarity in certain treatment parameters, but differ substantially in techniques, explanatory model, and terminology [ 58 ]. Clarifying the treatment-specific and non-specific mechanisms of change may be key to furthering the effectiveness of both DBT and ST, and potentially also for psychotherapy in general.

Current study

BPD-tailored treatments, like DBT and ST, are considered treatments of choice for BPD [ 25 ]. However, knowledge on the comparative (cost-)effectiveness of DBT and ST is lacking, as is knowledge on mechanisms of change and patient characteristics that predict (differential) treatment response. We will therefore perform a multicenter randomized clinical trial (RCT) comparing DBT and ST for BPD patients to elucidate the question “Which treatment – DBT or ST – works the best for which BPD patient, and why?”. The main aim of the BOOTS (Borderline Optimal Treatment Selection) study is to improve treatment response of DBT and ST for BPD patients by optimizing treatment selection through the identification of a prediction model based on patient characteristics that predict (differential) treatment response. By doing so, this study is a first step into the development of a treatment selection procedure for BPD patients. Moreover, the results of this study can serve as a starting point for future studies with the ultimate goal of implementing a treatment selection procedure that can be used in clinical practice to guide BPD patients and clinicians in selecting the optimal treatment. In addition, we aim to elucidate the mechanisms by which DBT and ST lead to change, thus pursuing the other main avenue towards improving BPD treatments.

This study has four primary objectives. The first objective of this study is to develop a treatment selection model based on a combination of patient characteristics that predict (differential) treatment response across DBT and ST. Candidate predictors of (differential) treatment response have been selected based on the literature, suggestions of a patient representative of the Borderline Foundation of the Netherlands, and clinicians’ appraisals of BPD patient characteristics that predict (differential) treatment response across DBT and ST. Semi-structured interviews were conducted among 18 expert clinicians to identify patient characteristics they deemed predictive of (differential) treatment response. The extensive investment in the identification of pertinent predictors is a lesson learned from Meehl [ 34 ], who noted that actuarial methods will not outperform clinical judgment when the actuarial method is based on inadequate knowledge of relevant variables. According to Westen and Weinberger [ 59 ], clinical expertise can serve the important function of identifying relevant variables for use in research. In addition, the majority of studies examining predictors of treatment response are based on randomized controlled trials with a primary focus on treatment effectiveness [ 60 ], which could result in the preclusion of potentially relevant predictors due to the lack of instruments assessing these constructs [ 39 , 61 ]. Moreover, findings in the literature may be affected by publication bias, since statistically significant predictors of treatment response are more likely to be published [ 46 ]. Therefore, candidate predictors of (differential) treatment response are not only based on the literature, but also on clinical expertise and experience-based knowledge. We hypothesize that a combination of multiple patient characteristics will predict and moderate treatment effectiveness of DBT and ST. Hypotheses on the effects of single patient characteristics will not be formulated as research among BPD patients often failed to find consistent prognostic factors, while research on prescriptive factors or a combination between factors is scarce. In addition, there was in general a lack of consensus between the 18 expert clinicians on patient characteristics predicting (differential) treatment response across DBT and ST.

Second, we aim to elucidate how DBT and ST exert their effect by gaining a better understanding of the mechanisms of change of DBT and ST. A first step towards more insight into mechanisms of change is the identification of mediators. Mediators are easily confused with mechanisms of change, despite important differences [ 62 ]. A mediator is an intervening variable (partly) accounting for the statistical relationship between the intervention and outcome, and might serve as a statistical proxy for a mechanism of change [ 63 ]. In this study, we will examine potential BPD-treatment-specific, BPD-treatment-generic, and non-specific mediators. Based on empirical research and the presumed mechanisms of change (e.g., [ 55 , 56 , 57 ]), we hypothesize that change in skills use and emotion regulation are the mechanisms underlying change in DBT, and that change in schema modes and beliefs are the mechanisms of change in ST (i.e., BPD-treatment-specific mechanisms of change). In addition, a therapeutic environment characterized by genuineness of the therapists and group members, safety, and equality is considered to be especially important for BPD treatment [ 64 , 65 , 66 , 67 ] and is, therefore, assumed to be a BPD-treatment-generic mechanism of change. Finally, attachment and therapeutic alliance are the presumed non-specific mechanisms of change [ 68 , 69 ].

Third, the comparative effectiveness of DBT and ST will be examined. Accumulating evidence suggests that symptoms and psychosocial functioning are only loosely associated [ 70 , 71 ]. Patients with BPD are characterized by significant impairments in vocational functioning, relationships, and leisure [ 72 ]. In addition, social adjustment of BPD patients is considerably lower than social adjustment seen in other mental disorders, such as major depressive disorder and bipolar I disorder [ 73 ]. Moreover, although several studies found that even as psychopathology after treatment of BPD decreased, impairments in quality of life and functioning often (partly) persist [ 74 , 75 ]. A more comprehensive view of recovery is therefore needed. This notion is underscored by qualitative research that has shown that patients define recovery by personal well-being, social inclusion, and satisfaction with life [ 76 , 77 ]. Therefore, the current trial will track outcomes in multiple domains including symptoms, functioning, and well-being.

Finally, the cost-effectiveness of DBT and ST will be compared. Individual ST seems a cost-effective treatment [ 78 , 79 ]. However, although group ST combined with individual ST is widely used in clinical practice, the cost-effectiveness of this combined program is yet unknown. An international RCT evaluating the (cost-)effectiveness of group ST for BPD is currently in progress [ 80 ]. More economic evaluations of DBT are available and support the cost-effectiveness of DBT. However, the studies vary highly in their design and the number of trials is still somewhat limited [ 26 , 81 , 82 ]. Therefore, an economic evaluation will be performed and a societal perspective will be applied, including indirect and direct healthcare costs.

In addition to these primary objectives, several secondary investigations will be performed, including (but not limited to): 1) the heterogeneity of BPD, 2) substance use (disorders) among patients with BPD, 3) perspectives of patients and therapists in key areas, including predictors, mechanisms of change, the treatments, and the implementation of the results in clinical practice, and 4) psychometric evaluations of several Dutch questionnaires (e.g., Dialectical Behavior Therapy-Ways of Coping Checklist, Ultrashort BPD Checklist).

Methods/design

The study is a multicenter RCT with two active conditions (DBT or ST). The study is set at various Dutch mental healthcare centers accessible through the public health system, including Antes (Rotterdam), GGZ inGeest (Amsterdam), GGZ NHN (Heerhugowaard), GGZ Rivierduinen (Leiden), NPI (Amsterdam), Pro Persona (Ede and Tiel), PsyQ (Rotterdam-Kralingen), and PsyQ/i-psy (Amsterdam). For an overview of the study design, including the enrollment, randomization, interventions, and assessments, see Fig. 1 .

Flow chart of the study design. DBT = Dialectical Behavior Therapy; ST = Schema Therapy. *An extra assessment after wait is included for patients with a waitlist period of more than three months after the baseline assessment

The Medical Ethics Committee of the Academic Medical Center (MEC-AMC) Amsterdam approved the study protocol (registration number NL66731.018.18). The study is registered at the Netherlands Trial Register, part of the Dutch Cochrane Center (registration number NL7699), and complies with the World Health Organization Trial Registration Data Set. Modifications to the protocol require a formal amendment to the protocol which will be examined by the MEC-AMC. The trial adheres to the SPIRIT methodology and guidelines [ 83 ], see Additional file 1 .

Patients are eligible if they 1) are between 18 and 65 years old, 2) have a primary diagnosis of BPD (diagnosed with the Structural Clinical Interview for DSM-5 Personality Disorders; SCID-5-PD), 3) have a BPD severity score > 20 on the Borderline Personality Disorder Severity Index, version 5 (BPDSI-5), 4) have an adequate proficiency in the Dutch language, and 5) are motivated to participate in (group) treatment for a maximum of 25 months and are willing and able to complete the assessments over a period of three years. Patients will be excluded if they 1) fulfill the criteria of a psychotic disorder in the past year (diagnosed with the Structural Clinical Interview for DSM-5 Syndrome Disorders; SCID-5-S), 2) have current substance dependence needing clinical detoxification, 3) have been diagnosed with a bipolar I disorder with at least one manic episode in the past year, 4) have been diagnosed with antisocial personality disorder (diagnosed with the SCID-5-PD), in combination with a history of physical violence against multiple individuals in the past two years, 5) have an IQ below 80, 6) have a travel time to the mental healthcare center longer than 45 min (except when the patient lives in the same city), 7) have no fixed address, and 8) have received ST or DBT in the past year.

Sample size

We aim to include 200 participants. Each center intends to recruit at least 18 patients. For the power analysis, we adopted the minimal statistically detectable effect approach [ 84 ]. A sample size of 200 will be sufficient to have 80% power to detect moderators of treatment effects that have an effect size of Cohen’s f of .20 (small to medium effect size), based on a two-tailed significance level of p  < .05. In addition, the study has 80% power to detect medium effect-sized (i.e., Cohen’s f  = .25) moderators of treatment effects, based on a two-tailed significance level of p  < .01.

Regarding the effectiveness study, with a sample size of N  = 200 the study is powered at 82% to detect a group difference with a medium effect size of Cohen’s d  = .50 at a two-tailed significance level of p  < .05 and assuming a model with center as random effect and an intraclass correlation value of 0.05 corresponding to the center by treatment interaction [ 85 , 86 ].

Finally, a sample size of N  = 200 will be sufficient to have 98% power to detect a medium effect size of the mediation effect ( rr  = .09; [ 87 , 88 , 89 ]), assuming path a (relation between the predictor and mediator) and path b (relation between the mediator and outcome measure) both have a medium effect size ( r  = .30), and based on a simplified trivariate mediation model [ 90 ].

Recruitment

Patients are recruited in the respective participating mental healthcare centers. Patients diagnosed with BPD or for whom this is deemed likely are invited to participate in the screening process. After reading and hearing information about the study and signing an informed consent (see Additional file 2 , Appendix A), patients will start with the screening process. Not only new referrals can be included, but also patients who are already receiving treatment for mental disorders (except patients receiving ST or DBT).

Randomization

A central independent research assistant randomizes the patients per center after a final check of the inclusion and exclusion criteria, and after all baseline measures have been completed. Generally, patients will be randomized using computerized covariate adaptive randomization [ 91 , 92 , 93 ], taking into account gender and severity of BPD (BPDSI-5 score ≤ 24; BPDSI-5 score > 24). By using this method, the imbalance of baseline characteristics between the treatments will be minimized. Patients are allocated to the treatment group that results in the least imbalance between the treatments with an allocation probability of 0.8 to preserve unpredictability [ 94 ]. Groups in both treatments are semi-open which implies that new patients can enter the group if treatment slots are available. Therefore, treatment capacity will be taken into account by using unequal ratios if needed (e.g., 2:1 or 1:3).

In exceptional cases, an alternative randomization method will be used if one or more treatment slots are available in only one condition and there is no available treatment slot in the other condition. To prevent long waiting times for treatment and empty places in the groups, the available treatment slot(s) in one condition will be randomized over 2* k patients whereby k stands for the number of available treatment slots, and randomization is done in the subsample of k patients that wait the longest. Randomization over 2* k patients guarantees unpredictable outcomes. For example, if one treatment slot is available in DBT and there is no available treatment slot in ST at that moment, nor within the foreseeable future, the available treatment slot in DBT will be randomized over two patients waiting for treatment. Sensitivity analyses will be performed by excluding patients that have been randomized using the alternative randomization method.

Procedure and assessments

Patients with BPD or suspected of BPD are invited to the screening process by the research assistant or intake staff member. After providing written informed consent, patients are assessed for eligibility to participate in the study based on the inclusion and exclusion criteria. First, to assess DSM-5 syndrome disorders, the SCID-5-S is administered. The SCID-5-PD will also be administered in case the SCID-5-PD is not part of the standard intake procedure of the mental healthcare center. Second, the BPDSI-5 and a screening interview to assess the motivation and availability of the patient are conducted. A simple “yes” answer to the questions posed by the interviewer (e.g., “Are you motivated and available for treatment, including individual and group sessions?”) is not sufficient. Patients need to elaborate on their answers and follow-up questions are asked if needed. Patients who are eligible for participation will be invited for the baseline assessment, including interviews and computer-based self-report questionnaires, and intake staff members will fill out a questionnaire (i.e., intake questionnaire; see the Measures section) about these patients. After completing the baseline assessment, patients will be randomized as soon as treatment slots become available. Patients will be informed that they have been allocated to one of the treatment conditions, but the name of the treatment will not be communicated to the patient until the first treatment session. If patients cannot be randomized within several months after completing the baseline assessment because of unavailability of treatment slots, the BPDSI-5 will be re-assessed after three months and the BPDSI-5 and cost interview will be re-assessed after six months.

After the treatment phase has started, patients are reassessed every six months during the two years of treatment. These assessments are a combination of interviews and computer-based self-report questionnaires. In addition, a selection of measures are also assessed every three months, by computer-based self-report questionnaires. After end of the treatment, two follow-up assessments (six and 12 months after end of the treatment) will be administered. An overview of the measures is presented in Table 1 . Candidate predictors of (differential) treatment response that are assessed only once at baseline are not included in Table 1 . These measures can be found in the Measures section.

All assessments are performed by trained local research assistants blind to the patients’ treatment condition, with exception of the SCID-5 interviews, demographic interview, and cost interview. The SCID-5 interviews can be administered by trained research assistants as well as trained intake staff members, both blind for condition. The demographic interview and cost interview contain questions on healthcare utilization and are therefore performed by non-blinded local research assistants. Due to the nature of the interventions, blinding of therapists and patients is not possible. All interviews, except for the SCID interviews, are audio-recorded. Participants receive financial compensation for their involvement in the study. Patients who discontinue their treatment or deviate from the treatment protocol will be encouraged to continue the assessments.

For patients of both DBT and ST, treatment has a maximum duration of 25 months and starts with a pretreatment phase of approximately four weeks consisting of several (ST: ± three; DBT: ± five) individual sessions in which patients are prepared for the group sessions and become accustomed to their therapists and the treatment model. After the pretreatment phase, patients receive a combined program of individual sessions and group sessions (i.e., treatment phase). Group sessions of both treatments are offered in a semi-open format. If treatment slots are available, new patients can enter the ST group every 10 weeks and for DBT groups at the start of a mindfulness skills module. In DBT, the treatment phase has a maximum duration of 12 months and consists of weekly group sessions (i.e., skills training groups; 150 min), weekly individual psychotherapy sessions (50 min), and between-session consultation. The between-session consultation, often called telephone consultation although all kinds of technology can be used [ 95 ], is offered to the patient within limitations set by the individual therapist, varying between access to between-session support within working hours to 24/7 access to between-session support, which is officially the standard in DBT. In ST, the treatment phase has a maximum duration of 18 months consisting of weekly group (90 min) and individual (45 min) psychotherapy sessions for a period of 12 months, continued by weekly group psychotherapy sessions and biweekly individual psychotherapy sessions for a period of six months. Following the treatment phase, patients continue their treatment with a maintenance phase. The maintenance phase of DBT is a recently developed blended aftercare program with a maximum duration of 12 months. The blended aftercare program was developed based on results of previous studies (e.g., [ 31 , 96 ]) and recommendations by several authors (e.g., [ 96 , 97 , 98 ]) to extend the duration of DBT to sustain or even enhance treatment effects. The DBT aftercare program consists of monthly individual psychotherapy sessions, three-monthly group sessions, and an eHealth intervention in which patients have online access to DBT handouts and worksheets [ 99 ]. The maintenance phase of ST consists of biweekly individual psychotherapy sessions for a period of three months, continued by three months of one individual session each month. Disregarding the time spent on telephone consultation, homework assignments, and eHealth, and based on 48 working weeks a year, patients will receive about 167 h of treatment if they follow the treatment protocol. Patients who have completed treatment successfully before they reach the maximum number of treatment sessions are allowed to complete treatment earlier, although the assessments will be conducted at the originally planned assessment points. Early termination of treatment requires substantial improvements in the primary and secondary outcomes and is decided in joint decision by the patient and therapist. The treatments are covered by the public health insurance. See Table 2 for an overview of the treatment formats.

Schema therapy (ST)

ST, developed by Jeffrey Young [ 22 , 100 ], is based on an integrative cognitive model, combining cognitive behavior therapy and experiential techniques with insights from developmental theories, including attachment theory, and psychodynamic concepts [ 23 ]. Central concepts are early maladaptive schemas and schema modes. Early maladaptive schemas can be defined as broad, pervasive patterns of thoughts, emotions, memories, and cognitions regarding oneself and relationships with others, developed during childhood [ 22 ]. ST assumes that the frustration of core needs and early traumatic experiences lead to the development of early maladaptive schemas. A schema mode refers to an activated set of schemas and the associated coping response (i.e., overcompensation, avoidance, and surrender), and describes the momentary emotional, cognitive, and behavioral state of the patient. The following schema modes are characteristic of BPD [ 101 ]: 1) vulnerable child mode, associated with a fear of abandonment and strong emotions, such as loneliness, sadness, and helplessness, 2) angry and impulsive child mode, characterized by anger, frustration, hostility, and impulsivity, 3) punitive parent mode, representing the internalized voice of very punitive and critical attachment figures and associated with self-criticism, self-hatred, guilt, and self-denial, 4) detached protector mode, characterized by attempts to cut off the self from needs and feelings, resulting in symptoms of detachment, substance misuse, social withdrawal, and self-harm, and 5) healthy modes, reflecting in functional thoughts, cognitions, and behavior (i.e., healthy adult mode) and the feeling that core needs are been fulfilled (i.e., happy child mode). The first four modes are maladaptive schema modes and central to BPD. The last two modes are functional and often only weakly present at the beginning of the treatment [ 102 ]. Idiosyncratic schema mode models usually cover additional modes, depending on the specific problems and comorbidity of the patient.

ST aims to enable patients to fulfill their needs, reduce maladaptive schema modes, and strengthen adaptive schema modes. In this study, ST is offered in a combined group-individual format developed by Farrell and Shaw [ 103 ]. The group acts as an analogue of a family with the other patients as “siblings” and the two therapists as “parents” [ 103 ]. The group may speed up and amplify the effect of treatment by offering corrective emotional experiences, peer support, opportunities for in vivo practice, and a sense of understanding [ 104 ]. The individual ST follows the protocol as described by Arntz and Van Genderen [ 105 ].

Dialectical behavior therapy (DBT)

DBT is a comprehensive cognitive behaviorally based treatment for BPD, integrating strategies from cognitive and behavioral treatments, Zen-based acceptance strategies, and dialectical strategies [ 19 , 106 ]. Linehan [ 19 , 20 ] proposed a skills deficit model in which emotion regulation is central. More specifically, the model holds that the problematic behaviors associated with BPD (e.g., suicide attempts, self-injury, substance use) are in fact best understood as dysfunctional attempts to regulate emotions. Emotion dysregulation results from the complex transaction between dispositional emotional vulnerabilities and an adverse invalidating environment. Therefore, the treatment involves balancing problem solving strategies with loads of validation. DBT aims to help patients develop new skills, enhance motivation, ensure generalization of skills use, and change their environment if needed. In addition, DBT aims to enhance therapists’ motivation to deliver effective treatment [ 20 ].

DBT involves skills training groups, individual therapy, between-session consultation, and therapist consultation team meetings. DBT skills training groups teach patients behavioral skills in four different, yet inter-related, areas: mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance / radical acceptance. Individual therapy focuses on motivational issues and the acquisition and use of skills in daily life. A predetermined ordering of treatment targets is used in individual sessions and part of different stages of the treatment. Stage 1 focuses on stabilizing the patient and behavior control. Targets in this stage of the treatment include: life-threatening behavior, therapy-interfering behavior, quality-of-life-interfering behavior, and behavior skills. Stage 2 focuses on reducing posttraumatic stress and requires exposure to trauma-related cues [ 19 ]. Finally, Stages 3 and 4 target self-respect and the sense of incompleteness. However, due to time constraints, some patients might not enter all stages and most studies have focused on Stage 1 DBT [ 107 ]. Individual therapists provide between-session (telephone) consultation if needed. According to the guidelines of DBT, access to between-session consultation outside of office hours, preferably by the individual therapist, is part of DBT [ 19 ]. In this trial, between-session consultation by the individual therapist will be within limitations set by the therapist, which can vary between support provided within working hours to 24/7 access to telephone consultation. As access to between-session (telephone) consultation will vary between centers and individual therapists, the effect of therapist’s availability for between-session support will be examined. Finally, DBT therapists meet weekly in a DBT consultation team to motivate and support each other.

Therapists, training, and supervision

The therapists in this study will be licensed psychologists, psychotherapists, psychiatrists, or psychiatric nurses. Individual and group schema therapists must have completed a basic training in individual ST. Group schema therapists must have also completed a four-day training in the group schema therapy model of Farrell and Shaw [ 103 ]. All schema therapists receive a one-day training in experiential techniques by a certified ST trainer. DBT therapists are required to complete a three-day training in DBT and at least one member of the DBT team must have completed the 10-day intensive DBT training. In addition, DBT therapists receive a two-day kick-off training by certified DBT trainers to expand their knowledge of DBT. Moreover, DBT-therapists were given the opportunity to participate in a one-day training in imaginal exposure. According to Linehan [ 19 ], reducing behaviors and stress response patterns related to traumatic life events is a primary DBT target. Reducing posttraumatic stress is mostly part of Stage 2 of DBT and involves exposure to trauma-associated cues [ 19 , 108 ]. However, some of the DBT therapists expressed concerns about their ability to apply the principles and procedures of exposure to treat traumatic memories in BPD patients. Therefore, the opportunity to participate in a one-day exposure training was offered to the therapists.

Before the start of the study, schema therapists should have received at least 10 individual supervision sessions by a licensed supervisor. There is no requirement for the minimum number of DBT supervision sessions. During the study, therapists receive supervision over a period of two years by certified supervisors. ST supervision is provided through teleconferencing biweekly in the beginning, then (two-)monthly after six to 12 months, depending on the experience of the therapists. DBT therapists receive supervision at location every three months. Moreover, there will be weekly DBT team meetings (i.e., DBT consultation team meetings) and biweekly ST team meetings. All individual ST sessions will be audiotaped, while individual DBT sessions and ST and DBT group sessions will be videotaped. These recordings are used for supervision and treatment adherence ratings. Treatment adherence, a component of treatment integrity (i.e., the extent to which a treatment is implemented as intended; [ 109 ]), refers to the extent to which the therapist utilizes prescribed techniques and procedures and avoids the use of proscribed techniques and procedures [ 110 ]. Adherence will be assessed in a random selection of session recordings by trained raters (master psychology students) blind for condition. Master psychology students will be trained by ST and DBT experts by using session recordings not used in the final adherence rating to practice with the instruments. Individual ST sessions will be rated on an adapted version of the Therapy Adherence and Competence scale for ST for BPD [ 111 ] and group ST sessions will be rated on the Group Schema Therapy Rating Scale – Revised [ 112 ]. Individual DBT sessions will be rated on the Dutch translation of the observer-rated version of the DBT Adherence Checklist for Individual Therapy [ 113 ]. An observer-rated instrument will be developed to assess the skills training groups.

Other treatment

During the treatment, patients are not allowed to engage in any other form of psychological treatment. However, in case of acute crisis, the crisis procedures of the treatments will be followed (e.g., telephone consultation by the therapist, contact a crisis line, visit the emergency room, hospitalization, individual crisis management sessions). Any additional treatment will be recorded and included in the analyses. Patients will only be withdrawn from the study at their request.

Coronavirus disease (COVID-19) pandemic

This study is conducted during the COVID-19 pandemic. The pandemic is expected to have adverse effects on patients with mental health disorders [ 114 ]. In addition, in case face-to-face treatment is restricted in mental healthcare centers because of government and healthcare center policy, the treatment will be delivered via videoconferencing. Consequently, differences between patients will arise regarding the amount of treatment sessions delivered during the pandemic and/or via videoconferencing. We will control for a potential influence of the COVID-19 pandemic by, for example, adding dynamic regression parameters that include the impact of time in treatment during the pandemic. The definition of the indicator variable indicating the COVID-19 pandemic will be decided before start of the data-analyses (e.g., dummy variable indicating pandemic/no pandemic or continuous variable indicating the amount of time in treatment during the pandemic), given the unpredictability of the current situation. Moreover, exploratory analyses may be conducted to investigate the potential influence of the deviating treatment format (i.e., online vs. face-to-face individual sessions and/or group sessions) on the treatment effectiveness.

In addition, the assessments will be conducted via videoconferencing or phone, and the computer-based questionnaires will be completed by participants at home, if face-to-face assessments are not allowed. Before receiving the treatment and/or assessments via videoconferencing, patients will sign an additional informed consent form (see Additional file 2 , Appendix B).

Data management, storage, monitoring, and dissemination

Data is collected with a unique identifier for each patient (i.e., pseudonym) using the online survey software program Qualtrics [ 115 ] and the web tool Lotus, which has been especially developed for longitudinal research by the University of Amsterdam. The list of pseudonyms and personal information of patients within a particular mental healthcare center is securely stored at the center and only accessible for the research assistant and coordinator of this center. A different set of pseudonyms is used for data collected by clinicians (i.e., intake questionnaire and recordings). The list with the combination of both pseudonyms of patients is only accessible for the research assistant and coordinator of the center and the authorized researchers. The data is stored on a secure storage server of the University of Amsterdam, accessible only to authorized researchers.

All (serious) adverse events reported by the patient or observed by clinicians or researchers will be recorded. There is no data monitoring committee and the study will not be audited. The results of the study will be disseminated in scientific journals and presentations at (inter)national scientific conferences.

The instruments include screening measures, measures to assess potential predictors and mediators of treatment response, and outcome measures. The instruments that were not available in Dutch were translated (i.e., Brief Experiential Avoidance Questionnaire, Dialectical Behavior Therapy-Ways of Coping Checklist, Gordon Test of Visual Imagery Control, Positive Mental Health scale, and social problems) by bi-lingual experts. The translations were checked for consistency with the original version. Items, questionnaires, and interviews that have been developed or modified by the authors are available upon request by the first author.

Mental disorders

The SCID-5 is a semi-structured interview used to diagnose DSM-5 disorders. Personality disorders are assessed with the SCID-5-PD [ 116 ] and syndrome disorders are assessed using the SCID-5-S [ 117 ], which is an extended version of the SCID-5 Clinician Version (SCID-5-CV; [ 118 ]). Additional file 3 offers an overview of all syndrome disorders that are assessed by the SCID-5-S. Based on a first psychometric evaluation in a psychiatric patient sample, Somma et al. [ 119 ] found an adequate interrater reliability of the SCID-5-PD. In addition, the SCID-5-CV has demonstrated good psychometric properties [ 120 , 121 , 122 ].

Before administering the SCID-5-S and/or SCID-5-PD, self-report screening questionnaires (SCID-5-SPQ; [ 123 ], and SCID-5-SV; [ 124 ]) may be administered. In accordance with the instructions for administering the SCID, disorders and criteria of disorders not affirmed by the screening questionnaires and not considered as false negatives by the clinician will be assumed to be absent. The SCID-5 will be assessed during the screening phase and 12 months after end of the treatment.

Motivation and availability

A 13-item semi-structured motivation interview is used to assess several exclusion criteria (e.g., no fixed address, have received ST or DBT in the past year) and patient’s motivation and availability.

As mentioned, candidate predictor variables of (differential) treatment response have been selected using a multi-method approach (i.e., literature, suggestions of a patient representative of the Borderline Foundation of the Netherlands, and semi-structured interviews with 18 expert clinicians). Additional file 4 , Table 1 offers an overview of the predictors that have emerged during the semi-structured interviews with clinicians. Additional file 4 , Table 2 offers an overview of the predictors based on the literature and suggestions of a patient representative. The candidate predictors of (differential) treatment response are assessed at baseline. Only the measures that are not part of the screening, mediator or outcome measures will be briefly described in this paragraph.

Autistic traits

Autistic traits are assessed by the abbreviated version of the Autism Spectrum Quotient, the AQ-10 [ 125 ]. The AQ-10 consists of 10 items rated on a four point Likert scale. The AQ-10 has demonstrated acceptable psychometric properties in an adult general population sample [ 126 ].

Patient commitment to treatment is measured with a selection of items of the subscale Motivation to Engage of the Treatment Motivation Scales for forensic outpatient treatment (TMS-F; [ 127 ]). The four items can be rated on a seven point Likert scale.

Experiential avoidance

The Brief Experiential Avoidance Questionnaire (BEAQ; [ 128 ]) is a 15-item scale assessing experiential avoidance across six domains (i.e., behavioral avoidance, distress aversion, suppression, procrastination, repression/denial, and distress endurance). The items can be rated on a six point Likert scale. The BEAQ has shown good psychometric properties among psychiatric outpatients [ 128 ].

Frustration intolerance

Frustration intolerance is assessed by the Frustration Tolerance subscale of the Severity Indices of Personality Problems (SIPP-118; [ 129 ]). This subscale consists of eight 4-point Likert scale items measuring the capacity to cope with setbacks and disappointments. In previous research among Dutch patients with a personality disorder, the subscale demonstrated moderate to good reliability [ 129 ].

A modified version of the Self-Reflection and Insight Scale (SRIS; [ 130 , 131 ]) is used to assess self-reflection and insight. The SRIS contains 20 five point Likert scale items. The SRIS has shown good reliability and validity in student samples [ 130 , 132 ].

Internal locus of control

Internal locus of control, defined as the extent to which a person experiences an outcome as the result of their own behavior or personal characteristics rather than external circumstance, is assessed by the Locus of Control scale (IE; [ 133 ]). The IE contains 10 five point Likert scale items. Previous research has demonstrated adequate psychometric properties [ 133 , 134 ].

Level of personality functioning

The Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF 2.0; [ 135 ]) assesses impairment in personality functioning according to the DSM-5 alternative model for personality disorders. The LPFS-BF 2.0 contains 12 four point Likert scale items. Based on a first psychometric evaluation among Dutch patients referred to a specialized mental healthcare center for personality disorders, the LPFS-BF 2.0 has demonstrated satisfactory psychometric properties [ 135 ].

Mental imagery capacity

Mental imagery capacity is assessed with the 12-item Gordon Test of Visual Imagery Control (TVIC; [ 136 ]). The TVIC assesses the ability to visualize and manipulate a given scenario in response to a set of cues. Participants can response on a three point Likert scale. In addition to the 12 Likert scale items, we measure the time it takes the participant to visualize the scenarios. Finally, we have added two 100 mm visual analog scale (VAS) items measuring how well participants see the scenarios that were described and how difficult it was for the participant to visualize the different scenarios. The TVIC has demonstrated fair to satisfactory internal consistency and validity among community samples and undergraduates [ 137 , 138 , 139 , 140 ].

Mentalizing capacity

Mentalizing capacity is measured using an eight-item version of the Reflective Functioning Questionnaire (RFQ-8; [ 141 ]). The RFQ-8 comprises two dimensions: uncertainty about mental states, reflecting hypomentalizing, and certainty about mental states, indicating hypermentalizing. The RFQ-8 uses a seven point Likert scale. In previous research among BPD patients, the questionnaire has demonstrated satisfactory psychometric properties [ 141 , 142 , 143 ].

Perfectionism

The eight-item Frost Multidimensional Perfectionism Scale-Brief (F-MPS-Brief; [ 144 ]) assesses perfectionism across two dimensions (evaluative concerns and striving). Items are rated on a five point Likert scale. Psychometric properties of the F-MPS-Brief were found to be good in clinical and community samples [ 144 ].

Personality traits

Personality traits are measured, among others, with the Ten-Item Personality Inventory (TIPI; [ 145 , 146 ]), which is a brief measure of the Big-Five personality dimensions. The 10 items can be rated on a seven point Likert scale. The TIPI has shown low to moderate internal consistency and adequate validity among students [ 145 , 146 ].

Positive mental health

Positive mental health, often referred to as mental well-being, is assessed using the nine-item Positive Mental Health scale (PMH-scale; [ 147 ]). The items can be rated on a nine point Likert scale. Based on a previous study on the psychometric properties of the PMH-scale in student, patient and general samples, the PMH-scale was found to be a reliable and valid instrument [ 147 ].

Psychopathology and maladaptive personality traits

The Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF; [ 148 ]) measures a wide range of psychopathology symptoms, personality characteristics, and behavioral proclivities. The MMPI-2-RF consists of 338 true-false items aggregating onto 51 individual scales. The psychometric properties of the MMPI-2-RF varied from inadequate to good among normative, outpatient, and inpatients samples, as documented in detail in the Technical Manual [ 149 ].

Readiness to change

Readiness to change is assessed by two subscales (contemplation and action) of the 24-item version of the University of Rhode Island Change Assessment (URICA; [ 150 , 151 , 152 ]). Both subscales are measured by six 5-point Likert scale items and have demonstrated good reliability across a diversity of studies (e.g., [ 153 , 154 , 155 ]).

Rigidity is measured by the Rigidity subscale of the Computerized Adaptive Test of Personality Disorder-Static Form (CAT-PD-SF; [ 156 ]). The Rigidity subscale contains 10 five point Likert scale items reflecting an unwillingness to consider alternative perspectives and inflexibility in values and beliefs. The subscale has demonstrated good reliability among community adults with current or a history of mental health treatment [ 156 ].

Social problems

By using the social problems list, derived from the Improving Access to Psychological Therapies (IAPT) program [ 157 ], social problems (e.g., financial problems, housing problem, and unemployment) are assessed in direct discussion with the patient.

Social support

The Multidimensional Scale of Perceived Social Support (MSPSS; [ 158 ]) is assessed to investigate perceived support from three sources: significant others, family, and friends. The MSPSS contains 12 items which can be rated on a seven point Likert scale. Psychometric properties of the MSPSS are satisfactory among psychiatric outpatients and BPD patients [ 159 , 160 ]. In addition to the MSPSS, the research assistant rates the patient’s social network taking into account the size of the network and potential pathogenic influences.

Stigma of immutability

BPD has been associated to stigma of immutability [ 161 ]. We have developed five 7-point Likert scale items assessing the extent to which participants believe that BPD is resistant to treatment.

The Traumatic Experience Checklist (TEC; [ 162 ]) is used to assess traumatic experiences, including emotional abuse, emotional neglect, sexual abuse, sexual harassment, physical abuse, and threat to life/ bizarre punishment/ intense pain. The TEC includes 30 descriptions of various traumatic experiences. The TEC has demonstrated favorable psychometric properties in Dutch psychiatric patients [ 162 ].

Verbal intelligence

The Dutch version of the National Adult Reading Test (DART; [ 163 ]) is used as a proxy for verbal intelligence. The DART is a reading test including 50 irregularly spelled words. Based on previous research, the DART yields an adequate estimation of verbal intelligence and has shown adequate psychometric properties across a variety of populations [ 164 ].

Other patient characteristics, collected using a self-report questionnaire

In addition to the questionnaires, participants fill out several questions developed by the authors about the willingness and ability to engage in a therapeutic relationship, perceived suitability of DBT and ST (treatment preference), and the absence or presence of an attachment figure in the past.

Other patient characteristics, collected using a questionnaire filled out by clinicians (intake questionnaire)

Clinicians responsible for the intake assessment will fill out the nine-item intake questionnaire for each participant, including questions about the willingness and ability to engage in a therapeutic relationship, the willingness and ability to examine the link between childhood history and present problems, high vs. low level borderline personality organization [ 165 ], the request for help, the degree to which a syndrome disorder might interfere with treatment response, and perceived suitability of DBT and ST. These questions have been formulated by the authors.

Both treatments include non-specific (attachment and therapeutic alliance), BPD-treatment-generic (therapeutic environment characterized by genuineness, safety, and equality), and BPD-treatment-specific (ST: beliefs and schema modes; DBT: emotion regulation and skills use) mechanisms of change. The proposed mediators are repeatedly measured: at baseline, except for measures requiring information about the therapy (i.e., therapeutic environment, therapeutic alliance, and attachment styles with respect to the most important therapist and group members), and every six months after start of the treatment phase. In addition, a selection of the proposed mediators (i.e., selection of schema modes, skills use, beliefs, and therapeutic environment) are also collected every three months after start of the treatment phase, during the first two years.

The Experience in Close Relationships-Relationship Structures Questionnaire (ECR-RS; [ 166 ]) is a brief version of the Experience in Close Relationships-Revised (ECR-R; [ 167 ]). The ECR-RS measures attachment patterns in different relational domains, such as relationships with parents and friends. The ECR-RS can also be adapted to measure a person’s general attachment style. In this study, three versions of the ECR-RS are used, measuring general attachment style and attachment styles with respect to two targets (i.e., most important therapist and group members). The ECR-RS contains nine items, assessing two attachment dimensions: attachment-related anxiety and avoidance. The items can be rated on a seven point Likert scale. The ECR-RS has shown adequate psychometric properties in a large web-based sample ( N  > 21.000), comparable to the ECR-R [ 166 ]. As experience with the treatment is required in order to be able to complete the questions about the most important therapist and group members, these questions will be filled out three weeks after start of the treatment phase.

Idiosyncratic dysfunctional beliefs were elicited with a semi-structured interview at baseline. Three to five idiosyncratic dysfunctional beliefs related to the self (e.g., “I am worthless”), others (e.g., “People always reject me”), and emotions (e.g., “Expressing emotions is a sign of weakness”) are formulated. Participants rate the degree to which they believe in each statement on a 100 mm VAS at baseline and at every subsequent assessment. This procedure has been used in previous research (e.g., [ 168 , 169 ]). The VAS has found to be useful for assessing variations in intensity of beliefs in patients with a personality disorder [ 169 ]. In addition to the idiosyncratic dysfunctional beliefs, participants rate the credibility of one functional belief (“I consider myself a good person”) on a 100 mm VAS.

Emotion regulation

Emotion regulation is assessed by the Difficulties in Emotion Regulation Scale Short Form (DERS-SF; [ 170 ]), a brief version of the widely used DERS [ 171 ]. The DERS-SF measures non-acceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to emotion regulation strategies, lack of emotional clarity, and lack of emotional awareness. The awareness subscale is excluded based on recommendations of among others Hallion et al. [ 172 ] and Bardeen et al. [ 173 ]. Lack of emotional awareness is assessed by the Awareness subscale of the Difficulties in Emotion Regulation Scale 18 (DERS-18; [ 174 ]). The DERS-SF, without the awareness subscale, consists of 15 items. The Awareness subscale of the DERS-18 is measured by three items. All items can be rated on a five point Likert scale. Both questionnaires have demonstrated good psychometric properties among outpatients [ 172 ].

Schema mode ratings

The Schema Mode Inventory (SMI; [ 175 ]) measures the extent to which 16 different (dysfunctional as well as functional) schema modes are endorsed. The SMI consists of 143 items that are scored on a six point Likert scale. Previous research using a sample of non-patients and patients with a syndrome disorder and/or personality disorder has demonstrated acceptable psychometric properties [ 176 ]. The five maladaptive schema modes that are central to BPD (i.e., vulnerable child, angry child, impulsive child, detached protector, and punitive parent; [ 101 ]) and one functional schema mode (i.e., healthy adult) are assessed every three months during the first two years.

The 59-item Dialectical Behavior Therapy-Ways of Coping Checklist (DBT-WCCL; [ 177 ]) is an adaptation of the Revised Ways of Coping Checklist (RWCCL; [ 178 ]). The DBT-WCCL measures DBT skills use and maladaptive coping skills use over the previous month. All items are assessed using a four point Likert scale. The DBT-WCCL has shown adequate to excellent reliability and validity among BPD patients [ 177 ].

Therapeutic alliance

The therapeutic alliance is measured with the Working Alliance Inventory-Short (WAI-S; [ 179 , 180 ]). The WAI-S consists of three subscales (agreement on goals, agreement on tasks, and bond between patient and therapist), each consisting of four items which can be scored on a five point Likert scale. Observed psychometric properties of the WAI-S were satisfactory in a patient sample [ 179 , 181 ]. Since experience with the treatment is required in order to be able to complete the WAI-S, the WAI-S will be filled out three weeks after start of the treatment phase.

Therapeutic environment

Key characteristics of a promoting therapeutic environment (i.e., genuineness, safety, and equality) are assessed by 13 items formulated by ST experts (A. Arntz and O. Brand-de Wilde) and rated on a 100 mm VAS. The items measure the extent to which the participant feels a) the individual therapist, group therapists, and group members are genuine with him/her; b) he or she can tell the individual therapist and group therapists everything; c) safe in the individual and group therapy; d) safe to show vulnerability and express negative feelings in the individual and group therapy; e) the individual and group therapists take personal responsibility for their mistakes; and f) the individual and group therapists see him/her as equal. Since experience with the treatment is required in order to be able to complete this questionnaire, this questionnaire will not be assessed at baseline.

Primary outcome

Bpd severity.

The primary outcome measure is the change in severity and frequency of the DSM-5 BPD manifestations between baseline until three-year follow-up, assessed with the total score of the Borderline Personality Disorder Severity Index version 5 (BPDSI-5; [ 182 , 183 ]). The BPDSI-5 is a semi-structured interview consisting of 70 items rating the nine DSM-5 BPD criteria over the prior three months. All items are rated on a 11-point Likert scale (0 = never to 10 = daily), except for the subscale Identity Disturbance which is rated on a 5-point Likert Scale (0 = absent to 4 = dominant, clear, and well-defined) and multiplied by 2.5. The total score consists of the sum of the nine criteria scores and ranges from 0 to 90. The scores on the BPDSI-5 subscales provide information on the severity of each of the nine criteria. The BPDSI-5 is a modified version of the BPDSI-IV [ 182 , 183 ] in which a few questions have been slightly reworded and exact frequency scores have been added in addition to the Likert scale. The BPDSI-IV has proven to be a reliable and valid measure among non-patients and (BPD) patients [ 182 , 183 ]. Previous research has shown that a cut-off score of 15 differentiates between BPD patients and controls [ 183 ]. In addition, a score of 20 distinguishes BPD patients from non-BPD patients [ 183 , 184 , 185 ].

Secondary outcome measures

As accumulating evidence suggests that BPD severity and level of functioning are only loosely associated, attention will be paid to outcomes in different areas, including symptoms, functioning, and well-being. The outcome measures are administered at baseline and every six months after start of the treatment phase. In addition, patients’ ratings of experienced burden due to BPD manifestations and well-being are collected every three months after start of the treatment phase, during the first two years.

Costs, including healthcare costs, patient and family costs, and costs outside the healthcare sector, are measured using a retrospective cost interview especially designed for BPD patients [ 80 ]. Healthcare costs include visits to general practitioners, hospitals, crisis centers, psychologists and psychiatrists, use of medication, social work, paramedical care, and alternative treatments. Patient and family costs include informal care (i.e., care provided by the patient’s family, friends, or neighbors) and out of pocket costs (e.g., drugs, alcohol, excessive spending). Costs in other sectors include productivity losses from unpaid work (study and voluntary work) and paid work. Since it is difficult to distinguish between BPD-related costs and costs due to other psychological disorders [ 17 ], only a distinction will be made between costs due to psychological disorders and costs due to somatic diseases. The cost interview will be conducted by trained research assistants using a recall period of six months (baseline assessment), the number of weeks since randomization (assessment six months after start of the treatment phase), or the number of weeks since the previous assessment (assessments 12, 18, and 24 months after start of the treatment phase and both follow-up assessments).

Dutch guidelines [ 186 , 187 ] will be used to determine total costs. Healthcare costs will be calculated by volumes of resource use multiplied by their corresponding unit costs, derived from Hakkaart-van Roijen et al. [ 186 ]. Prescribed medication costs will be determined based on national reference prices. Informal care costs will be computed by multiplying the number of hours the patient receives informal care by shadow prices [ 186 ]. Shadow prices will also be used to value lost productivity in study and voluntary work. Productivity losses from paid work will be valued according to the Human Capital Approach [ 188 ]. Out of pocket costs, such as alcohol and excessive spending, will be directly retrieved from the cost interview or, in case of over-the-counter medication, from the Dutch Pharmacotherapeutic Compass [ 186 ].

Demographics

General patient characteristics (e.g., age, ethnicity, marital status, educational level, employment status) will be collected using a semi-structured demographic interview. During this interview, additional patient characteristics such as treatment history, request for help, medication use, substance use, and duration of BPD manifestations will be recorded. For an overview of all characteristics, see Additional file 4 .

Experienced burden due to BPD

Patient’s self-reported experienced burden of BPD manifestations are measured using the Ultrashort BPD Checklist, a shortened version of the validated BPD Checklist [ 189 ]. The Ultrashort BPD Checklist consists of nine to 11 5-point Likert scale items (the number of items will be based on the upcoming validation study), each related to a specific DSM-5 BPD criterion. Based on an initial psychometric evaluation, the Ultrashort BPD Checklist showed good to excellent psychometric properties in a sample with BPD and cluster C patients, patients with a syndrome disorder, and non-patients, similar to the BPD Checklist [ 189 ].

General psychopathological symptoms

The Brief Symptom Inventory (BSI; [ 190 , 191 ]) is a self-report instrument measuring general psychiatric symptoms at the time of assessment. The BSI is a short version of the Symptom-Check-List (SCL-90-R) and contains 53 items assessing nine symptom dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. All items are assessed using a five point Likert scale. Previous research in Dutch community and patient samples has demonstrated good reliability and validity [ 191 , 192 ].

Global functioning and impairment

Global functioning and impairment is assessed by the 36-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) interview version [ 193 ]. The WHODAS 2.0 is a general measure to assess disability in six major life domains (cognition, mobility, self-care, getting along, life activities, and participation). For each item, participants have to report how much difficulty they experienced in the last 30 days. The six domain scores and overall functioning score have shown good psychometric properties in a general population sample as well as a patient sample [ 193 ].

Quality of life

Generic quality of life is assessed using the 5-level EuroQol 5D version (EQ-5D-5L; [ 194 ]). The questionnaire measures five health state dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is divided into five severity levels: no problem, slight problems, moderate problems, severe problems, and extreme problems. The profiles from the five health state dimensions are assigned a value based on the Dutch social tariffs to generate health utilities [ 195 ]. These utilities will be used to calculate Quality Adjusted Life Years (QALYs) by multiplying the change in utility values between assessments by the length of the period between assessments. In addition to the five health state dimensions, the EQ-5D-5L contains a VAS item which records the patient’s self-reported health status ranging from 0 (worst health you can imagine) to 100 (best health you can imagine). The EQ-5D-5L has shown to be a reliable and valid measure among different patient groups in different countries [ 196 ].

As a complement to the EQ-5D-5L, the Mental Health Quality of Life seven-dimensional Questionnaire (MHQoL-7D; [ 197 ]) will be administered. The MHQoL-7D is a recently developed instrument to assess quality of life specifically in people with mental health problems. The MHQoL-7D consists of seven quality of life domains (self-image, independence, mood, relationships, daily activities, physical health, and hope) and a VAS item which records the patient’s self-reported psychological well-being. A study into the psychometric properties of the MHQoL-7D is currently running. The MHQoL-7D will only be included in the analysis if it is demonstrated to be a psychometrically sound instrument and Dutch social tariffs are available.

Insomnia complaints are assessed by the Insomnia Severity Index (ISI; [ 198 ]). The ISI contains seven items that are scored on a five point Likert scale. The ISI has shown to be a valid measure in community and insomnia patient samples [ 198 ], although the reliability was questionable in some studies (e.g., [ 199 , 200 ]). In addition to insomnia, the number of nights with nightmares and the total number of nightmares in the week prior to the assessment are measured using the Nightmare Frequency Questionnaire (NFQ; [ 201 ]). Based on previous research among posttraumatic stress disorder (PTSD) patients, the NFQ appears reliable for measuring nightmare frequency [ 201 ].

Well-being is measured using a single item measuring happiness [ 202 ] and the Outcome Rating Scale (ORS; [ 203 ]). The single item measures general happiness in the months prior to the assessment on a seven point Likert scale. Reliability and validity were good among undergraduates [ 202 ], and sensitivity to change was excellent in a BPD sample [ 184 ]. The ORS consists of four VAS items assessing four areas of functioning: individual (personal well-being), interpersonal (family and close relationships), social (work and/or school functioning), and overall (general sense of well-being). We slightly adapted the third dimension of the ORS by excluding friendships, because of its overlap with the second dimension (interpersonal functioning). Hafkenscheid et al. [ 204 ] reported adequate psychometric properties of the ORS is a Dutch outpatient sample.

Statistical analyses

The statistical analyses for the (cost-)effectiveness, mechanisms of change and treatment selection studies are under development. For example, according to Cohen et al. [ 48 ], the treatment selection field is still in its developmental stage and statistical methods are constantly evolving. Recently, great efforts have been made by several authors (e.g., [ 205 , 206 ]) to select the optimal prediction model by comparing different variable selection techniques. Considering the ongoing advances in methodological approaches, the statistical analyses described below should be considered as examples of appropriate analytic methods. We will determine the optimal methods at the time of the analyses. An update of the protocol will be published, including the selected statistical methods, before start of the data-analyses. The statistical analyses will be performed according to the intention-to-treat (ITT) principle (i.e., including all patients that have been randomized and received at least one treatment session). In addition to the primary analysis based on the ITT principle, a completers analysis will be conducted by excluding patients who dropped out prematurely (i.e., termination of the treatment before planned end, without patient and therapist agreeing that enough improvement has been reached to justify the termination) or deviated from the protocol (e.g., sought other psychological treatment in addition to the study treatment). No interim analyses are planned.

A two-step approach will be applied to determine the optimal treatment for a particular patient by identifying patient characteristics that predict (differential) treatment response. First, we will examine which of the candidate predictors (see Additional file 4 for an overview) predict (differential) treatment response. Many different variable selection approaches can be used to identify which of the candidate predictors contribute to the prediction of treatment outcome, for example elastic net regularization [ 207 ], Bayesian additive regression trees [ 208 ], or a combination between different variables selection procedures [ 48 ]. Second, individual treatment recommendations are generated based on a prediction model including the variables that predict (differential) treatment response. For each patient, the most beneficial treatment will be identified by using the prediction model to estimate the predicted outcomes for both treatments including the difference in predicted outcomes.

Our primary analysis will focus on individual treatment recommendations based on change in BPD manifestations and will therefore reveal the advantage in symptom relief that may be gained if patients are allocated to their predicted optimal treatment compared to their predicted non-optimal treatment. To investigate the advantage that may be gained in other outcomes, such as functioning and cost-effectiveness, generalization analyses will be performed by testing the performance of the prediction model for these outcomes.

It is hypothesized that the treatments exert a remedial effect on the frequency and severity of BPD manifestations by their impact on the BPD-treatment-specific (ST: beliefs and schema modes; DBT: emotion regulation and skills use), BPD-treatment-generic (therapeutic environment characterized by genuineness, safety, and equality), and non-specific (attachment and therapeutic alliance) mechanisms of change. Since potential mediators and outcome will be assessed multiple times, temporal patterns of change can be studied by performing mediation analysis for longitudinal data, for example multilevel autoregressive mediation analysis [ 209 ] or multilevel structural equation modeling [ 210 ]. By using advanced statistical models, the hierarchical structure of the data (repeated measures nested within patients, who in turn are nested within centers) can be taken into account and possible concurrent and temporal relations between mediators and outcome can be investigated.

Clinical effectiveness

Change in the outcome measures and the relative effectiveness of the two treatment conditions will be analyzed using mixed regression so that all available data are used, and taking into account the dependencies among observations nested within individuals nested within centers. Potential center effects are modeled by including a random effect which enables generalization of results outside the trial and maximizes statistical power [ 211 ]. Since group sessions in both treatments are offered in a semi-open format, patients will start with group treatment at different time points. One can imagine that patients starting treatment at the same time point are more interdependent compared to patients starting treatment at different time points. Therefore, we will take into account, if needed, the interdependency of patients. The underlying distributions of the mixed regression models will be determined based on the variable type (i.e., scale or nominal) and the distribution of residuals (e.g., normal, gamma, negative binomial).

Cost-effectiveness

The cost-effectiveness evaluation will be performed from a societal perspective and includes a cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). The primary clinical outcome for the CEA will be the severity of the BPD manifestations and for the CUA utility scores will be derived from the quality of life instrument(s), both with a time horizon of 12 months after the end of treatment. The net benefit will be used to express cost-effectiveness. For each patient, the net benefit will be calculated by subtracting the costs incurred by the patient from the amount that the society is willing to pay for the health benefit [ 212 ]. The development of the net benefit over time and differences between the treatments will be modeled using multilevel modeling in which the hierarchical structure of the data and potential missing values are taken into account. The best fitting model to describe the development over time and the appropriate distribution of the net benefit data (e.g., gamma distribution, log-normal distribution) will be based on the data. Cost-effectiveness acceptability curves (CEACs) will be drawn showing the probability that one treatment is more cost-effective compared to the other treatment, given the observed data, for a range of willingness-to-pay values. Sensitivity analyses will be performed to address the uncertainties in methodology and assumptions and to test for the robustness of findings.

Additional substudies

Several secondary studies will be conducted, including, but not limited to, the investigation of the heterogeneity of BPD and substance abuse among BPD patients, a qualitative study into the perspectives of patients and therapists, and psychometric evaluations. First, BPD is characterized by considerable heterogeneity [ 165 , 213 ]. Over the past years, researchers have attempted to identify BPD subtypes based on different indicator variables (e.g., DSM-5 criteria, interpersonal characteristics, temperament) and different statistical strategies (e.g., exploratory factor analysis, Q-factor analysis, finite mixture modeling) [ 214 ]. The BPD subtypes that emerged differed substantially between studies. According to Hallquist and Pilkonis [ 214 ], advances in classifying BPD subtypes can be made by using a theoretical model as guidance, for example Kernberg’s theory [ 215 ]. Therefore, a substudy into the heterogeneity of BPD will be performed based on theoretically justified indicators and state-of-the-art statistical methods.

A second substudy will focus on the co-occurrence of substance abuse and BPD. Research suggests that patients with BPD and substance abuse have more severe problems, including higher rates of suicide attempts, more treatment noncompliance, and increased risk of violence, compared to BPD patients without substance abuse (e.g., [ 216 , 217 , 218 ]). However, few trials have assessed the effectiveness of treatments for BPD patients with substance abuse. In addition, research into the effect of BPD treatment on substance abuse is also limited [ 219 ]. Third, qualitative research will be conducted to explore the perspectives of patients and therapists in key areas, including predictors, mechanisms of change, the treatments, and the implementation of the results in clinical practice. Finally, psychometric evaluations of several Dutch questionnaires (e.g., Dialectical Behavior Therapy-Ways of Coping Checklist, Ultrashort BPD Checklist) will be performed.

This article described the study protocol of a multicenter RCT focusing on the (differential) treatment effectiveness of DBT and ST for patients with BPD. The primary aim of the study is to improve treatment outcome of DBT and ST for BPD patients by optimizing treatment selection through identifying patient characteristics that specify which patients will benefit most from which treatment. In addition, we aim to elucidate the change mechanisms of DBT and ST, which is crucial for improving treatments and, in turn, treatment response [ 51 , 52 , 220 ]. Finally, the comparative effectiveness and cost-effectiveness of DBT and ST will be compared.

This trial provides a unique opportunity to gain more insight into one of the main questions dominating the psychotherapy research agenda: “What works for whom and why?”. Although DBT and ST share some important characteristics, different interventions related to different assumed core deficits in BPD are provided [ 58 ]. As each treatment provides a different therapeutic milieu and focuses on different goals and tasks, a particular treatment may be a better fit with some patients compared to others [ 45 ]. In this study, patient characteristics of (differential) treatment response will be identified and individual treatment recommendations (DBT or ST) will be generated. In addition, for each patient, an estimate will be provided of the potential advantage in symptom relief that might be gained in case the patient was allocated to his or her indicated treatment. Moreover, the potential advantage in other outcomes, for example functioning and cost-effectiveness, will also be estimated. Knowing which treatment is most cost-effective for whom may lead to more efficient allocation of healthcare resources, which is important, as the current healthcare system is characterized by constraints in resources (e.g., people, time, budget; [ 221 ]). However, before a treatment selection procedure can be implemented in clinical practice, replication and external validation of the prediction model is needed. Subsequently, a prospective study in which the patient and clinician collaborate in selecting the optimal treatment (i.e., shared decision making; [ 222 ]), guided by treatment recommendations based on the prediction model, should be conducted to evaluate the advantage of a treatment selection procedure. By using a state-of-the-art approach, the results of the current study can serve as the starting point for future studies into personalized medicine among BPD patients, and is therefore of great importance.

In addition, this trial provides insight into the comparative (cost-)effectiveness of DBT and ST. Although the effectiveness of both treatments has been established, DBT and ST have not been directly compared. Therefore, and because outcome measures differ substantially between studies on the effectiveness of DBT or ST, hypotheses concerning the differential effectiveness can hardly be formulated. According to the “Dodo Bird effect” [ 223 , 224 ], all evidence-based psychotherapies are equally effective, suggesting that DBT and ST will produce equivalent outcomes. However, a meta-analysis into the comparative effectiveness of evidence-based treatments for personality disorders demonstrated that some treatments may be more effective than others [ 225 ]. In addition, Fassbinder et al. [ 226 ] hypothesized that ST may be more effective than DBT in reducing psychiatric comorbidity and improving quality of life, while DBT may lead to a better and faster reduction in self-harming and suicidal behaviors. Moreover, although not assessed in direct comparison with ST, the meta-analysis of Storebø et al. [ 25 ] into psychological treatments for BPD indicated that DBT may be especially effective for BPD-severity, self-harm, and psychosocial functioning. They also pointed out that more research into the effects of BPD-tailored treatments, including head-to-head comparisons, is needed. By focusing on an array of outcomes, this study will extend our knowledge on the potential differential effects of DBT and ST.

This study has several strengths. First, this RCT is quite inclusive in terms of patient characteristics, and as such designed to reflect clinical practice to enhance ecological validity. Second, this trial is conducted by a research group including researchers with balanced allegiance to either ST or DBT and an independent researcher (i.e., C.J.M. Wibbelink), to prevent the potential effect of research allegiance on treatment outcomes [ 227 ]. Third, we adopt a broad view on treatment response by including outcome measures reflecting different areas of recovery (e.g., BPD symptoms, functioning, well-being). Focusing on outcomes beyond symptom reduction is in line with patients’ view on recovery [ 76 , 77 ]. In addition, it follows a multi-method assessment approach, as the outcome measures include both self-report questionnaires and semi-structured interviews. Fourth, we include a large amount and broad range of patient characteristics potentially predictive of (differential) treatment response across DBT and ST. Finally, the presumed mediators and outcomes will be frequently measured on multiple time points during the treatments and mediation analyses will be performed by using state-of-the-art statistical analysis methods [ 228 ]. This allows us to establish concurrent as well as temporal relationships between the mediators and outcomes [ 228 ]. However, according to Lemmens et al. [ 229 ], understanding psychotherapeutic change may be too challenging, even in optimal research designs. Psychotherapy consists of a complex interplay of multiple mechanisms on different levels. Finding that a construct (e.g., therapeutic alliance) mediates treatment outcome does not explain how changes in this construct lead to changes in the outcome as it could involve several processes (e.g., cognitions, behaviors, emotions, neural systems) [ 63 ]. It is therefore highly questionable if these complex processes can be assessed by relatively simple mediational models. As such, this is one of the potential limitations of the current study.

This study has several other limitations that should be considered when evaluating the results. First, as power is conventionally set a 80% [ 84 , 230 , 231 , 232 ], we used a minimum criterion of 80% power for the power analyses. However, this means that we accept a 20% chance of a false negative result. Second, since DBT and ST are both evidence-based treatments for BPD, differential effects in treatment outcome may be small or non-existing. To demonstrate equivalence or small effects between treatments, a very large sample size is needed. The sample size of the current study is not large enough (i.e., does not have ≥80% power) to reliably detect a small differential treatment effect. However, the comparison of treatments is not the main aim of the study. In addition, according to Luedtke et al. [ 233 ], a sample size of at least 300 patients per condition is required to have sufficient power for applying multivariable prediction models. Nonetheless, they also noticed that a smaller sample size might be justified if studies are designed to develop prediction models that can be tested in future studies. Moreover, the results of this study can contribute to building a database including trials on BPD that can be analyzed with meta-analytic techniques.

Second, this study does not include a no treatment control group, which might affect internal validity. When improvements are found in both treatments, but no significant differences between the treatments, the absence of a control group implies that it cannot be ruled out that non-specific factors such as attention or time (maturation) caused the improvements. However, including a control group receiving no treatment would clearly be unethical (e.g., patients are at risk of suicide). For similar reasons, it is not possible to standardize medication use and crisis management sessions. Any additional treatment or medication use will be monitored and included in the analyses.

Third, one of the treatment elements of DBT is out of office hours between-session (telephone) consultation by the individual therapist. The targets of telephone consultation include, among others, reducing self-harm and suicidal behavior and teaching patients how to apply learned skills in everyday life in order to encourage skills generalization [ 19 ]. In the current study, some centers provide 24/7 access to telephone consultation by the patient’s individual therapist, while the other centers provide telephone consultation within the limitations of the individual therapists, or within working hours. In case of emergency, the standard emergency procedures of each center will be followed. Although outside of office hours availability is considered to be an essential element of DBT by some authors [ 113 , 234 ], the link between telephone consultation and outcome in DBT has not been evaluated [ 95 , 235 ]. There is some preliminary support for the importance of telephone consultation [ 236 ]. However, studies into the effectiveness of DBT that did not apply 24-h telephone consultation by the individual therapist have found positive outcomes (e.g., [ 235 , 237 ]). Van den Bosch and Sinnaeve [ 238 ] studied treatment programs of 25 DBT teams in the Netherlands. They found that only 36% of the DBT teams applied telephone consultation according to the guidelines of DBT. It can therefore be concluded that the current study is a good reflection of clinical practice, which enhances generalizability of our findings. Notwithstanding, we will monitor between-session (telephone) consultation within centers and examine potential effects.

Fourth, in this study, a component of treatment integrity (treatment adherence) will be assessed, which is, surprisingly, not standard procedure in trials investigating BPD treatments [ 25 ]. However, treatment integrity also constitutes of treatment differentiation and therapist competence [ 110 ]. Treatment adherence and treatment differentiation are closely related, in contrast to treatment adherence and therapist competence [ 239 ]. Treatment adherence represents a quantitative aspect of treatment integrity (i.e., how frequently a therapist utilizes prescribed techniques and procedures and avoids proscribed techniques and procedures), while competence represents a qualitative aspect (i.e., how well prescribed techniques and procedures are implemented) [ 109 ]. Adherence does not necessary presuppose competence; even with adequate adherence, therapists may deliver the treatment in an incompetent manner. The absence of competence ratings may threaten the validity of our results [ 109 ]. Moreover, treatment adherence will be assessed by trained master psychology students, whereas for DBT, adherence ratings by reliably trained therapists are considered the gold standard [ 240 , 241 ]. However, students will receive a training from experienced therapists.

Fifth, it is a subject of some debate whether the EQ-5D is a valid instrument to measure quality of life in BPD patients, which can affect the economic evaluation [ 81 ]. According to Brazier [ 242 ], the EQ-5D might not measure what matters to patients with psychiatric disorders. In addition, in a cost-effectiveness study among BPD patients, van Asselt et al. [ 79 ] found contradictory results on the incremental risk ratios when recovery was based on the EQ-5D compared to the BPDSI-IV. In contrast, adequate responsiveness of the EQ-5D has been found in a BPD sample [ 243 ]. In addition, Soeteman et al. [ 244 ] concluded that the EQ-5D is sensitive to changes in the health status of patients with cluster B personality disorders. In addition to the EQ-5D, quality of life will be assessed by a recently developed instrument specially developed for patients with mental health problems (MHQoL-7D; [ 197 ]). The validation of this instrument is currently in progress, but preliminary results are promising [ 197 ]. Another point for consideration is that conclusions with regard to the most cost-effective treatment choice can be affected by the amount the society is willing to pay for an additional unit of effectiveness (i.e., willingness-to-pay threshold). Soeteman et al. [ 244 ] concluded that outpatient psychotherapy for cluster B personality disorder patients is the optimal treatment choice in case society is not willing to pay more than €12.274; otherwise, day hospital psychotherapy was the optimal treatment choice. To date, there is no consensus about reasonable willingness-to-pay thresholds, although guidelines have been proposed by the Dutch healthcare authority [ 245 ]. We will therefore calculate the probability of each treatment being cost-effective for different willingness-to-pay values. As a result, the optimal treatment choice can be different for different willingness-to-pay values.

Finally, this study is conducted during the COVID-19 pandemic. The COVID-19 pandemic has significant disrupted effects on society and is related to increased burden of mental health among individuals with mental disorders [ 246 , 247 ]. Moreover, some authors suggest that patients with severe psychopathology, including BPD, may be especially at risk for symptom deterioration [ 247 , 248 ]. In addition, some patients will temporarily receive treatment via videoconferencing in case face-to-face treatment is restricted in mental healthcare centers. Research on the effectiveness of online individual psychotherapy has found positive effects for several mental health disorders, including PTSD [ 249 ], anxiety disorders [ 250 ], and depression [ 251 ]. However, research on the effectiveness of online group psychotherapy is scarce [ 95 , 252 ]. Consequently, we will control for a potential effect of the COVID-19 pandemic in the analyses.

Specialized evidence-based treatments have been developed and evaluated for BPD, including DBT and ST. However, BPD patients vary widely in their response to treatment, and poor response to one treatment does not imply poor response to another treatment. The selection of the optimal treatment for a particular patient is a daily task of the clinician, but very scant evidence is available to guide these decisions. This study will extend our knowledge on one of the main issues in psychotherapy research; understanding for whom a treatment works and how. As such, this study helps pave the way for an evidence-based personalized medicine for patients with BPD.

Trial status

Recruitment has started in January 2019 and is still ongoing. The estimated completion date of the recruitment is September 2021. Protocol version 07 is currently active.

Availability of data and materials

Not applicable.

Abbreviations

Autism Spectrum Quotient-10 items

Brief Experiential Avoidance Questionnaire

Borderline Personality Disorder

Borderline Personality Severity Index, fifth edition

Brief Symptom Inventory

Computerized Adaptive Test of Personality Disorder-Static Form

Cost-effectiveness analysis

Cost-effectiveness acceptability curves

Cost-utility analysis

Dutch Adult Reading Test

Dialectical Behavior Therapy

Dialectical Behavior Therapy-Ways of Coping Checklist

Difficulties in Emotion Regulation Scale 18

Difficulties in Emotion Regulation Scale Short Form

Diagnostic and Statistical Manual of Mental Disorders

Experience in Close Relationships-Revised

Experiences in Close Relationships-Relationship Structures questionnaire

5-level EuroQol 5D version

Frost Multidimensional Perfectionism Scale-Brief

General Psychiatric Management

Improving Access to Psychological Therapies

Locus of Control scale

Insomnia Severity Index

Intention-to-treat

Level of Personality Functioning Scale-Brief Form 2.0

Medical Ethics Committee of the Academic Medical Center

Mental Health Quality of Life seven-dimensional Questionnaire

Minnesota Multiphasic Personality Inventory-2 Restructured Form

Multidimensional Scale of Perceived Social Support

Nightmare Frequency Questionnaire

Outcome Rating Scale

Positive Mental Health scale

Posttraumatic Stress Disorder

Quality Adjusted Life Years

Randomized Clinical Trial

8-item Reflective Functioning Questionnaire

Structured Clinical Interview for DSM-5

Structured Clinical Interview for DSM-5 Disorders Clinician Version

Structural Clinical Interview for DSM-5 Personality Disorders

Structural Clinical Interview for DSM-5 Syndrome Disorders

Severity Indices of Personality Problems

Structured Clinical Interview for DSM-5 Screening Personality Questionnaire

Structured Clinical Interview for DSM-5 Syndroomstoornissen Vragenlijst

Schema Mode Inventory

Standard Protocol Items: Recommendations for Interventional Trials

Self-Reflection and Insight Scale

Schema Therapy

Traumatic Experience Checklist

Transference Focused Psychotherapy

Ten-Item Personality Inventory

Treatment Motivation Scales for Forensic Outpatient Treatment

Gordon Test of Visual Imagery Control

University of Rhode Island Change Assessment

Visual Analogue Scale

Working Alliance Inventory-Short

World Health Organization Disability Assessment Schedule 2.0

American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5®). 5th ed. Arlington: American Psychiatric Publishing; 2013.

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We would like to thank all patients, therapists, supervisors, research assistants, and students for their involvement in the study. We also thank our advisory board for sharing their knowledge and support, and their critical review of the study design. Finally, we are thankful to Herman Vinckers and Lindy Boyette who helped with the translation of the questionnaires.

This study received funding from Stichting Achmea Gezondheidszorg, CZ Fonds, and Stichting Volksbond Rotterdam. The funding bodies had no role in the design of the study and will not be involved in the collection, analysis, and interpretation of the data, nor in writing the manuscripts. The grant was subjected to a peer review process.

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CJMW: wrote the manuscript; involved in the implementation and coordination of the data collection; involved in the design of the study. AA: principal investigator; initial conception and design of the study. JHK: principal investigator; initial conception and design of the study. RPPPG: statistical counseling. RS: involved in the design of the study. MB, OMCB, ECPD, SGA, CJ, AMK, LK, MP, AS, FIS: responsible for the recruitment of participants and data collection in their mental healthcare center. All authors read, contributed and approved the final manuscript.

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Additional file 1..

SPIRIT 2013 checklist.

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Informed consent form (Appendix A) and additional informed consent form videoconferencing (Appendix B).

Additional file 3.

Overview of syndrome disorders assessed with the SCID-5-S.

Additional file 4.

Candidate predictors based on clinicians’ appraisals (Table 1) and candidate predictors based on the literature and suggestions of a patient representative of the Borderline Foundation of the Netherlands (Table 2).

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Wibbelink, C.J.M., Arntz, A., Grasman, R.P.P.P. et al. Towards optimal treatment selection for borderline personality disorder patients (BOOTS): a study protocol for a multicenter randomized clinical trial comparing schema therapy and dialectical behavior therapy. BMC Psychiatry 22 , 89 (2022). https://doi.org/10.1186/s12888-021-03670-9

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Published on 8.4.2024 in Vol 8 (2024)

Development and Implementation of an eHealth Oncohematonootric Program: Descriptive, Observational, Prospective Cohort Pilot Study

Authors of this article:

Original Paper

• Beatriz Sánchez-Quiñones 1, 2 * , MD   ; 
• Cristina Antón-Maldonado 1, 2 * , MD   ; 
• Nataly Ibarra Vega 1, 2 * , MD   ; 
• Isabel Martorell Mariné 3 * , PhD   ; 
• Amparo Santamaria 1, 2 * , MD, PhD  

1 Hybrid Hematology Department, University Hospital Vinalopó, Alicante, Elche, Spain

2 Hematoinnova Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana, Valencia, Spain

3 Nutrition Department, Nootric Inc, Barcelona, Spain

*all authors contributed equally

Corresponding Author:

Amparo Santamaria, MD, PhD

Hybrid Hematology Department

University Hospital Vinalopó

Calle Tonico Sansano Mora, 14

Alicante, Elche, 03293

Phone: 34 658981769

Fax:34 965781564

Email: [email protected]

Background: In oncohematology, both the development of the disease and the side effects of antineoplastic treatment often take a toll on patients’ physical and nutritional well-being. In this era of digital transformation, we launched a pioneering project for oncohematologic patients to promote adherence to a healthy lifestyle and improve their physical and nutritional well-being. We aim to achieve this goal by involving doctors and nutritionists through the Nootric app.

Objective: This study aims to assess the impact of the use of eHealth tools to facilitate nutrition and well-being in oncohematologic patients. We also aim to determine the usefulness of physical-nutritional management in improving tolerance to chemotherapy treatments within routine clinical practice.

Methods: We designed a descriptive, observational, longitudinal, prospective cohort pilot study that included a total of 22 patients from March to May 2022 in the Vinalopó University Hospital. The inclusion criteria were adults over 18 years of age diagnosed with oncohematological pathology in active chemotherapy treatment. An action plan was created to generate alerts between the doctor and the nutritionist. In the beginning, the patients were trained to use the app and received education highlighting the importance of nutrition and physical exercise. Sociodemographic, clinical-biological-analytical (eg, malnutrition index), health care impact, usability, and patient adherence data were collected. Tolerance to chemotherapy treatment and its health care impact were evaluated.

Results: We included 22 patients, 11 (50%) female and 11 (50%) male, ranging between 42 and 84 years of age. Among them, 13 (59%) were adherents to the program. The most frequent diseases were lymphoproliferative syndromes (13/22, 59%) and multiple myeloma (4/22, 18%). Moreover, 15 (68%) out of 22 patients received immunochemotherapy, while 7 (32%) out of 22 patients received biological treatment. No worsening of clinical-biological parameters was observed. Excluding dropouts and abandonments (n=9/22, 41%), the adherence rate was 81%, established by calculating the arithmetic mean of the adherence rates of 13 patients. No admission was observed due to gastrointestinal toxicity or discontinuation of treatment related to alterations in physical and nutritional well-being. In addition, only 5.5% of unscheduled consultations were increased due to incidents in well-being, mostly telematic (n=6/103 consultation are unscheduled). Additionally, 92% of patients reported an improvement in their nutritional habits (n=12/13), and up to 45% required adjustment of medical supportive treatment (n=5/11). There were no cases of grade 3 or greater gastrointestinal toxicity. All of this reflects improved tolerance to treatments. Patients reported a satisfaction score of 4.3 out of 5, while professionals rated their satisfaction at 4.8 out of 5.

Conclusions: We demonstrated the usefulness of integrating new technologies through a multidisciplinary approach. The Nootric app facilitated collaboration among the medical team, nutritionists, and patients. It enabled us to detect health issues related to physical-nutritional well-being, anticipate major complications, and mitigate potentially avoidable risks. Consequently, there was a decrease in unscheduled visits and admissions related to this condition.

Introduction

Hematological malignancies encompass a heterogeneous group of diseases that have different behaviors, evolution, treatments, and prognoses. However, all of them similarly compromise the patient’s nutritional and physical status. This is because both the development of the disease and antineoplastic treatment can lead to caloric-protein malnutrition, leading to a high prevalence of adverse effects in daily clinical practice [ 1 ]. New treatments and conventional chemotherapy lead to toxicity in the gastrointestinal tract, which has a direct impact on the patient's well-being and survival [ 2 - 9 ]. Medical management is often insufficient to carry out a comprehensive assessment of the patient’s physical and nutritional well-being. Therefore, professional support in this aspect through the application of information and communication technologies (ICTs) in patients’ everyday environment outside the hospital is a useful tool to improve well-being and reduce health care costs [ 6 , 10 - 12 ]. There is increasing evidence showing that lifestyle interventions can improve symptoms, quality of life, and even overall survival rates for patients with cancer. Digital interventions can help implement physical-nutritional behavior modifications and empower patients through healthy lifestyle education and support [ 13 ].

An effective system for patient physical-nutritional monitoring and treatment after nutritional risk assessment appears to be lacking. We identified the need for a standardized system to prevent and treat malnutrition related to these diseases. Currently, there are studies involving mobile apps for nutritional control and support to monitor dietary intake among patients who are hospitalized and face nutritional risks. These apps have demonstrated good acceptance among patients and have the potential to be useful dietary evaluation tools for use in clinical practice. These results suggest that such tools could be extrapolated to the field of oncohematology consultations [ 14 ].

The studies available so far confirm that the application of mobile apps, among other appropriately designed digital interventions, can be effective tools in nutritional interventions [ 2 , 3 , 15 ]. It is estimated that 59% or more of the currently available apps are health-related [ 2 ]. Some studies show that mobile app interventions can improve the quality of life of patients with malignant hemopathies by reducing symptoms [ 16 ].

However, many of these apps are not developed by nutrition experts, validated by official agencies, or part of routine use in the hospital setting. The use of mobile apps for nutritional interventions to improve dietary patterns, avoid or reduce side effects, and improve patient physical and nutritional well-being is a new challenge currently facing health care.

Therefore, we have launched a pioneering project with the aim of improving and mitigating malnutrition and side effects through proper nutritional and physical well-being monitoring. We aim to deliver this digital nutrition service via the Nootric app, thereby promoting patients’ adherence to a healthy lifestyle.

In this study, we included under the term “oncohematological patient” those who met the inclusion criteria: adults over 18 years of age with a diagnosis of oncohematologic pathology undergoing active treatment. The hematologic malignancies included were mostly lymphoproliferative syndromes and multiple myeloma. We analyzed only nutritional and physical parameters within this group.

We evaluated an intervention designed to support oncohematological patients in active treatment. The primary goal was to assess how eHealth tools in nutrition and well-being management impact patients in oncohematology. Additionally, we aimed to determine the usefulness of physical-nutritional management in improving tolerance to chemotherapy treatments within routine clinical practice.

As secondary objectives, on the one hand, we aimed to evaluate the usefulness of the application of a physical-nutritional intervention among oncohematological patients by observing serial cases. On the other hand, we wanted to evaluate the adequacy and acceptability of this app in this group of patients. We aimed to qualitatively evaluate how knowledge guides the reorientation of intervention strategies regarding physical-nutritional well-being in these patients. Finally, we aimed to understand the nutritional and physical requirements throughout each phase of these patients' treatment, considering the potential implications for their well-being. Measures of engagement with the intervention and semistructured interviews with intervention participants were used to evaluate the feasibility of the intervention.

Study Design

A descriptive, observational, prospective, longitudinal cohort pilot study was conducted among oncohematological patients in our hospital center ( Figure 1 ).

Recruitment took place between April and May 22. The exposure, follow-up, and data collection period lasted 3 months (from May 22 to August 22). The sample consisted of 22 patients and was not divided under any concept at the beginning of the study. During study development, patients who had good adherence were included in the exposed cohort. However, those who dropped out of the study and had a low adherence rate were included in the unexposed cohort. They were not taken into account in the analysis of the results, and no comparative study was performed. To ensure that older adults were not excluded due to the digital gap, we included patients aged above 80 years old, and during the first visit, we encouraged them to continue using the Nootric app.

Study Setting

This study was conducted in the province of Alicante, Spain, at Vialopó University Hospital, which tends to a culturally, linguistically, and socioeconomically diverse population. The participants were recruited from the hospital’s hematology department.

Participants

Patients were eligible to participate if they (1) were aged ≥18 years, (2) had a documented diagnosis of oncohematological pathology, and (3) were receiving medical treatment for cancer at the time of study initiation. Patients were excluded from the study if they (1) were children, adolescents, or pregnant women; (2) were due for surgery with hospital nutritional treatment; (3) were following nutritional care or hospital treatment; (4) had any acute or chronic condition that the practitioner believed limited their ability to participate in the study; (5) were unable to provide written consent; (6) were not literate; and (7) did not have a smartphone.

Intervention: OncohematoNootric Program

In recent years, there has been a growing use of eHealth tools, such as mobile apps, in nutritional interventions with good acceptance and results [ 2 , 3 ]. These technologies have been applied in different health care settings, such as mental health support and chronic disease management, to enable interaction with patients and promote engagement with health care interventions. Ultimately, they aim to increase the acceptability, use, and effectiveness of interventions [ 17 , 18 ]. However, to date, few studies have evaluated the effectiveness of these apps in routine clinical practice within the health care environment. There have been no studies in patients with hematological malignancies undergoing treatment [ 4 ].

The OncohematoNootric program involves a continuous approach and follow-up of patients by their physician and nutritionist through the Nootric app over 3 months via face-to-face/telematic consultations, voice calls, and direct chat through the app.

The intervention aims to provide nutritional-physical support tools to oncohematology patients receiving treatment who may develop adverse effects that put their physical and nutritional well-being at risk. The program provides training and information. It also facilitates risk assessment and clinical support, as needed, with the help of a physician-nutritionist alarm system.

Education Website

Nootric is a digital nutrition service that creates personalized nutrition plans tailored to the oncohematological patient, featuring recipes compatible with the potential side effects of treatment. It augments cognitive-behavioral therapy and provides guides and challenges that address aspects related to nutrition and its application in daily life. Physicians can monitor patients through the app using a dynamic panel that displays real-time actions. It also includes a chat feature to communicate with a dietitian-nutritionist.

In this study, all patients received dietary and exercise recommendations from professionals. The Nootric app aimed to help patients improve their health and well-being by facilitating behavioral changes.

Intervention Development and Patient Involvement

The intervention was designed in conjunction with patients, medical and nutritional health professionals, and professionals with expertise in eHealth and wellness management programs and technologists. No generative artificial intelligence (AI) was used in this study.

For program implementation, a training session on the use of the Nootric app was held with different medical teams. When the candidate patient was selected by the center, the team gave them a patient information sheet, an informed consent form, and an information leaflet. Once the patient agreed to participate in the pilot, they handed over the signed informed consent form and began to participate. The center registered the patient on the Nootric website by entering a code assigned to the patient. Once this registration was completed, the patient downloaded the app and logged in. Next, the patient completed a series of forms that served as a basis for the dietitian-nutritionist to establish their personalized plan. In addition, a clinical-biological test was performed via a blood test requested by the medical team and carried out at the hospital, after which the results were recorded, and the nutritional counseling intervention was initiated. At the beginning of the intervention, the health care professionals oriented the patient on the use of the Nootric application and emphasized the importance of good nutrition and physical exercise. Each patient received a weekly menu and shopping list, was able to upload photos of their meals during follow-up, and had direct access to an app-based chat with a nutritionist. During the study, the patient was able to contact their dietitian-nutritionist through the app’s chat function to solve nutritional doubts and receive motivational support to increase physical activities and food recording.

During the project, improvements were made to the app to provide better patient care, including adapting 70 menu prescriptions to be compatible with the potential side effects of the treatment, configuring menu items to ensure suitability for the most common side effects, and preparing and adapting informative guides and challenges. Other improvements included sending activity and hydration reminders, optimizing the internal messaging system for medical professionals to exchange information with nutritionists, and making functional changes to facilitate uploading files for medical professionals.

An action plan was created to generate alerts between the physician and nutritionist with all the possible adverse events that patients could present (eg, hyporexia, weight loss, skin and nail changes, diarrhea, dyspepsia, pain according to a visual analog scale, edema, fatigue, constipation, dysphagia, odynophagia, mucositis, canker sores, nausea, vomiting, diarrhea, insomnia, urinary and bladder problems, anuria, bleeding, flu-like symptoms, fever, xerostomia, rash, and pruritus), along with their severity criteria and the action plan to be followed by the doctor and nutritionist.

When any of these issues were detected, the nutritionist informed the doctor, who carried out an unscheduled telematic/presential consultation with the patient to resolve the issue with the nutritionist’s support. On the other hand, if the issue was detected by the doctor, the latter informed the nutritionist so that the patient could receive support from both. In this way, both professionals were always kept up to date on incidents and procedures. The communication channel between professionals was the Nootric web platform.

For patients who were observed to have low adherence to the program during the pilot, the professionals studied the potential causes and intensified their actions to avoid dropout.

During the follow-up period, a weekly evaluation of the variables under study was carried out by the professionals. Biweekly follow-up meetings were held with the team to track the program and make possible improvements. Patients completed weekly program evaluation forms. After the follow-up study, a satisfaction survey was conducted to qualitatively evaluate patient satisfaction and program usefulness.

A new clinical-biological test was performed to comparatively analyze the results obtained before and after the intervention ( Figure 2 ).

Study Outcomes

The primary outcome of the study was the health impact of the use of an eHealth tool related to nutrition and physical well-being on the oncohematological patient.This was measured by determining the following variables: nº alerts resolved, nº emergency visits, nº unscheduled consultations, nº treatments suspended, nº hospital admissions and improvement in nutritional habits according to the patient's perception, nº patients referred to the hospital’s Nutrition Unit, nº patients requiring adjustment of support treatment, and nº patients with gastrointestinal toxicity (which determines the impact on improving tolerance to treatments). The secondary outcomes included assessing the perceived improvement in the patients’ physical and nutritional well-being, determined through satisfaction and usefulness questionnaires at the end of the intervention. We also sought to assess the feasibility of the intervention, focusing on usability, acceptability, and adherence regarding different intervention components.

Data Collection and Study Procedures

The variables were collected on a form based on Microsoft Office Excel 2021 (Microsoft Corp), with each coded and subsequently exported to the SPSS statistical software (version 28.0; IBM Corp). To describe continuous variables with normal distribution, measures of central tendency were used, such as arithmetic mean. The qualitative variables were presented as frequency and proportion.

The variables collected at the beginning of the pilot study, during follow-up, and at the end were: (1) sociodemographic, including sex, age, level of education, main disease, comorbidities, and medication; (2) clinical-biological-analytical, with the following parameters included in the blood analysis to assess nutritional status and treatment toxicity and direct the professionals’ action plan: hemoglobin, creatinine clearance, calcium, total protein, albumin, vitamin B12, folic acid, ferritin, malnutrition index, total cholesterol, liver enzymes aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase, cancer medical treatment scheme, food consumption patterns measured through the form provided by Nootric through the app, and BMI; (3) health care impact; (4) usability; and (5) adherence.

To weight the usability of the application, the following user interaction variables were considered: viewing, rating, comments on recipes, uploaded photos, access to the chat, review of a guide or completion of a challenge (framed in cognitive-behavioral training), points achieved (result of the gamification provided by Nootric), and exercises displayed. Adherence was determined by analyzing each patient’s use of the Nootric app during the program application period. For adherence, the percentage of access to the Nootric application was calculated, considering the 120-day access as 100% adherence.

The evaluations performed can be viewed in more detail in Tables 1 and 2 and Figures 3 - 5 . The data extracted from the patients' medical records included results of the blood analysis, main disease, comorbidities and their medication, cancer medical treatment scheme, and health care impact variables.

a Patients received medical treatment, physical-nutritional recommendations, and close monitoring by their multidisciplinary assistance program. Most of the study population consisted of patients without severe comorbidities (18/22, 80%).

b These include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, (R-CHOP); adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD); rituximab, bortezomib, cyclophosphamide, adriamycin, and prednisone (VR-CAP); and methotrexate, regimens with melphalan, and 5-azacitidine.

c Therapeutic regimens included daratumumab, bortezomib, venetoclax, obinutuzumab, ibrutinib, imatinib, and nilotinib.

d These included 3 women and 3 men. Dropouts were considered as users with adherence rates below 7%, and they were not accounted for in the analytical results, body variables, and interactions with the app.

Ethical Considerations

This study was approved by the Ethics Committee of Vinalopó University Hospital on March 30, 2022. All research activities involving human patients in this study have been treated in accordance with the ethical guidelines established by The Organic Law on Data Protection. All necessary approvals were obtained, including for the analysis of the research data.

This study complies with the ethical provisions outlined in the informed consent, and any additional analysis has been conducted in accordance with the existing ethical approvals. Informed consent was obtained from all patients for the conduct of this study and publication of this article, and no compensation was provided. Patients were informed that the doctor would receive information about their progress.

To protect the privacy and confidentiality of the participants, all data collected in this study were anonymized before the analysis. Measures were taken to ensure that the participants’ identifiable details were not disclosed. We used an anonymous identification system that consisted of assigning an alphanumeric code to each patient registered on the Nootric web platform and in the Nootric app. No one else, apart from Ribera's medical team and Nootric's team of nutritionists, had access to the data in the Nootric app and website, which are confidential and encrypted.

The original informed consent allows for secondary analysis without additional consent; this includes data collected from the participants’ medical history.

Sociodemographic Variables

Of the 22 included patients, 11 (50%) were female and 11 (50%) were male, with an average age of 70 (range 42-84) years. Among them, 13 (60%) patients were under 65 years and 9 (40%) were over 65 years. The variables regarding sociodemographic characteristics, treatment received during the study, and program adherence are described in Table 1 .

Clinical-Biological-Analytical Variables

A clinical-biological test was conducted for all patients at the beginning of the study, but only 13 (59%) out of 22 patients completed it. On this population, we performed the analysis of the results. Table 2 presents all the analyzed laboratory parameters and the results at the beginning and end of the

intervention. Some of the relevant data are shown in Figure 3 . Some patients received corticosteroid therapy, which increases the risk of developing steroidal hyperglycemia. These patients benefited from an adapted physical-nutritional plan. There were no patients in the study who presented with alterations in blood glucose levels. Of the 2 (15%) patients who had dyslipidemia at baseline, 1 (8%) patient did not maintain dyslipidemia at the end of the study. Furthermore, 1 (8%) patient presented with iron overload secondary to a high transfusion requirement. Iron chelation therapy was initiated, which triggered a grade 3 hepatotoxicity. After discontinuing it, it improved clinically and analytically to grade 1. Of 6 (46%) patients with malnutrition at baseline, only 1 (8%) patient still had malnutrition at the end of the study. Of the 4 (30%) patients who presented with hypoproteinemia at baseline, 1 (23%) did not have it at the end. Moreover, 1 patient (8%) presented with a folic deficit at baseline and maintained it at baseline despite having received supportive treatment and dietary recommendations.

The clinical interview confirmed that treatment compliance was inadequate. Among 13 patients who had anemia at the beginning of the study, 3 (23%) did not maintain it at the end of the study. Conversely, 3 (23%) of the 13 patients who had anemia at the end of the study did not have it at baseline. None of the causes were caused by vitamin B12, folic acid, or iron deficiency but by myelotoxicity due to targeted cancer therapy.

Program Adherence and Usability

A total of 6 (27%) out of 22 patients abandoned the study due to a lack of adherence to the program, attributed to advanced age, insufficient socioeconomic level to ensure proper use of the app, lack of family support for improving adherence, and lack of initiative to establish a change in the physical-nutritional routine. They were not taken into account in the analysis of the results. In addition, users with less than 7% adherence were considered dropouts (3/22, 14%), and they were not taken into account in the analysis of the results. None of these patients were older adults or dropped out due to the digital gap.

Excluding dropouts and abandonments (n=9, 30%), the adherence rate was 81%, established by calculating the arithmetic mean of the adherence rates of 13 patients, much higher than the average rate in well-being. Of the 22 patients, between 7 and 11 (30%-50%) perceived an improvement in well-being, determined by the satisfaction survey conducted at the end of the study. To determine the adherence rate of each patient, the use of the app by the patients was evaluated and the parameters were nº interactions with the app, use of the chat with the nutritionist, nº interactions with the recipes, nº photos of recipes uploaded by the patients, and gamification points earned ( Figure 4 ). Regarding the impact of usability, we obtained an average of 655 impacts per app user ( Figure 4 ).

Impact on Health Care

Regarding the impact on health care quality, Table 2 and Figure 5 show data that demonstrates highly satisfactory results. None of the total emergency visits were related to physical and nutritional well-being.

No hospitalizations occurred during the study for any cause, including those related to physical and nutritional well-being. No patient had to be referred to the hospital’s Nutrition Unit. Of the total number of medical consultations carried out, only 5.5% (6/103) were unscheduled and none of them were carried out for physical or nutritional issues. A total of 7 patients presented toxicity, among which 5 (71%) were cases of digestive toxicity. Of the 11 patients who required adjustment of supportive or symptomatic treatment due to toxicity, 5 (45%) had digestive toxicity. No treatment was suspended due to physical or nutritional conditions.

The patients showed an improvement in tolerance to chemotherapy treatments since there were no cases of grade 3 or higher gastrointestinal toxicity, defined as complications requiring intravenous support treatment. There were also no hospitalizations, emergency visits, or chemotherapy treatment discontinuations for this reason. A high percentage of patients (12/13, 92%) perceived an improvement in their nutritional habits.

Impact on Patients’ Perceived Improvements in Physical and Nutritional Well-Being

At the end of the study, the Nootric team disseminated an anonymous survey to measure satisfaction and usefulness for the patients and medical professionals involved. This enabled us to evaluate the impact on the perceived improvement in the patients’ physical and nutritional well-being. We observed that the users who adhered adequately to the program showed an improvement in this aspect. A total of 12 questionnaires were filled out by patients.

The average satisfaction rating among professionals was 4.8 out of 5, while patients rated their satisfaction at 4.3 out of 5. Table 3 highlights these results.

Our study is based on a multidisciplinary nutritional and exercise support program for oncohematological patients undergoing active treatment using new technologies. This study provides initial data on the effectiveness of a novel physical and nutritional support program aimed at patients with malignant hemopathies (largely represented in our study as lymphoproliferative syndromes and multiple myeloma) receiving targeted cancer treatment. It also provides a detailed evaluation of the implementation, adoption, and overall acceptability of this digital care intervention through a mobile app. The evaluation design has been adapted to the study objectives to provide new data to enable a better estimation of such an intervention’s impact and inform further development of digital care interventions for malignant blood diseases under active treatment.

Principal Findings

We did not observe any hospital admissions or discontinuation of chemotherapy treatment related to the patients' physical-nutritional well-being, supporting the benefit of the program. Adequate nutritional support was provided to ensure patients' well-being and mitigate the need for referral to the hospital's Nutrition Unit. Regarding the impact on physical and nutritional well-being, we observed that users who adhered adequately to the program improved in this aspect.

We observed a reduction in the number of unplanned consultations related to physical and nutritional well-being. In terms of impact on health care quality, the results demonstrated highly satisfactory results. None of the total emergency visits were related to physical and nutritional well-being. Moreover, the intervention received a high satisfaction rating from both professionals and patients.

Regarding other works in the field, there is little information about the best nutritional support for patients with cancer [ 9 , 19 , 20 ]. Antineoplastic agents are known to be associated with gastrointestinal complications that lead to physical and nutritional repercussions, which can decrease well-being and result in death due to malnutrition [ 19 ]. Additionally, early nutritional intervention can improve prognosis and reduce the disease’s complication rate [ 12 , 19 ].

One study used a novel mobile app to assess and evaluate dietary behaviors in 39 oncologic patients. Although 5 patients dropped out prior to the study, the authors concluded that participants who tracked their daily dietary habits using a mobile phone app were more likely to reach their nutritional goals than the control patients. Other studies have used mobile apps to record nutritional status and activity levels in patients with breast cancer or other or other diseases, but none of them are similar to our study [ 20 ]. Our study was performed by a multidisciplinary team using both the app and the internet to maintain contact with the patients. Furthermore, the multidisciplinary team tailored each patient's diet to suit their individual needs throughout their cancer treatment journey, particularly addressing gastrointestinal toxicities associated with active chemotherapy. This underscores the effectiveness of such technologies for integration into clinical practice without compromising the human touch in health care delivery.

Limitations and Strengths

This study highlights the importance of eHealth programs in addressing nutrition and

well-being among oncohematology patients, offering significant value in multidisciplinary care management. The use of the Nootric app allowed for improved health care indicators and physical-nutritional well-being, promoting better patient outcomes.

Another notable strength of this study is the finding that over 50% (n=11) of the patients improved their physical-nutritional habits, leading to a considerable enhancement in their perception of well-being.

In terms of limitations, we must point out that this study has a small sample size of 22 patients, which may limit the generalizability of the results. Moreover, we experienced a 27% (6/22) dropout rate due to a lack of adherence to the program, which could have affected the overall results. In addition, not all of those who completed the study completed the clinical-biological tests. Finally, we acknowledge that the 12-week follow-up period might not adequately capture the program’s clinical impact on adherence to healthy habits and improved physical and nutritional well-being.

In conclusion, using targeted eHealth programs for nutrition and well-being among oncohematological patients undergoing active treatment offers significant value in multidisciplinary care management. This is achieved through enhanced interaction between physicians, dietitian-nutritionists, and patients via a digital nutrition service, such as the Nootric app. Supporting patients throughout their cancer journey, these technologies serve as valuable tools for integration into clinical practice without detracting from the human aspect of health care. Therefore, implementing projects that leverage new technologies in routine holistic clinical practice for oncohematological patients could prove cost-effective in both the short and long term. By facilitating the early detection of health issues related to physical-nutritional well-being and anticipating potential complications, these initiatives may help reduce unscheduled visits and admissions related to this condition.

Acknowledgments

We extend our gratitude to all the patients and families involved in this study.

Data Availability

Our data adheres to open science availability guidelines for broader research accessibility.

Conflicts of Interest

None declared.

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Abbreviations

Edited by A Mavragani; submitted 03.06.23; peer-reviewed by C Herrero; comments to author 02.10.23; revised version received 13.10.23; accepted 14.02.24; published 08.04.24.

©Beatriz Sánchez-Quiñones, Cristina Antón-Maldonado, Nataly Ibarra Vega, Isabel Martorell Mariné, Amparo Santamaria. Originally published in JMIR Formative Research (https://formative.jmir.org), 08.04.2024.

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