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What Is Problem-Solving Therapy?

Arlin Cuncic, MA, is the author of "Therapy in Focus: What to Expect from CBT for Social Anxiety Disorder" and "7 Weeks to Reduce Anxiety." She has a Master's degree in psychology.

problem solving therapy protocol

Daniel B. Block, MD, is an award-winning, board-certified psychiatrist who operates a private practice in Pennsylvania.

problem solving therapy protocol

Verywell / Madelyn Goodnight


Things to consider, how to get started.

Problem-solving therapy is a form of therapy that provides patients with tools to identify and solve problems that arise from life stressors, both big and small. Its aim is to improve your overall quality of life and reduce the negative impact of psychological and physical illness.

Problem-solving therapy can be used to treat depression , among other conditions. It can be administered by a doctor or mental health professional and may be combined with other treatment approaches.

Problem-solving therapy is based on a model that takes into account the importance of real-life problem-solving. In other words, the key to managing the impact of stressful life events is to know how to address issues as they arise. Problem-solving therapy is very practical in its approach and is only concerned with the present, rather than delving into your past.

This form of therapy can take place one-on-one or in a group format and may be offered in person or online via telehealth . Sessions can be anywhere from 30 minutes to two hours long. 

There are two major components that make up the problem-solving therapy framework:

  • Applying a positive problem-solving orientation to your life
  • Using problem-solving skills

A positive problem-solving orientation means viewing things in an optimistic light, embracing self-efficacy , and accepting the idea that problems are a normal part of life. Problem-solving skills are behaviors that you can rely on to help you navigate conflict, even during times of stress. This includes skills like:

  • Knowing how to identify a problem
  • Defining the problem in a helpful way
  • Trying to understand the problem more deeply
  • Setting goals related to the problem
  • Generating alternative, creative solutions to the problem
  • Choosing the best course of action
  • Implementing the choice you have made
  • Evaluating the outcome to determine next steps

Problem-solving therapy is all about training you to become adaptive in your life so that you will start to see problems as challenges to be solved instead of insurmountable obstacles. It also means that you will recognize the action that is required to engage in effective problem-solving techniques.

One problem-solving technique, called planful problem-solving, involves following a series of steps to fix issues in a healthy, constructive way:

  • Problem definition and formulation : This step involves identifying the real-life problem that needs to be solved and formulating it in a way that allows you to generate potential solutions.
  • Generation of alternative solutions : This stage involves coming up with various potential solutions to the problem at hand. The goal in this step is to brainstorm options to creatively address the life stressor in ways that you may not have previously considered.
  • Decision-making strategies : This stage involves discussing different strategies for making decisions as well as identifying obstacles that may get in the way of solving the problem at hand.
  • Solution implementation and verification : This stage involves implementing a chosen solution and then verifying whether it was effective in addressing the problem.

Other techniques your therapist may go over include:

  • Problem-solving multitasking , which helps you learn to think clearly and solve problems effectively even during times of stress
  • Stop, slow down, think, and act (SSTA) , which is meant to encourage you to become more emotionally mindful when faced with conflict
  • Healthy thinking and imagery , which teaches you how to embrace more positive self-talk while problem-solving

What Problem-Solving Therapy Can Help With

Problem-solving therapy addresses issues related to life stress and is focused on helping you find solutions to concrete issues. This approach can be applied to problems associated with a variety of psychological and physiological symptoms.

Problem-solving therapy may help address mental health issues, like:

  • Chronic stress due to accumulating minor issues
  • Complications associated with traumatic brain injury (TBI)
  • Emotional distress
  • Post-traumatic stress disorder (PTSD)
  • Problems associated with a chronic disease like cancer, heart disease, or diabetes
  • Self-harm and feelings of hopelessness
  • Substance use
  • Suicidal ideation

This form of therapy is also helpful for dealing with specific life problems, such as:

  • Death of a loved one
  • Dissatisfaction at work
  • Everyday life stressors
  • Family problems
  • Financial difficulties
  • Relationship conflicts

Your doctor or mental healthcare professional will be able to advise whether problem-solving therapy could be helpful for your particular issue. In general, if you are struggling with specific, concrete problems that you are having trouble finding solutions for, problem-solving therapy could be helpful for you.

Benefits of Problem-Solving Therapy

The skills learned in problem-solving therapy can be helpful for managing all areas of your life. These can include:

  • Being able to identify which stressors trigger your negative emotions (e.g., sadness, anger)
  • Confidence that you can handle problems that you face
  • Having a systematic approach on how to deal with life's problems
  • Having a toolbox of strategies to solve the problems you face
  • Increased confidence to find creative solutions
  • Knowing how to identify which barriers will impede your progress
  • Knowing how to manage emotions when they arise
  • Reduced avoidance and increased action-taking
  • The ability to accept life problems that can't be solved
  • The ability to make effective decisions
  • The development of patience (realizing that not all problems have a "quick fix")

This form of therapy was initially developed to help people combat stress through effective problem-solving, and it was later adapted to specifically address clinical depression. Today, much of the research on problem-solving therapy deals with its effectiveness in treating depression.

Problem-solving therapy has been shown to help depression in: 

  • Older adults
  • People coping with serious illnesses like breast cancer

Problem-solving therapy also appears to be effective as a brief treatment for depression, offering benefits in as little as six to eight sessions with a therapist or another healthcare professional. This may make it a good option for someone who is unable to commit to a lengthier treatment for depression.

Problem-solving therapy is not a good fit for everyone. It may not be effective at addressing issues that don't have clear solutions, like seeking meaning or purpose in life. Problem-solving therapy is also intended to treat specific problems, not general habits or thought patterns .

In general, it's also important to remember that problem-solving therapy is not a primary treatment for mental disorders. If you are living with the symptoms of a serious mental illness such as bipolar disorder or schizophrenia , you may need additional treatment with evidence-based approaches for your particular concern.

Problem-solving therapy is best aimed at someone who has a mental or physical issue that is being treated separately, but who also has life issues that go along with that problem that has yet to be addressed.

For example, it could help if you can't clean your house or pay your bills because of your depression, or if a cancer diagnosis is interfering with your quality of life.

Your doctor may be able to recommend therapists in your area who utilize this approach, or they may offer it themselves as part of their practice. You can also search for a problem-solving therapist with help from the American Psychological Association’s (APA) Society of Clinical Psychology .

If receiving problem-solving therapy from a doctor or mental healthcare professional is not an option for you, you could also consider implementing it as a self-help strategy using a workbook designed to help you learn problem-solving skills on your own.

During your first session, your therapist may spend some time explaining their process and approach. They may ask you to identify the problem you’re currently facing, and they’ll likely discuss your goals for therapy.

Problem-solving therapy may be a short-term intervention that's focused on solving a specific issue in your life. If you need further help with something more pervasive, it can also become a longer-term treatment option.

Pierce D. Problem solving therapy - Use and effectiveness in general practice . Aust Fam Physician . 2012;41(9):676-679.

Cuijpers P, Wit L de, Kleiboer A, Karyotaki E, Ebert DD. Problem-solving therapy for adult depression: An updated meta-analysis . Eur Psychiatry . 2018;48(1):27-37. doi:10.1016/j.eurpsy.2017.11.006

Nezu AM, Nezu CM, D'Zurilla TJ. Problem-Solving Therapy: A Treatment Manual . New York; 2013. doi:10.1891/9780826109415.0001

Hatcher S, Sharon C, Parag V, Collins N. Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial . Br J Psychiatry . 2011;199(4):310-316. doi:10.1192/bjp.bp.110.090126

Sorsdahl K, Stein DJ, Corrigall J, et al. The efficacy of a blended motivational interviewing and problem solving therapy intervention to reduce substance use among patients presenting for emergency services in South Africa: A randomized controlled trial . Subst Abuse Treat Prev Policy . 2015;10(1):46. doi:doi.org/10.1186/s13011-015-0042-1

Kirkham JG, Choi N, Seitz DP. Meta-analysis of problem solving therapy for the treatment of major depressive disorder in older adults . Int J Geriatr Psychiatry . 2016;31(5):526-535. doi:10.1002/gps.4358

Garand L, Rinaldo DE, Alberth MM, et al. Effects of problem solving therapy on mental health outcomes in family caregivers of persons with a new diagnosis of mild cognitive impairment or early dementia: A randomized controlled trial . Am J Geriatr Psychiatry . 2014;22(8):771-781. doi:10.1016/j.jagp.2013.07.007

Hopko DR, Armento MEA, Robertson SMC, et al. Brief behavioral activation and problem-solving therapy for depressed breast cancer patients: Randomized trial . J Consult Clin Psychol . 2011;79(6):834-849. doi:10.1037/a0025450

Nieuwsma JA, Trivedi RB, McDuffie J, Kronish I, Benjamin D, Williams JW. Brief psychotherapy for depression: A systematic review and meta-analysis . Int J Psychiatry Med . 2012;43(2):129-151. doi:10.2190/PM.43.2.c

By Arlin Cuncic, MA Arlin Cuncic, MA, is the author of "Therapy in Focus: What to Expect from CBT for Social Anxiety Disorder" and "7 Weeks to Reduce Anxiety." She has a Master's degree in psychology.

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10 Best Problem-Solving Therapy Worksheets & Activities

Problem solving therapy

Cognitive science tells us that we regularly face not only well-defined problems but, importantly, many that are ill defined (Eysenck & Keane, 2015).

Sometimes, we find ourselves unable to overcome our daily problems or the inevitable (though hopefully infrequent) life traumas we face.

Problem-Solving Therapy aims to reduce the incidence and impact of mental health disorders and improve wellbeing by helping clients face life’s difficulties (Dobson, 2011).

This article introduces Problem-Solving Therapy and offers techniques, activities, and worksheets that mental health professionals can use with clients.

Before you continue, we thought you might like to download our three Positive Psychology Exercises for free . These science-based exercises explore fundamental aspects of positive psychology, including strengths, values, and self-compassion, and will give you the tools to enhance the wellbeing of your clients, students, or employees.

This Article Contains:

What is problem-solving therapy, 14 steps for problem-solving therapy, 3 best interventions and techniques, 7 activities and worksheets for your session, fascinating books on the topic, resources from positivepsychology.com, a take-home message.

Problem-Solving Therapy assumes that mental disorders arise in response to ineffective or maladaptive coping. By adopting a more realistic and optimistic view of coping, individuals can understand the role of emotions and develop actions to reduce distress and maintain mental wellbeing (Nezu & Nezu, 2009).

“Problem-solving therapy (PST) is a psychosocial intervention, generally considered to be under a cognitive-behavioral umbrella” (Nezu, Nezu, & D’Zurilla, 2013, p. ix). It aims to encourage the client to cope better with day-to-day problems and traumatic events and reduce their impact on mental and physical wellbeing.

Clinical research, counseling, and health psychology have shown PST to be highly effective in clients of all ages, ranging from children to the elderly, across multiple clinical settings, including schizophrenia, stress, and anxiety disorders (Dobson, 2011).

Can it help with depression?

PST appears particularly helpful in treating clients with depression. A recent analysis of 30 studies found that PST was an effective treatment with a similar degree of success as other successful therapies targeting depression (Cuijpers, Wit, Kleiboer, Karyotaki, & Ebert, 2020).

Other studies confirm the value of PST and its effectiveness at treating depression in multiple age groups and its capacity to combine with other therapies, including drug treatments (Dobson, 2011).

The major concepts

Effective coping varies depending on the situation, and treatment typically focuses on improving the environment and reducing emotional distress (Dobson, 2011).

PST is based on two overlapping models:

Social problem-solving model

This model focuses on solving the problem “as it occurs in the natural social environment,” combined with a general coping strategy and a method of self-control (Dobson, 2011, p. 198).

The model includes three central concepts:

  • Social problem-solving
  • The problem
  • The solution

The model is a “self-directed cognitive-behavioral process by which an individual, couple, or group attempts to identify or discover effective solutions for specific problems encountered in everyday living” (Dobson, 2011, p. 199).

Relational problem-solving model

The theory of PST is underpinned by a relational problem-solving model, whereby stress is viewed in terms of the relationships between three factors:

  • Stressful life events
  • Emotional distress and wellbeing
  • Problem-solving coping

Therefore, when a significant adverse life event occurs, it may require “sweeping readjustments in a person’s life” (Dobson, 2011, p. 202).

problem solving therapy protocol

  • Enhance positive problem orientation
  • Decrease negative orientation
  • Foster ability to apply rational problem-solving skills
  • Reduce the tendency to avoid problem-solving
  • Minimize the tendency to be careless and impulsive

D’Zurilla’s and Nezu’s model includes (modified from Dobson, 2011):

  • Initial structuring Establish a positive therapeutic relationship that encourages optimism and explains the PST approach.
  • Assessment Formally and informally assess areas of stress in the client’s life and their problem-solving strengths and weaknesses.
  • Obstacles to effective problem-solving Explore typically human challenges to problem-solving, such as multitasking and the negative impact of stress. Introduce tools that can help, such as making lists, visualization, and breaking complex problems down.
  • Problem orientation – fostering self-efficacy Introduce the importance of a positive problem orientation, adopting tools, such as visualization, to promote self-efficacy.
  • Problem orientation – recognizing problems Help clients recognize issues as they occur and use problem checklists to ‘normalize’ the experience.
  • Problem orientation – seeing problems as challenges Encourage clients to break free of harmful and restricted ways of thinking while learning how to argue from another point of view.
  • Problem orientation – use and control emotions Help clients understand the role of emotions in problem-solving, including using feelings to inform the process and managing disruptive emotions (such as cognitive reframing and relaxation exercises).
  • Problem orientation – stop and think Teach clients how to reduce impulsive and avoidance tendencies (visualizing a stop sign or traffic light).
  • Problem definition and formulation Encourage an understanding of the nature of problems and set realistic goals and objectives.
  • Generation of alternatives Work with clients to help them recognize the wide range of potential solutions to each problem (for example, brainstorming).
  • Decision-making Encourage better decision-making through an improved understanding of the consequences of decisions and the value and likelihood of different outcomes.
  • Solution implementation and verification Foster the client’s ability to carry out a solution plan, monitor its outcome, evaluate its effectiveness, and use self-reinforcement to increase the chance of success.
  • Guided practice Encourage the application of problem-solving skills across multiple domains and future stressful problems.
  • Rapid problem-solving Teach clients how to apply problem-solving questions and guidelines quickly in any given situation.

Success in PST depends on the effectiveness of its implementation; using the right approach is crucial (Dobson, 2011).

Problem-solving therapy – Baycrest

The following interventions and techniques are helpful when implementing more effective problem-solving approaches in client’s lives.

First, it is essential to consider if PST is the best approach for the client, based on the problems they present.

Is PPT appropriate?

It is vital to consider whether PST is appropriate for the client’s situation. Therapists new to the approach may require additional guidance (Nezu et al., 2013).

Therapists should consider the following questions before beginning PST with a client (modified from Nezu et al., 2013):

  • Has PST proven effective in the past for the problem? For example, research has shown success with depression, generalized anxiety, back pain, Alzheimer’s disease, cancer, and supporting caregivers (Nezu et al., 2013).
  • Is PST acceptable to the client?
  • Is the individual experiencing a significant mental or physical health problem?

All affirmative answers suggest that PST would be a helpful technique to apply in this instance.

Five problem-solving steps

The following five steps are valuable when working with clients to help them cope with and manage their environment (modified from Dobson, 2011).

Ask the client to consider the following points (forming the acronym ADAPT) when confronted by a problem:

  • Attitude Aim to adopt a positive, optimistic attitude to the problem and problem-solving process.
  • Define Obtain all required facts and details of potential obstacles to define the problem.
  • Alternatives Identify various alternative solutions and actions to overcome the obstacle and achieve the problem-solving goal.
  • Predict Predict each alternative’s positive and negative outcomes and choose the one most likely to achieve the goal and maximize the benefits.
  • Try out Once selected, try out the solution and monitor its effectiveness while engaging in self-reinforcement.

If the client is not satisfied with their solution, they can return to step ‘A’ and find a more appropriate solution.

Positive self-statements

When dealing with clients facing negative self-beliefs, it can be helpful for them to use positive self-statements.

Use the following (or add new) self-statements to replace harmful, negative thinking (modified from Dobson, 2011):

  • I can solve this problem; I’ve tackled similar ones before.
  • I can cope with this.
  • I just need to take a breath and relax.
  • Once I start, it will be easier.
  • It’s okay to look out for myself.
  • I can get help if needed.
  • Other people feel the same way I do.
  • I’ll take one piece of the problem at a time.
  • I can keep my fears in check.
  • I don’t need to please everyone.

Worksheets for problem solving therapy

5 Worksheets and workbooks

Problem-solving self-monitoring form.

Answering the questions in the Problem-Solving Self-Monitoring Form provides the therapist with necessary information regarding the client’s overall and specific problem-solving approaches and reactions (Dobson, 2011).

Ask the client to complete the following:

  • Describe the problem you are facing.
  • What is your goal?
  • What have you tried so far to solve the problem?
  • What was the outcome?

Reactions to Stress

It can be helpful for the client to recognize their own experiences of stress. Do they react angrily, withdraw, or give up (Dobson, 2011)?

The Reactions to Stress worksheet can be given to the client as homework to capture stressful events and their reactions. By recording how they felt, behaved, and thought, they can recognize repeating patterns.

What Are Your Unique Triggers?

Helping clients capture triggers for their stressful reactions can encourage emotional regulation.

When clients can identify triggers that may lead to a negative response, they can stop the experience or slow down their emotional reaction (Dobson, 2011).

The What Are Your Unique Triggers ? worksheet helps the client identify their triggers (e.g., conflict, relationships, physical environment, etc.).

Problem-Solving worksheet

Imagining an existing or potential problem and working through how to resolve it can be a powerful exercise for the client.

Use the Problem-Solving worksheet to state a problem and goal and consider the obstacles in the way. Then explore options for achieving the goal, along with their pros and cons, to assess the best action plan.

Getting the Facts

Clients can become better equipped to tackle problems and choose the right course of action by recognizing facts versus assumptions and gathering all the necessary information (Dobson, 2011).

Use the Getting the Facts worksheet to answer the following questions clearly and unambiguously:

  • Who is involved?
  • What did or did not happen, and how did it bother you?
  • Where did it happen?
  • When did it happen?
  • Why did it happen?
  • How did you respond?

2 Helpful Group Activities

While therapists can use the worksheets above in group situations, the following two interventions work particularly well with more than one person.

Generating Alternative Solutions and Better Decision-Making

A group setting can provide an ideal opportunity to share a problem and identify potential solutions arising from multiple perspectives.

Use the Generating Alternative Solutions and Better Decision-Making worksheet and ask the client to explain the situation or problem to the group and the obstacles in the way.

Once the approaches are captured and reviewed, the individual can share their decision-making process with the group if they want further feedback.


Visualization can be performed with individuals or in a group setting to help clients solve problems in multiple ways, including (Dobson, 2011):

  • Clarifying the problem by looking at it from multiple perspectives
  • Rehearsing a solution in the mind to improve and get more practice
  • Visualizing a ‘safe place’ for relaxation, slowing down, and stress management

Guided imagery is particularly valuable for encouraging the group to take a ‘mental vacation’ and let go of stress.

Ask the group to begin with slow, deep breathing that fills the entire diaphragm. Then ask them to visualize a favorite scene (real or imagined) that makes them feel relaxed, perhaps beside a gently flowing river, a summer meadow, or at the beach.

The more the senses are engaged, the more real the experience. Ask the group to think about what they can hear, see, touch, smell, and even taste.

Encourage them to experience the situation as fully as possible, immersing themselves and enjoying their place of safety.

Such feelings of relaxation may be able to help clients fall asleep, relieve stress, and become more ready to solve problems.

We have included three of our favorite books on the subject of Problem-Solving Therapy below.

1. Problem-Solving Therapy: A Treatment Manual – Arthur Nezu, Christine Maguth Nezu, and Thomas D’Zurilla

Problem-Solving Therapy

This is an incredibly valuable book for anyone wishing to understand the principles and practice behind PST.

Written by the co-developers of PST, the manual provides powerful toolkits to overcome cognitive overload, emotional dysregulation, and the barriers to practical problem-solving.

Find the book on Amazon .

2. Emotion-Centered Problem-Solving Therapy: Treatment Guidelines – Arthur Nezu and Christine Maguth Nezu

Emotion-Centered Problem-Solving Therapy

Another, more recent, book from the creators of PST, this text includes important advances in neuroscience underpinning the role of emotion in behavioral treatment.

Along with clinical examples, the book also includes crucial toolkits that form part of a stepped model for the application of PST.

3. Handbook of Cognitive-Behavioral Therapies – Keith Dobson and David Dozois

Handbook of Cognitive-Behavioral Therapies

This is the fourth edition of a hugely popular guide to Cognitive-Behavioral Therapies and includes a valuable and insightful section on Problem-Solving Therapy.

This is an important book for students and more experienced therapists wishing to form a high-level and in-depth understanding of the tools and techniques available to Cognitive-Behavioral Therapists.

For even more tools to help strengthen your clients’ problem-solving skills, check out the following free worksheets from our blog.

  • Case Formulation Worksheet This worksheet presents a four-step framework to help therapists and their clients come to a shared understanding of the client’s presenting problem.
  • Understanding Your Default Problem-Solving Approach This worksheet poses a series of questions helping clients reflect on their typical cognitive, emotional, and behavioral responses to problems.
  • Social Problem Solving: Step by Step This worksheet presents a streamlined template to help clients define a problem, generate possible courses of action, and evaluate the effectiveness of an implemented solution.
  • 17 Positive Psychology Exercises If you’re looking for more science-based ways to help others enhance their wellbeing, check out this signature collection of 17 validated positive psychology tools for practitioners . Use them to help others flourish and thrive.

While we are born problem-solvers, facing an incredibly diverse set of challenges daily, we sometimes need support.

Problem-Solving Therapy aims to reduce stress and associated mental health disorders and improve wellbeing by improving our ability to cope. PST is valuable in diverse clinical settings, ranging from depression to schizophrenia, with research suggesting it as a highly effective treatment for teaching coping strategies and reducing emotional distress.

Many PST techniques are available to help improve clients’ positive outlook on obstacles while reducing avoidance of problem situations and the tendency to be careless and impulsive.

The PST model typically assesses the client’s strengths, weaknesses, and coping strategies when facing problems before encouraging a healthy experience of and relationship with problem-solving.

Why not use this article to explore the theory behind PST and try out some of our powerful tools and interventions with your clients to help them with their decision-making, coping, and problem-solving?

We hope you enjoyed reading this article. Don’t forget to download our three Positive Psychology Exercises for free .

  • Cuijpers, P., Wit, L., Kleiboer, A., Karyotaki, E., & Ebert, D. (2020). Problem-solving therapy for adult depression: An updated meta-analysis. European P sychiatry ,  48 (1), 27–37.
  • Dobson, K. S. (2011). Handbook of cognitive-behavioral therapies (3rd ed.). Guilford Press.
  • Dobson, K. S., & Dozois, D. J. A. (2021). Handbook of cognitive-behavioral therapies  (4th ed.). Guilford Press.
  • Eysenck, M. W., & Keane, M. T. (2015). Cognitive psychology: A student’s handbook . Psychology Press.
  • Nezu, A. M., & Nezu, C. M. (2009). Problem-solving therapy DVD . Retrieved September 13, 2021, from https://www.apa.org/pubs/videos/4310852
  • Nezu, A. M., & Nezu, C. M. (2018). Emotion-centered problem-solving therapy: Treatment guidelines. Springer.
  • Nezu, A. M., Nezu, C. M., & D’Zurilla, T. J. (2013). Problem-solving therapy: A treatment manual . Springer.

problem solving therapy protocol

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Evidence-Based Treatment and Practice with Older Adults: Theory, Practice, and Research

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5 Problem-Solving Therapy: Theory and Practice

  • Published: May 2017
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Problem-solving therapy (PST) is a psychosocial intervention that teaches clients to cope with the stress of “here-and-now” problems in order to reduce negative health and mental health outcomes. In this chapter, the six stages of PST—problem orientation, problem definition, solution generation, decision-making, solution implementation, and outcome evaluation—are explained and exemplified via vignettes. Areas for which problem-solving therapy has been found useful are summarized, including depression, anxiety, relationship difficulties, and distress related to medical problems such as cancer and diabetes. The chapter describes contexts for practice, including primary care and home care, as well as adaptations for the use of PST with older adults. Finally, a case example of a problem-solving intervention with an unemployed depressed older man is presented to illustrate this approach.

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Problem-Solving Therapy (PST)

(For resources, this is the publication date. For programs, this is the date posted.)


Visit the the  National Network of PST Clinicians, Trainers, & Researchers  for training options and resources. Also see the  archived NREPP listing .

Visit the the  National Network of PST Clinicians, Trainers, & Researchers .

Problem-Solving Therapy (PST) is a brief psychosocial treatment for patients experiencing depression and distress related to inefficient problem-solving skills. The PST model instructs patients on problem identification, efficient problem-solving, and managing associated depressive symptoms.

While there are different types of PST, they are all based on the same principle of resolving depression by re-engaging the client in active problem-solving and activities. In general, PST involves the following seven stages: (1) selecting and defining the problem, (2) establishing realistic and achievable goals for problem resolution, (3) generating alternative solutions, (4) implementing decision-making guidelines, (5) evaluation and choosing solutions, (6) implementing the preferred solutions, and (7) evaluating the outcome. A primary focus is learning and practicing PST skills, which are centered around empowering patients to learn to solve problems on their own.

Overall, the number of PST sessions may range from between 4 and 12. Individual sessions are, on average, 40 minutes long; however, group sessions can last up to 90 minutes. Each PST session follows a typical structure of agenda-setting, reviewing progress, engaging in the PST model problem-solving activities, reviewing action plans, and wrap-up.

PST can be used in wide range of settings and patient populations, including adaptations for those in primary care and those who are homebound, medically ill, and elderly. It can be delivered by a variety of providers, including mental health professionals, social workers, and health professionals, including primary care physicians and nurses.

Designation as a “Program with Evidence of Effectiveness”

SPRC designated this intervention as a “program with evidence of effectiveness” based on its inclusion in SAMHSA’s National Registry of Evidence-Based Programs and Practices (NREPP). 

Outcome(s) Reviewed (Evidence Rating)*

  • Suicidal Thoughts and Behaviors (Effective)
  • Depression and Depressive Symptoms (Effective)
  • Self-Concept (Effective)
  • Social Competence (Promising)
  • Self-Regulation (Promising)
  • Non-Specific Mental Health Disorders and Symptoms (Promising)
  • Physical Health Conditions and Symptoms (Ineffective)
  • General Functioning and Well-being (Ineffective)
  • Anxiety Disorders and Symptoms (Ineffective)

Read more about the  program’s ratings .


* NREPP changed its review criteria in 2015. This program was reviewed under the post-2015 criteria. To help practitioners find programs that fit their needs, NREPP reviews the evidence for specific outcomes, not overall programs. Each outcome was assigned an evidence rating of Effective, Promising, or Ineffective. A single program may have multiple outcomes with different ratings.  When considering programs, we recommend (a) assessing whether the specific outcomes achieved by the program are a fit for your needs; and (b) examining the strength of evidence for each outcome.

2012 NSSP Objectives Addressed: 

Objective 8.3: Promote timely access to assessment, intervention, and effective care for individuals with a heightened risk for suicide.

Book cover

Encyclopedia of Geropsychology pp 1874–1883 Cite as

Problem-Solving Therapy

  • Sherry A. Beaudreau 2 , 3 , 4 ,
  • Christine E. Gould 2 , 5 ,
  • Erin Sakai 6 &
  • J. W. Terri Huh 6 , 7  
  • Reference work entry
  • First Online: 01 January 2017

92 Accesses

Behavioral intervention; Skills-based therapy; Treatment

Problem-solving therapy (PST), developed by Nezu and colleagues, is a non-pharmacological, empirically supported cognitive-behavioral treatment (D’Zurilla and Nezu 2006 ; Nezu et al. 1989 ). The problem-solving framework draws from a stress-diathesis model, namely, that life stress interacts with an individual’s predisposition toward developing a psychiatric disorder. The driving model behind PST posits that individuals who experience difficulty solving life’s problems or coping with stressors of everyday living struggle with psychiatric symptoms more often than individuals considered as good problem solvers. This psychological treatment teaches a step-by-step approach to the process of identifying and implementing adaptive solutions for daily problems. By teaching individuals to solve their problems more effectively and efficiently, this model assumes that their stress and related psychiatric symptoms will...

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Alexopoulos, G. S., Kiosses, D. N., Heo, M., Murphy, C. F., Shanmugham, B., & Gunning-Dixon, F. (2005). Executive dysfunction and the course of geriatric depression. Biological Psychiatry, 58 (3), 204–210.

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Problem-solving training as an active ingredient of treatment for youth depression: a scoping review and exploratory meta-analysis

  • Karolin R. Krause   ORCID: orcid.org/0000-0003-3914-7272 1 , 2 ,
  • Darren B. Courtney   ORCID: orcid.org/0000-0003-1491-0972 1 , 3 ,
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Problem-solving training is a common ingredient of evidence-based therapies for youth depression and has shown effectiveness as a versatile stand-alone intervention in adults. This scoping review provided a first overview of the evidence supporting problem solving as a mechanism for treating depression in youth aged 14 to 24 years.

Five bibliographic databases (APA PsycINFO, CINAHL, Embase, MEDLINE, Web of Science) and the grey literature were systematically searched for controlled trials of stand-alone problem-solving therapy; secondary analyses of trial data exploring problem-solving-related concepts as predictors, moderators, or mediators of treatment response within broader therapies; and clinical practice guidelines for youth depression. Following the scoping review, an exploratory meta-analysis examined the overall effectiveness of stand-alone problem-solving therapy.

Inclusion criteria were met by four randomized trials of problem-solving therapy (524 participants); four secondary analyses of problem-solving-related concepts as predictors, moderators, or mediators; and 23 practice guidelines. The only clinical trial rated as having a low risk of bias found problem-solving training helped youth solve personal problems but was not significantly more effective than the control at reducing emotional symptoms. An exploratory meta-analysis showed a small and non-significant effect on self-reported depression or emotional symptoms (Hedges’ g = − 0.34; 95% CI: − 0.92 to 0.23) with high heterogeneity. Removing one study at high risk of bias led to a decrease in effect size and heterogeneity (g = − 0.08; 95% CI: − 0.26 to 0.10). A GRADE appraisal suggested a low overall quality of the evidence. Tentative evidence from secondary analyses suggested problem-solving training might enhance outcomes in cognitive-behavioural therapy and family therapy, but dedicated dismantling studies are needed to corroborate these findings. Clinical practice guidelines did not recommend problem-solving training as a stand-alone treatment for youth depression, but five mentioned it as a treatment ingredient.


On its own, problem-solving training may be beneficial for helping youth solve personal challenges, but it may not measurably reduce depressive symptoms. Youth experiencing elevated depressive symptoms may require more comprehensive psychotherapeutic support alongside problem-solving training. High-quality studies are needed to examine the effectiveness of problem-solving training as a stand-alone approach and as a treatment ingredient.

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Depressive disorders are a common mental health concern in adolescence [ 1 , 2 , 3 ] and associated with functional impairment [ 4 ] and an increased risk of adverse mental health, physical health, and socio-economic outcomes in adulthood [ 5 , 6 , 7 , 8 ]. Early and effective intervention is needed to reduce the burden arising from early-onset depression. Several psychotherapies have proven modestly effective at reducing youth depression, including cognitive-behavioural therapy (CBT) and interpersonal therapy (IPT) [ 9 , 10 ]. Room for improvement remains; around half of youth do not show measurable symptom reduction after an average of 30 weeks of routine clinical care for depression or anxiety [ 11 ]. One barrier to greater impact is a lack of understanding of which treatment ingredients are most critical [ 12 , 13 ]. Identifying the “active ingredients” that underpin effective approaches, and understanding when and for whom they are most effective is an important avenue for enhancing impact [ 13 ]. Distilling interventions to their most effective ingredients while removing redundant content may also help reduce treatment length and cost, freeing up resources to expand service provision. Given that youth frequently drop out of treatment early [ 14 ], introducing the most effective ingredients at the start may also help improve outcomes.

One common ingredient in the treatment of youth depression is problem-solving (PS) training [ 15 ]. Problem solving in real-life contexts (also called social problem solving) describes “the self-directed process by which individuals attempt to identify [ …] adaptive coping solutions for problems, both acute and chronic, that they encounter in everyday living” (p.8) [ 16 ]. Within a relational/problem-solving model of stress and well-being, mental health difficulties are viewed as the result of maladaptive coping behaviours that cannot adequately safeguard an individual’s well-being against chronic or acute stressors [ 17 ]. According to a conceptual model developed by D’Zurilla and colleagues ([ 16 , 17 , 18 , 19 ]; see Fig.  1 ), effective PS requires a constructive and confident attitude towards problems (i.e., a positive problem orientation ), and the ability to approach problems rationally and systematically (i.e., rational PS style ). Defeatist or catastrophizing attitudes (i.e., a negative problem orientation ), passively waiting for problems to resolve (i.e., avoidant style ), or acting impulsively without thinking through possible consequences and alternative solutions (i.e., impulsive/careless style ) are considered maladaptive [ 16 , 18 , 20 ]. Empirical studies suggest maladaptive PS is associated with depressive symptoms in adolescents and young adults [ 21 , 22 , 23 , 24 , 25 ].

figure 1

Dimensions of Problem-Solving (PS) Ability

Problem-Solving Therapy (PST) is a therapeutic approach developed by D’Zurilla and Goldfried [ 26 ] in the 1970s, to alleviate mental health difficulties by improving PS ability. Conceptually rooted in Social Learning Theory [ 27 ], PST aims to promote adaptive PS by helping clients foster an optimistic and self-confident attitude towards problems (i.e., a positive problem orientation), and by helping them develop and internalize four core PS skills: (a) defining the problem; (b) brainstorming possible solutions; (c) appraising solutions and selecting the most promising one; (d) implementing the preferred solution and reflecting on the outcome ([ 16 , 17 , 18 , 19 ]; see Fig. 1 ). PST is distinct from Solution-Focused Brief Therapy (SFBT), which has different conceptual roots and emphasizes the construction of solutions over the in-depth formulation of problems [ 28 ].

PS training is also a common ingredient of other psychosocial depression treatments [ 15 , 20 ], such as CBT and Dialectical Behaviour Therapy (DBT) [ 15 , 29 , 30 , 31 , 32 ] that typically focus on strengthening PS skills rather than problem orientation [ 20 ]. In IPT, PS training focuses on helping youth understand and resolve relationship problems [ 29 , 30 , 33 , 34 ]. PS training is also a common component of family therapy [ 35 ], cognitive reminiscence therapy [ 36 ], and adventure therapy [ 37 ]. The extent to which PS training in these contexts follows the conceptual model by D’Zurilla and colleagues varies. Hereafter, we will use the term PST (“Problem-Solving Therapy”) where problem-solving training constitutes a stand-alone intervention; and we will use the term “PS training” where it is mentioned as a part of other therapies or discussed more broadly as an active ingredient of treatment for youth depression.

Meta-analyses considering over 30 randomized control trials (RCTs) of stand-alone PST for adult depression suggest it is as effective as CBT and IPT, and more effective than waitlist or attention controls [ 38 , 39 , 40 ]. PST has been applied with children, adolescents, and young adults [ 41 , 42 , 43 , 44 , 45 , 46 ], but dedicated manuals for different developmental stages are not readily available. In an assessment of fit between evidence-based therapy components and everyday coping skills used by school children, PS skills were the third most frequently endorsed skill set in terms of frequency of habitual use and perceived effectiveness, suggesting these skills are highly transferable and relevant to youth [ 47 ]. PS training can be brief (i.e., involve fewer than 10 sessions) [ 38 ], and has been delivered to youth by trained clinicians [ 45 ], lay counsellors [ 46 ], and via online platforms [ 44 ]. It can also be adapted for primary care [ 40 ]. In light of its versatility and of its effectiveness in adults, PS training is a prime candidate for a treatment ingredient that deserves greater scrutiny in the context of youth depression. However, no systematic evidence synthesis has yet examined its efficacy and effectiveness in this population.

This study had two sequential parts. First, we conducted a mixed-methods scoping review to map the available evidence relating to PS training as an active ingredient for treating youth depression. Youth were defined as aged 14 to 24 years, broadly aligning with United Nations definitions [ 48 ]. In a subsequent step, we conducted an exploratory meta-analysis to examine the overall efficacy of free-standing PST, based on clinical trials identified in the scoping review.

Scoping review

Scoping review methodology was used to provide an initial overview of the available evidence [ 49 ]. The review was pre-registered on the Open Science Framework [ 50 ] and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) extension for Scoping Reviews checklist [ 51 ] (Additional File  1 ). The review was designed to integrate four types of literature: (a) qualitative studies reporting on young people’s experiences with PS training; (b) controlled clinical trials testing the efficacy of stand-alone PST; (c) studies examining PS-related concepts as predictors, moderators, or mediators of treatment response within broader therapeutic interventions (e.g., CBT); and (d) clinical practice guidelines (CPGs) for youth depression. In addition, the search strategy included terms designed to identify relevant conceptual articles that are discussed here as part of the introduction [ 52 ].

Search strategy

Five bibliographic databases (APA PsycINFO, CINAHL, Embase, MEDLINE, Web of Science) and the grey literature were systematically searched for (a) empirical studies published from database inception through June 2020, and (b) CPGs published between 2005 and July 2020. Reference lists of key studies were searched manually, and records citing key studies were searched using Google Scholar’s “search within citing articles” function [ 52 ]. The search strategy was designed in collaboration with a research librarian (SB) and combined topic-specific terms defining the target population (e.g., “depression”; “adolescent?”) and intervention (e.g., “problem-solving”) with methodological search filters combining database-specific subject headings (e.g., “randomized controlled trial”) and recommended search terms. The search for CPGs built upon a previous systematic search [ 53 , 54 ], which was updated and expanded to cover additional languages and databases. A multi-pronged grey literature search retrieved records from common grey literature databases and CPG repositories, websites of relevant associations, charities, and government agencies. The search strategy is provided in Additional File  2 .

Inclusion and exclusion criteria

Empirical studies were included if the mean participant age fell within the eligible range of 14 to 24 years, and at least 50% of participants showed above-threshold depressive or emotional symptoms on a validated screening tool. Controlled clinical trials had to compare the efficacy or effectiveness of PST as a free-standing intervention with a control group or waitlist condition. Secondary analyses were considered for their assessment of PS ability as a predictor, moderator, or mediator of treatment response if they reported on data from controlled clinical trials of broader therapy packages. Records were included as CPGs if labelled as practice guidelines, practice parameters, or consensus or expert committee recommendations, or explicitly aimed to develop original clinical guidance [ 53 , 54 ]; and if focused on indicated psychosocial treatments for youth depression (rather than prevention, screening, or pharmacological treatment). Doctoral dissertations were included. Conference abstracts, non-controlled trials, and prevention studies were excluded. Language of publication was restricted to English, French, German, and Spanish.

All records identified were imported into the EPPI-Reviewer 4.0 review software [ 55 ], and underwent a two-stage screening process (Fig.  2 ). Title and abstract screening was conducted in duplicate for 10% of the identified records, yielding substantial inter-rater agreement ( kappa  = .75 and .86, for empirical studies and CPGs, respectively). Of studies retained for full text screening, 20% were screened in duplicate, yielding substantial agreement ( kappa  = .68 and .71, for empirical studies and CPGs, respectively). Disagreements were resolved through discussion.

figure 2

PRISMA Flow Chart of the Study Selection Process

Data extraction and synthesis

Data were extracted using templates tailored to each literature type (e.g., the Cochrane data collection form for RCTs). Information extracted included: citation details; study design; participant characteristics; and relevant qualitative or quantitative results. Additional information extracted from CPGs included the issuing authority, the target population, the treatment settings to which the guideline applied, and any recommendations in relation to PS training. Data from clinical trials and secondary analyses were extracted in duplicate, and any discrepancies were discussed and resolved. Data synthesis followed a five-step process of data reduction, display, comparison, conclusion drawing, and verification [ 56 ]. Scoping review findings were summarized in narrative format. In addition, effect sizes reported in PST trials for depression severity were entered into an exploratory meta-analysis (see below).

The Centre for Addiction and Mental Health (CAMH) implements a Youth Engagement Initiative that brings the voices of youth with lived experience of mental health difficulties into research and service design [ 57 , 58 , 59 ]. Two youth partners were co-investigators in this review and consulted with a panel of twelve CAMH youth advisors to inform the review process and help contextualize findings. Formal approval by a Research Ethics Board (REB) was not required, as youth were research partners rather than participants.

To incorporate a variety of perspectives, the review team convened for an inference workshop where emerging review findings and feedback from youth advisors were discussed and interpreted. The multidisciplinary team involved a methodologist; two child and adolescent psychiatrists with expertise in CBT, DBT, and IPT; a psychologist with expertise in parent-adolescent therapy; a research librarian; a family doctor; a biostatistician; a clinical epidemiologist; two youth research partners; and a youth engagement coordinator.

Exploratory Meta-analysis

Although meta-analyses are not typical components of scoping reviews [ 60 ], an exploratory meta-analysis was conducted following completion of the scoping review and narrative synthesis, to obtain an initial indication of the efficacy of stand-alone PST based on the clinical trials identified in the review. The PICO statement that guided the meta-analysis is shown in Table  1 .

Quality assessment

Risk of bias for included PST trials was appraised using the Cochrane Collaborations Risk of Bias (ROB) 2 tool [ 61 ]. Ratings were performed independently by two reviewers (KRK and MA), and consensus was formed through discussion. In addition, a Grading of Recommendations Assessment, Development, and Evaluation (GRADE) appraisal was conducted (using the GRADEpro software; [ 62 ] to characterize the quality of the overall evidence. The evidence was graded for risk of bias, imprecision, indirectness, inconsistency, and publication bias [ 63 ]. A GRADE of “high quality” indicates a high level of confidence that the true effect lies close to the estimate; “moderate quality” indicates moderate confidence; “low quality” indicates limited confidence; and “very low quality” indicates very little confidence in the estimate. ROB ratings and GRADE appraisal results are provided in Additional File  6 .

Statistical analysis

The meta-analysis was conducted using the meta suite of commands in Stata 16.1. Effect sizes (Hedges’ g) and their confidence intervals were calculated based on the mean difference in depression severity scores between the PST and control conditions at the first post-treatment assessment [ 64 ]. Hedges’ g is calculated by subtracting the post-treatment mean score of the intervention group from the score of the control group, and by dividing the mean difference by the pooled standard deviation. Effect sizes between g = 0.2 and 0.5 indicate a small effect; g = 0.5 to 0.8 indicates a moderate effect; and g ≥ 0.8 indicates a large effect. Effect sizes were adjusted using the Hedges and Olkin small sample correction [ 64 ]. Pooled effect sizes were computed using a random effects model to account for heterogeneity in intervention settings, modes of delivery, and participant age and depression severity. The I 2 statistic was computed as an indicator of effect size heterogeneity. Higgins et al. [ 65 ] suggest that an I 2 below 30% represents low heterogeneity while an I 2 above 75% represents substantial heterogeneity. Investigations of heterogeneity are unlikely to generate valuable insights in small study samples, with at least ten studies recommended for meta-regression [ 65 ]. We conducted limited exploratory subgroup analysis by computing a separate effect size after excluding studies with high risk of bias. We inspected the funnel plot and considered conducting Egger’s test to examine the likelihood and extent of publication bias [ 66 ].

Selection and inclusion of studies

The search for empirical studies identified 563 unique records (Fig. 2 ), of which 148 were screened in full. Inclusion criteria were met by four RCTs of free-standing PST and four secondary analyses of clinical trials investigating PS-related concepts as predictors, mediators, or moderators of treatment response. No eligible qualitative studies that explicitly examined youth experiences of PS training were identified. The search for CPGs identified 9691 unique records, of which 41 were subject to full text screening, and 23 were included in the review. Below we present scoping review findings for all literature types, followed by the results from the meta-analysis for stand-alone PST trials.

Clinical trials of PST

Characteristics of the included PST trials are shown in Table  2 . Studies were published between 2008 and 2020 and included 524 participants (range: 45 to 251), with a mean age of 16.7 years (range: 12–25; 48% female). Participants had a diagnosis of major depressive disorder (MDD; k  = 1), elevated anxiety or depressive symptoms ( k  = 1), or various mild presenting problems including depression ( k  = 2). Treatment covered PS skills but not problem orientation (i.e., youth’s problem appraisals) and was delivered face to face ( k =  3) or online ( k  = 1) in five to six sessions. PST was compared with waitlist controls ( k  = 2), PS booklets ( k =  1), and supportive counselling ( k  = 1). Risk of bias was rated as medium for two [ 44 , 45 ], and high for one study [ 43 ] due to concerns about missing outcome data and the absence of a study protocol.

Eskin and colleagues [ 43 ] randomized 53 Turkish high school and university students with MDD to six sessions of PST or a waitlist. The study reports a significant treatment effect on self-reported depressive symptoms (d = − 1.20; F [1, 42] = 10.3, p  < .01.), clinician-reported depressive symptoms (d = − 2.12; F [1, 42] = 37.7, p  < .001), and recovery rates, but not on self-reported PS ability (d = − 0.46; F [1, 42] = 2.2, p  > .05). Risk of bias was rated as high due to 37% of missing outcome data in the control group and the absence of a published trial protocol.

Michelson and colleagues [ 46 ] compared PST delivered by lay counsellors in combination with booklets, to PS booklets alone in 251 high-school students with mild mental health difficulties (53% emotional problems) in low-income communities in New Delhi, India. At six weeks, the intervention group showed significantly greater progress towards overcoming idiographic priority problems identified at baseline (d = 0.36, p  = .002), but no significant difference in self-reported mental health difficulties (d = 0.16, p  = .18). Results were similar at 12 weeks, including no significant difference in self-reported emotional symptoms (d = 0.18, p  = .089). As there was no long-term follow-up, it is unknown whether reduced personal problems translated into reduced emotional symptoms in the longer term. Perceived stress at six weeks was found to mediate treatment effect on idiographic problems, accounting for 15% of the overall effect at 12 weeks.

Two trials found no significant effect of PST on primary or secondary outcomes: Hoek and colleagues [ 44 ] randomized 45 youth with elevated depression or anxiety symptoms to five sessions of online PST or a waitlist control; Parker and colleagues [ 45 ] randomized 176 youth with mixed presenting problems (54% depression) to either PST with physical activity or PST with psychoeducation, compared with supportive counselling with physical activity or psychoeducation [ 45 ]. Drop-out from PST was high in both studies, ranging from 41.4% [ 45 ] to 72.7% [ 44 ].

PS-related concepts as predictors, moderators, or mediators of treatment response

The review identified four secondary analyses of RCT data that examined PS-related concepts as predictors, moderators, or mediators of treatment response (see Table  3 , below). Studies were published between 2005 and 2014 and included data from 761 participants with MDD diagnoses, and a mean age of 15.2 years (range: 12–18; 61.2% female).

A secondary analysis of data from the Treatment for Adolescents with Depression Study (TADS, n  = 439) [ 79 ] explored whether baseline problem orientation and PS styles were significant predictors or moderators of treatment response to Fluoxetine, CBT, or a combination treatment at 12 weeks [ 70 ]. Negative problem orientation and avoidant PS style each predicted less improvement in depression symptom severity ( p  = .001 and p  = .003, respectively), while positive problem orientation predicted greater improvement ( p  = .002). There was no significant moderation effect. Neither rational PS style nor impulsive-careless PS style predicted or moderated change in depressive symptoms.

A secondary analysis of data from the Treatment of Resistant Depression in Adolescents (TORDIA) study [ 80 ] examined the impact of specific CBT components on treatment response at 12 weeks in youth treated with a selective serotonin reuptake inhibitor (SSRI) in combination with CBT ( n  = 166) [ 71 ]. Youth who received PS training were 2.3 times ( p  = .03) more likely to have a positive treatment response than those not receiving this component. A significant effect was also observed for social skills training (Odds Ratio [OR] = 2.6, p  = .04) but not for seven other CBT components. PS and social skills training had the most equal allocation ratios between youth who received them (52 and 54%, respectively) and youth who did not. Balanced allocation provides maximum power for a given sample size [ 81 ]. With allocation ratios between 1:3 and 1:5, analysis of the remaining seven components may have been underpowered. Of further note, CBT components were not randomly assigned but selected based on individual clinical needs. The authors did not correct for multiple comparisons as part of this exploratory analysis.

Dietz and colleagues [ 73 ] explored the impact of social problem solving on treatment outcome based on data from a trial comparing CBT and Systemic Behaviour Family Therapy (SBFT) with elements of PS training on the one hand, with Non-Directive Supportive Therapy on the other hand ( n  = 63). Both CBT and SBFT were associated with significant improvements in young people’s interpersonal PS behaviour (measured by coding videotaped interactions between youth and their mothers) over the course of treatment (CBT: b* = 0.41, p  = .006; SBFT: b* = 0.30, p  = .04), which in turn were associated with higher rates of remission (Wald z = 6.11, p  = .01). However, there was no significant indirect effect of treatment condition via youth PS behaviour, and hence, no definitive evidence of a formal mediation effect [ 82 ].

Kaufman and colleagues [ 72 ] examined data from a trial comparing an Adolescent Coping with Depression (CWD-A) group-based intervention with a life-skills control condition in 93 youth with comorbid depression and conduct disorder. The secondary analysis explored whether change in six CBT-specific factors, including the use of PS and conflict resolution skills, mediated the effectiveness of CWD-A. There was no significant improvement in PS ability in CWD-A, compared with the control, and hence no further mediation analysis was conducted.

PS training in clinical practice guidelines

We identified 23 CPGs from twelve countries relevant to youth depression (see Additional File  4 ), issued by governments ( k  = 6), specialty societies ( k  = 3), health care providers ( k  = 4), independent expert groups ( k  = 2), and others, or a combination of these. Of these 23 CPGs, 15 mentioned PS training in relation to depression treatment for youth, as a component of CBT ( k  = 7), IPT ( k  = 4), supportive therapy or counselling ( k  = 3), family therapy ( k  = 1), DBT ( k  = 1), and psychoeducation ( k  = 1).

None of the reviewed CPGs recommended free-standing PST as a first-line treatment for youth depression. However, five CPGs mentioned PS training as a treatment ingredient or adjunct component in the context of recommending broader therapeutic approaches. The World Health Organization’s updated Mental Health Gap Action Programme guidelines recommended PS training as an adjunct treatment (e.g., in combination with antidepressant medication) for older adolescents [ 83 ]. A guideline by Orygen (Australia) suggested that for “persistent sub-threshold depressive symptoms (including dysthymia) or mild to moderate depression”, options should include “6–8 sessions of individual guided self-help based on the principles of CBT, including behavioural activation and problem-solving techniques” [ 84 ]. The Chilean Ministry of Health recommended supportive clinical care with adjunctive psychoeducation and PS tools, or supportive counselling for individuals aged 15 and older with mild depression (p. 52) [ 85 ]. The Cincinnati Children’s Hospital Medical Centre recommended four to eight sessions of supportive therapy for mild or uncomplicated depression, highlighting “problem solving coping skills” as one element of supportive therapy (p. 1) [ 86 ]. Fifth, the American Academy of Child and Adolescent Psychiatry’s 2007 practice parameter suggested each phase of treatment for youth depression should include psychoeducation and supportive management, which might include PS training (p. 1510) [ 87 ]. CPGs did not specify whether PS training should incorporate specific modules, or whether the term was used loosely to describe unstructured PS support.


Each of the four RCTs of free-standing PST identified by the scoping review contributed one comparison to the exploratory meta-analysis of overall PST efficacy (see Fig.  3 ). Self-rated depression or emotional symptom severity scores were reported by all four studies and constituted the primary outcome for the meta-analysis. We conducted additional exploratory analysis for clinician-rated depression severity as reported in two studies [ 43 , 45 ]. The pooled effect size for self-reported depression severity was g = − 0.34 (95% CI: − 0.92 to 0.23). Heterogeneity was high ( I 2  = 88.37%; p  < .001). Due to the small number of studies included, analysis of publication bias via an examination of the funnel plot and tests of funnel plot asymmetry could not be meaningfully conducted [ 88 , 89 ]. The funnel plot is provided in Additional File  5 for reference (Fig. S3).

figure 3

Forest Plot: Random Effects Model with Self-Reported Depression or Emotional Symptoms as Primary Outcome (Continuous)

To achieve the best possible estimate of the true effect size and reduce heterogeneity we computed a second model excluding the one study with high risk of bias (i.e., [ 43 ]). The resulting effect size was g = − 0.08 (95% CI: − 0.26 to 0.10), with no significant heterogeneity ( I 2  = 0.00%; p  = 0.72; see Fig. S1 in Additional File 5 ). The pooled effect size for clinician-rated depression severity was g = − 1.39 with a wide confidence interval (95% CI: − 4.03 to 1.42) and very high heterogeneity ( I 2  = 97.41%, p  < 0.001; see Fig. S2 in Additional File 5 ).

Overall quality of the evidence

According to the GRADE assessment, the overall quality of the evidence was very low, with concerns related to risk of bias, the inconsistency of results across studies, the indirectness of the evidence with regards to the population of interest (i.e., only one trial focused exclusively on youth with depression), and imprecision in the effect estimate (Table S4 in Additional File 6 ).

This scoping review aimed to provide a first comprehensive overview of the evidence relating to PS training as an active ingredient for treating youth depression. The evidence base relating to the efficacy of PST as a stand-alone intervention was scarce and of low quality. Overall, data from four trials suggested no significant effect on depression symptoms. The scoping review identified some evidence suggesting PS training may enhance treatment response in CBT. However, this conclusion was drawn from secondary analyses where youth were not randomized to treatment with and without PS training, and where primary studies were not powered to test these differences. Disproportionate exposure to comparator CBT components also limits these findings. PST was not recommended as a stand-alone treatment for youth depression in any of the 23 reviewed CPGs; however, one guideline suggested it could be provided alongside other treatments for older adolescents, and four suggested PS training as a component of low-intensity psychosocial interventions for youth with mild to moderate depression.

Given the limited evidence base, only tentative suggestions can be made as to when and for whom PS training is effective. The one PST trial with a low risk of bias enrolled high-school students from low-income communities in New Delhi, and found that PST delivered by lay counselors in combination with PST booklets was more effective at reducing idiographic priority problems than booklets alone, but not at reducing mental health symptoms [ 46 ]. Within a needs-based framework of service delivery (e.g., [ 90 ]), PST may be offered as a low-intensity intervention to youth who experience challenges and struggle with PS—including in low-resource contexts. Future research could explore whether PS training might be particularly helpful for youth facing socioeconomic hardship and related chronic stressors by attenuating potentially harmful impacts on well-being [ 91 ]. If findings are promising, PS training may be considered for targeted prevention (e.g., [ 42 ]). However, at this time there is insufficient evidence to support PS training on its own as an intervention aimed at providing symptom relief for youth experiencing depression.

The PST manual suggests cognitive overload, emotional dysregulation, negative thinking and hopelessness can interfere with PS [ 16 ]. Youth whose depression hinders their ability to engage in PST may require additional support through more comprehensive therapy packages such as CBT or IPT with PS training. In the TORDIA study [ 80 ], where PS training was found to be one of the most effective components, it was generally taught alongside cognitive restructuring, behavioural activation, and emotion regulation, which may have facilitated youths’ ability to absorb PS training [ 71 ]. The focus of these other CBT components on changing negative cognitions and attributions may fulfil a similar function as problem orientation modules in stand-alone PST. Research that is powered to explore such mechanisms is needed. Future research should also apply methodologies designed to identify the most critical elements in a larger treatment package (e.g., dismantling studies; or sequential, multiple assignment, randomized trials) to examine the role of PS training when delivered alongside other components. While one trial focusing on CBT components is currently underway [ 92 ], similar research is needed for other therapies (e.g., IPT, DBT, family therapy).

The included PST trials provided between five and six sessions and covered PS skills but not problem orientation. Meta-analyses of PST for adult depression suggest treatment effectiveness may be enhanced by longer treatment duration (≥ 10 sessions) [ 38 ], and coverage of problem orientation alongside PS skills [ 39 ]. As per the PST treatment manual, strengthening problem orientation fosters motivation and self-efficacy and is an important precondition for enhancing skills [ 93 , 94 ]. In addition, only one youth PST trial assessed PS ability at baseline [ 43 ]. A meta-analysis of PST for adult depression [ 39 ] suggests that studies including such assessments show larger effect sizes, with therapists better able to tailor PST to individual needs. Future research should seek to replicate these findings specifically for youth depression.

Drop out from stand-alone PST was high in two out of four studies, ranging from 41.4% [ 45 ] to 72.7% [ 44 ]. Since its development in the 1970s, PST has undergone several revisions [ 16 , 93 , 95 , 96 , 97 ] but tailoring to youth has been limited. To contextualize the review findings, the review team consulted a panel of twelve youth advisors at the Centre for Addiction and Mental Health (without sharing emerging findings so as not to steer the conversation). Most had participated in PS training as part of other therapies, but none had received formal PST. A key challenge identified by youth advisors was how to provide PS training that is universally applicable and relevant to different youth without being too generic, rigid or schematic; and how to accommodate youth perspectives, complex problems, and individual situations and dispositions. Youth advisors suggested reviewing and reworking PS training with youth in mind, to ensure it is youth-driven, strengths-based, comprehensive, and personalized (see Fig. S4 in Additional File  7 for more detail). Youth advisors emphasized that PS training should identify the root causes underpinning superficial problems and address these through suitable complementary intervention approaches, if needed.

Solution-focused brief therapy (SFBT) has emerged as an antithesis to PST where more emphasis is given to envisaging and constructing solutions rather than analysing problems [ 28 ]. This may be more consistent with youth preferences for strengths-based approaches but may provide insufficiently comprehensive problem appraisals. Future research should compare the effectiveness and acceptability of PST and SFBT and consider possible benefits of combining the advantages of both approaches, to provide support that is strengths-based and targets root problems. More generally, given the effectiveness of PST in adults, future studies could examine whether there are developmental factors that might contribute to reduced effectiveness in youth and should be considered when adapting PST to this age group.

Strengths and limitations

This scoping review applied a broad and systematic approach to study identification and selection. We searched five bibliographic databases, and conducted an extensive grey literature search, considering records published in four languages. Nevertheless, our search may have missed relevant studies published in other languages. We found only a small number of eligible empirical studies, several of which were likely underpowered. As stated above, studies analysing PS-related concepts as predictors, moderators, or mediators of treatment response within broader therapies were heterogenous and limited by design and sample size constraints.

Similarly, there was heterogeneity in recruitment and intervention settings, age groups, and delivery formats across the four RCTs of stand-alone PST, and the overall quality of the evidence was very low. As reflected in our GRADE appraisal, one important limitation was the indirectness of the available evidence: Only one PST trial focused specifically on youth with an MDD diagnosis, while the remaining three included youth with a mix of mental health problems. Although outcomes were reported in terms of depression or emotional symptom severity, this was not based on a subgroup analysis focused specifically on youth with depression. Impact on this group may therefore have been underestimated. In addition, the only PST trial with a low risk of bias did not administer a dedicated depression symptom scale. Instead, our exploratory meta-analysis included scores from the 5-item SDQ emotional problems subscale, which assesses unhappiness, worries, clinginess, fears, and somatic symptoms—and may not have captured nuanced change in depression severity [ 98 , 99 ]. Other concerns that led us to downgrade the quality of the evidence related to considerable risk of bias, with only one out of four studies rated as having a low risk; and imprecision with several studies involving very small samples. Due to the small number of eligible studies, it was not possible to identify the factors driving treatment efficacy via meta-regression. The long-term effectiveness of PS training, or the conditions under which long-term benefits are likely to be realized also could not be examined [ 38 ].

PS training is a core component of several evidence-based therapies for youth depression. However, the evidence base supporting its efficacy as a stand-alone treatment is limited and of low quality. There is tentative evidence suggesting PS-training may drive positive outcomes when provided alongside other treatment components. On its own, PS training may be beneficial for youth who are not acutely distressed or impaired but require support with tackling personal problems. Youth experiencing moderate or severe depressive symptoms may require more comprehensive psychotherapeutic support alongside PS training, as there is currently no robust evidence for the ability of free-standing PST to effectively reduce depression symptoms.

High-quality trials are needed that assess PST efficacy in youth with mild, moderate, and severe depression, in relation to both symptom severity and idiographic treatment goals or priority problems. These studies should examine the influence of treatment length and module content on treatment impact. Dedicated studies are also needed to shed light on the role of PS training as an active ingredient of more comprehensive therapies such as CBT, DBT, IPT, and family therapy. Future studies should include assessments of adverse events and of cost effectiveness. Given high drop-out rates in several youth PST trials, it is important to adapt PS training approaches and therapy manuals as needed, following a youth-engaged research and service development approach [ 57 ], to ensure their relevance and acceptability to this age group.

Availability of data and materials

All data generated or analysed during this study are included in this published article and its supplementary information files.


Avoidance style

Beck Depression Inventory

Centre for Addiction and Mental Health

Cognitive behavioural therapy

Children’s Depression Rating Scale—Revised

Center for Epidemiologic Studies Depression Scale

Clinical Global Impression Scale—Improvement

Cumulative Index to Nursing and Allied Health Literature

Clinical practice guideline

Adolescent Coping with Depression [intervention name]

Dialectical behaviour therapy

Grading of Recommendations Assessment, Development, and Evaluation

Impulsivity/Carelessness Style

Interpersonal psychotherapy

The Kiddie Schedule for Affective Disorders and Schizophrenia

Lifeskills training

Major depressive disorder

Medical Literature Analysis and Retrieval System Online

Negative problem orientation

Nondirective supportive therapy

Positive problem orientation

Preferred Reporting Items for Systematic Reviews and Meta-Analysis

  • Problem solving

Problem-solving training

Problem-Solving Therapy

Randomized controlled trial

Research ethics board

Risk of bias

Rational problem-solving style

Systemic Behaviour Family Therapy

Strengths and Difficulties Questionnaire

Solution-Focused Brief Therapy

Social Problem-Solving Inventory Revised

Selective serotonin reuptake inhibitors

Treatment for Adolescents with Depression Study

Treatment of Resistant Depression in Adolescents

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We would like to thank the members of the Centre for Addiction and Mental Health (CAMH) youth advisory group for their valuable insights and suggestions. The systematic search for clinical practice guidelines presented in this review was based on a search strategy developed by Dr. Kathryn Bennett. We would like to thank Dr. Bennett for agreeing to the reuse of the strategy as part of this review. We would also like to thank the Cundill Centre for Child and Youth Depression for providing institutional support to this project.

This work was funded by a Wellcome Trust Mental Health Priority Area “Active Ingredients” commission awarded to KRK, DBC and PS, and the Centre for Addiction and Mental Health, Toronto, Canada.

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Karolin R. Krause, Darren B. Courtney, Sarah Bonato, Madison Aitken, Jacqueline Relihan, Matthew Prebeg, Karleigh Darnay, Lisa D. Hawke, Priya Watson & Peter Szatmari

Evidence Based Practice Unit, University College London and Anna Freud National Centre for Children and Families, London, UK

Karolin R. Krause

Department of Psychiatry, University of Toronto, Toronto, ON, Canada

Darren B. Courtney, Madison Aitken, Lisa D. Hawke, Priya Watson & Peter Szatmari

Independent Family Doctor, Toronto, ON, Canada

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KRK, DBC and PS formulated the research questions and designed the study. SB conducted the systematic search for clinical practice guidelines and the grey literature search, and advised on the search for retrieving empirical studies, which was led by KRK. KRK, DBC and BWCC performed the screening of records for inclusion criteria. Data extraction was performed by KRK and BWCC. The risk of bias assessment for included randomized control trials was conducted by KRK and MA. The youth consultation was led by JR, MP and KD with input from LDH and KRK. Data analysis was led by KRK. All authors contributed to the interpretation of emerging findings through an internal findings workshop and through several rounds of feedback on the draft manuscript, which was drafted by KRK. All authors have reviewed and approved the final manuscript.

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Correspondence to Karolin R. Krause .

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Supplementary Information

Additional file 1..

Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist.

Additional file 2.

Search Strategy.

Additional file 3.

List of Studies Included in the Scoping Review.

Additional file 4.

Characteristics of Included Clinical Practice Guidelines.

Additional file 5.

Additional Data and Outputs from the Meta-Analysis.

Additional file 6.

Risk of Bias Assessment and GRADE Appraisal.

Additional file 7.

Illustration of Insights from the Consultation of Youth Advisors.

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Krause, K.R., Courtney, D.B., Chan, B.W.C. et al. Problem-solving training as an active ingredient of treatment for youth depression: a scoping review and exploratory meta-analysis. BMC Psychiatry 21 , 397 (2021). https://doi.org/10.1186/s12888-021-03260-9

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DOI : https://doi.org/10.1186/s12888-021-03260-9

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problem solving therapy protocol

Comparative effectiveness of family problem-solving therapy (F-PST) for adolescents after traumatic brain injury: Protocol for a randomized, multicenter, clinical trial


  • 1 Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
  • 2 Department of Pediatrics and Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
  • 3 Case Western Reserve University and MetroHealth Medical Center, Cleveland Medical Center, Cleveland, OH, USA.
  • 4 Biobehavioral Health Center, Nationwide Children's Hospital Research Institute, The Ohio State University, Columbus, OH, USA.
  • 5 Case Western Reserve University, Rainbow Babies & Children's Hospital, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
  • 6 Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.
  • 7 Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.
  • PMID: 30023445
  • PMCID: PMC6046511
  • DOI: 10.1016/j.conctc.2018.04.001

Introduction: The objective of this manuscript is to describe the methodology that will be used to test the comparative effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI.

Methods: Three-arm comparative effectiveness, randomized clinical trial (RCT) design. We describe the protocol of a three-arm RCT comparing the effectiveness of three modalities of F-PST to reduce executive dysfunction and behavior problems following TBI in adolescence. The RCT will compare the relative effectiveness among face-to-face; online and self-directed; and therapist-supported online modes of treatment.

Ethics and dissemination: It is anticipated that findings from this work will inform future clinical care practices, with implications for treatment of other patient populations of youth with psychological symptoms arising from neurological conditions. Institutional review board approval will be obtained from all sites prior to commencement of the study.

Keywords: Behavior; Executive function; NCT:02368366; Pediatric traumatic brain injury; Problem solving; Telehealth.

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Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial

Roxanne c. keynejad.

1 Section of Women’s Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK

Tesera Bitew

2 College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia

3 Institute of Educational and Behavioural Science, Debre Markos University, Debre Markos, Ethiopia

Katherine Sorsdahl

4 Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa

Bronwyn Myers

5 Alcohol Tobacco and Other Drug Use Research Unit, South African Medical Research Council, Cape Town, South Africa

6 Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa

Simone Honikman

7 Perinatal Mental Health Project, Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa

Girmay Medhin

8 Aklilu-Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia

Negussie Deyessa

9 College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia

Nick Sevdalis

10 Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK

Wietse A. Tol

11 Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD USA

12 United States of America (USA) & Peter C. Alderman Program for Global Mental Health, HealthRight International, New York, New York, NY USA

Louise Howard

Charlotte hanlon.

13 Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK

14 World Health Organization Collaborating Centre for Mental Health Research and Capacity-Building, Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia

15 Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia

Associated Data

The minimum dataset used to calculate the study findings will be included with the study’s resultant outcome reporting manuscript as a supplementary file. Additional datasets generated during this study will be available from the corresponding author upon reasonable request.

In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women’s physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal depression and anxiety to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial.

Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes.

Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings.

Trial registration

Pan-African clinical trials registry: PACTR202002513482084 . Prospectively registered on 13 December 2019.


Background and rationale.

Intimate partner violence (IPV) refers to behaviour by a partner or ex-partner that causes (or has the potential to cause) physical, sexual or psychological harm. IPV includes physical aggression, sexual coercion, psychological abuse and controlling activity [ 1 ]. It is highly prevalent worldwide [ 2 ] and an important social determinant of physical and mental health [ 3 , 4 ]. In response, the World Health Organization (WHO) [ 5 ], the United Nations [ 6 ] and the World Psychiatric Association [ 7 – 9 ] have prioritised interventions to prevent and address IPV and its health impacts.

The relationship between IPV and mental health is bidirectional, such that IPV increases a woman’s risk of mental disorders, which in turn increases a woman’s vulnerability to (further) IPV. For example, IPV is associated with subsequent depressive symptoms, suicide attempts [ 10 ] and alcohol use disorders [ 11 ], which increase women’s risk for IPV (re)victimisation. Exposure to IPV is rarely assessed in randomised controlled trials (RCTs) of psychological interventions [ 12 ], but some studies have found reduced IPV alongside improved mental health [ 13 ] and birth outcomes [ 14 ].

There is limited evidence on mental health interventions tailored to the needs of pregnant women experiencing IPV [ 15 ], especially in low- and middle-income countries (LMICs). In a rapid review of evidence, 33 studies were identified that reported mental health interventions for women affected by IPV [ 16 ]. In most of these studies, the interventions were group-delivered cognitive behavioural therapy (CBT)-informed interventions, mind–body interventions (such as mindfulness-based stress reduction, yogic techniques and biofeedback) or individually delivered, trauma-focused psychotherapeutic interventions. Although all the identified studies came from high-income countries, protocols from Tanzania [ 17 ] and South Africa [ 18 ] indicated growing research interest in the African region. For example, one RCT in Nairobi, Kenya, has shown that five sessions of the multicomponent behavioural treatment Problem Management Plus (PM+) delivered to women with a history of any gender-based violence are associated with improved psychological distress and post-traumatic stress symptoms at 3-month follow-up compared with enhanced usual care [ 19 ].

A recent systematic review confirmed the paucity of intervention research addressing the mental health of both survivors and perpetrators of IPV in LMICs [ 20 ]; no studies replicated evaluations of previously studied interventions and none were conducted in low-income countries. The authors recommended strengthening the theoretical underpinnings of mental health interventions for people experiencing or perpetrating IPV, testing their impacts on hypothesised mediators and improving IPV detection using continuous outcome measures and fully powered samples. Treating depression and post-traumatic stress disorder (PTSD) has the potential to reduce self-blame, low self-esteem, hopelessness and emotional numbing, and improve communication, stress coping and anger management skills among both survivors and perpetrators [ 20 ].

We recently investigated whether IPV exposure moderates the efficacy of generic psychological interventions in LMICs. Our meta-analysis of 15 studies that provided data showed that women reporting IPV demonstrated greater improvements in anxiety symptoms than women not reporting IPV following generic psychological interventions (difference in standardised mean differences, 0.31; 95% confidence interval 0.04–0.57; I 2  49.3%) and consistent but non-significant differences in PTSD, depression and psychological distress symptom improvements [ 21 ]. Our systematic review only identified two RCTs of psychological interventions for depression or anxiety in LMICs which were tailored for women experiencing IPV. In Pakistan, ten sessions of IPV-adapted group CBT were associated with improved depression and anxiety compared with CBT-based self-help groups [ 22 ]. In Iran, 10–12 sessions of IPV-tailored narrative exposure therapy were associated with improved PTSD and depression at 3- and 6-month follow-up compared with treatment as usual (life skills training and supportive counselling) [ 23 ]. These studies support the potential benefits of adapting psychological interventions for depression, anxiety or PTSD to meet the needs and experiences of women affected by IPV.

Although PM+ has been shown to be effective for women experiencing gender-based violence in Nairobi [ 19 ], delivering five 90-min sessions may not be feasible in primary care settings in low-income countries. Problem solving therapy (PST) is a brief psychological intervention that aims to improve coping with life problems by teaching problem solving skills. A meta-analysis of PST for depression found a standardised mean effect size of 0.34, but high heterogeneity among included studies indicated the need for research to determine the settings and patient groups for whom PST is most effective [ 24 ]. A meta-analysis of PST for any mental or physical health problem found that it was significantly more effective than no treatment, treatment as usual, and ‘attention placebo’ arms (controlling for non-specific effects of contact), moderated by the use of problem orientation training and homework assignments [ 25 ].

Several studies from LMICs suggest that PST can be effective for treating depression, anxiety and psychological distress. A 5-week pilot study of adapted PST in English, Xhosa and Afrikaans in South African township residents found that it was acceptable, feasible and associated with significant reductions in psychological distress [ 26 ]. An RCT of South African emergency department attendees found that substance use was significantly reduced at 3-month follow-up in participants who received five sessions of blended PST and motivational interviewing, compared to motivational interviewing alone or psychoeducation control [ 27 ]. In Zimbabwe, the ‘Friendship Bench’ intervention comprised six sessions of individual PST delivered by lay health workers, and an optional six-session peer support group [ 28 ]. In this 86% female sample, depression and psychological distress were significantly reduced following PST in comparison to enhanced usual care.

The importance of designing RCTs to evaluate mediators of treatment and mechanisms of change is widely supported [ 29 ]. However, despite evidence of efficacy, studies of how PST works are limited and contradictory. Hypothesised mechanisms have included improving mastery, self-control and the accuracy of perceived problem severity [ 30 ], problem solving skills [ 31 ], ‘life integration’ [ 32 ] and locus of control (the extent to which the individual attributes their experiences to internal or external factors) [ 33 ]. An RCT comparing online CBT, PST and waiting list control for depression found that the effects of both interventions were mediated by reduced dysfunctional attitudes, worry, negativity towards problems and increased mastery, with no difference in effect sizes between CBT and PST [ 34 ]. The authors postulated that both interventions increase expectations of self-efficacy, leading to greater commencement and continuation of coping behaviours [ 35 ]. Both mechanisms for improved mood might also influence the ability of women to respond to IPV.

Process evaluations of complex intervention feasibility studies are increasingly recognised as being vital to optimise the safety, efficiency and validity of subsequent RCTs [ 5 , 36 ]. Updated guidance [ 37 ] and growing consensus [ 38 ] support the need for studies to determine the feasibility of research methods used to study complex interventions before conducting definitive RCTs. Sociocultural, health system and economic factors affect the adaptation, translation, mechanisms, success and scale-up of interventions, so a mixed-method process evaluation [ 39 ] is crucial and helps to inform understanding of the context for future implementation [ 40 ].

In rural Ethiopia, 72% of women are exposed to lifetime IPV [ 41 ] and this is associated with emotional distress [ 42 ] and depression [ 43 ]. IPV in Ethiopia is most prevalent during pregnancy [ 44 ] and increases the risk of child morbidity and mortality associated with maternal depression [ 45 ]. Antenatal depression in Ethiopia is associated with increased emergency presentations in pregnancy [ 46 ], perinatal complications [ 47 ], prolonged labour [ 48 ] and use of emergency delivery care [ 49 ]. As pregnancy is the most common time for Ethiopian women to access health care [ 50 ], antenatal care offers an important opportunity to provide an intervention that addresses both IPV and depression.

The range of cultural, geographical, economic, linguistic, religious, socio-political, health system and other differences between rural Ethiopia and the largely middle-income settings of most RCTs published to date supports the need for research evaluating PST adapted for women experiencing IPV (PST-IPV) in this context.

In this randomised feasibility trial and process evaluation of perinatal PST-IPV in rural Ethiopia, we aim to determine the feasibility and acceptability of the intervention and study design to inform a future fully powered RCT. Specific objectives are to:

  • Determine whether the PST-IPV intervention and processes of recruitment, randomisation, follow-up and evaluation are feasible and acceptable to pregnant women and health workers in rural Ethiopia. This includes estimating parameters to inform the design of a future RCT.
  • Refine the PST-IPV intervention and study design in response to a mixed-method process evaluation, which assesses the feasibility, acceptability, fidelity and quality of the intervention, explores causal mechanisms, and identifies contextual factors that may influence outcomes [ 37 ].

Trial design

In this three-arm feasibility trial, we will randomise eligible women (with depressive symptoms, functional impact and past-year IPV) to PST-IPV, standard PST or enhanced usual care (information about relevant sources of support). All arms represent additions to standard clinical care, which does not currently provide any routine interventions for perinatal depression or IPV.

This study is linked to a two-arm feasibility trial that will randomise eligible women (with depressive symptoms and functional impact) to standard PST or information only, the protocol of which is reported separately (Bitew T, Keynejad RC, Honikman S, Sorsdahl K, Myers B, Fekadu A, et al. Brief problem-solving therapy for perinatal depression in rural Ethiopia: protocol for a randomised feasibility study.) (see Fig.  1 ).

An external file that holds a picture, illustration, etc.
Object name is 13063_2020_4331_Fig1_HTML.jpg

Flow diagram of problem solving therapy (PST) adapted for pregnant women experiencing intimate partner violence (IPV) feasibility trial procedure, indicating the relationship with a nested feasibility trial of standard PST in women not reporting past-year IPV (shaded grey). ANC antenatal care, HEW health extension worker, MINI Mini-International Neuropsychiatric Interview, PHQ-9 Nine-item Patient Health Questionnaire

Study setting

The study will be conducted in selected health facilities in the predominantly rural areas of Gurage zone (projected population 1,712,506) and Silt’e zone (projected population 1,043,242) in the Southern Nations, Nationalities, and Peoples’ Region of Ethiopia [ 51 ]. Primary health care is structured so that the nurse, midwife and health officer-run health centres (serving a population of 25,000–40,000) are linked to five community health posts (serving a population of 3000–5000) staffed by one or two health extension workers (HEWs) each, with access to a single primary hospital for more specialist care. HEWs, who have completed high school and received 1 year of undergraduate-level training [ 52 ], provide a first antenatal contact before referring women for further antenatal care (ANC) at a health centre or primary hospital and maintain contact with women during pregnancy.

This study builds on the programme for improving mental health care (PRIME) study [ 53 ], which integrated mental health into primary and maternal care in five LMICs, including the Gurage zone, Ethiopia [ 54 ]. In PRIME, a district-level mental health plan was developed in collaboration with key stakeholders and comprised interventions at the community, health facility and health system level. At the facility level, PRIME trained primary and maternal care staff using the mental health gap action programme (mhGAP) intervention guide of the WHO, which guides non-mental health specialists through clinical diagnostic and treatment algorithms for prioritised mental, neurological and substance use disorders [ 55 ]. The PRIME study investigators identified low detection rates of depression, which may be related in part to a lack of acceptable treatment options. Formative work was therefore conducted to inform adaptation of a brief psychological intervention for depression. In a nested study, PST was then adapted for antenatal women in this rural Ethiopian setting.

A systematic review and meta-analysis [ 21 ], further qualitative interviews and theory of change workshops (Bitew T, Keynejad RC, Honikman S, Sorsdahl K, Myers B, Fekadu A, et al. Brief psychological intervention for antenatal depression: a qualitative study.) (Keynejad RC, Bitew T, Mulushoa A, Tol W, Howard LM, Hanlon C. Adapting brief, task-shared problem-solving therapy for women experiencing intimate partner violence in rural Ethiopia: a qualitative study.) were then used to adapt this locally tailored PST intervention to address the needs and experiences of women affected by IPV. The preliminary theory of change visualises health worker perspectives on the components, hypothesised mediators, intermediate and long-term outcomes of PST-IPV intervention, and factors anticipated to influence the delivery and implementation of PST-IPV (see Supplementary file  1 ).

Adaptation for IPV focused on international guidelines [ 5 ], which recommend identifying women experiencing IPV, training health care providers about IPV, and providing woman-centred care and support when IPV is disclosed. PST-IPV will apply a PST approach in the context of IPV, enabling IPV-related problem solving and management of mental health-related symptoms.

Participant sample size

As a feasibility trial, this study is not powered to detect intervention efficacy, but rather to estimate feasibility parameters to inform a future RCT, and test intervention and research protocols. With a total sample size of 75 (25 participants randomised to PST-IPV, 25 to PST and 25 to enhanced usual care), a drop-out rate of 30% can be estimated to within a 95% confidence interval of ±3%. To estimate the standard deviation of the primary feasibility outcome measure to inform a future RCT sample size calculation, recommended feasibility trial sample sizes range between a total of 24 and 50 across two arms [ 56 , 57 ].

Participant recruitment

Research staff will consult health care workers based in primary hospitals and/or health centres in Gurage and Silt’e zones to identify potentially eligible women meeting those inclusion criteria about which information is held for screening. Potentially eligible women will be approached through ANC clinics and HEW home visits by research staff and provided with written and verbal information in Amharic, before being invited to give written, informed consent to initial screening. Non-literate women will signify their consent by finger print. A high school-educated assistant will act as a witness to confirm that the information sheet has been read aloud correctly to non-literate women. Women screened as eligible to participate in the randomised feasibility trial will then be invited to give written, informed consent to participate. As with screening, non-literate women will signify their consent to participate in the trial by witnessed finger print.

Due to potential risks of abusive partners learning of women’s involvement, information sheets, consent forms and other study paperwork will be kept in the locked research office after being read and signed but will be accessible to women at their request. Due to logistical challenges affecting women’s daily lives in this setting, it is not possible to give prospective participants 24 h to decide whether to take part. However, a minimum of 30 min will be allowed for the woman to make up her mind about participating in the study.

Participant screening

Consecutive, potentially eligible women who provide informed consent will be screened for depressive symptoms and a history of past-year IPV after their ANC appointment. Depressive symptoms will be screened for using the locally validated [ 58 ] nine-item Patient Health Questionnaire (PHQ-9) [ 59 ]. To screen for IPV exposure, research staff will first read the introductory paragraph of the Amharic translated [ 60 ] Conflict Tactics Scale [ 61 ] to potential participants (or they may read themselves, if literate) to ameliorate stigma they may feel towards disclosing IPV. A five-item ‘non-graphic language’ screening test previously used in this and other LMIC contexts and found to be a valid measure of IPV [ 62 ] will then be administered. Finally, items from the WHO multi-country study [ 42 ] of women’s health and domestic violence, previously used in this setting, will be used to ask about experiences of IPV in the past year.

All screened women scoring five or more on the PHQ-9 [ 63 , 64 ] and endorsing any functional impact of symptoms (the tenth item) will be invited to participate in the research study. Endorsement of the tenth item will be defined as answering “somewhat”, “very” or “extremely difficult” to the question “over the last two weeks, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?”.

Consenting women who disclose any past-year IPV during screening will be randomised to one of PST-IPV, standard PST or enhanced usual care, whereas consenting women reporting no IPV on baseline measurements will be randomised to one of standard PST or enhanced usual care for the separate, nested PST feasibility trial (see Fig. ​ Fig.1 1 ).

Participant recruitment procedures

All women screened as eligible to participate will be informed about the study and given the opportunity to ask questions before being invited to consent to participate in the randomised feasibility trial. Women consenting to participate will first receive their routine clinical care and then participate in a baseline interview using fully structured questionnaires. If screening or this assessment identify any sources of concern (e.g. suicidal ideation, risks to herself or others), the researcher will discuss these with the woman and explain the need to share them with her health care professional, before involving them. To be eligible to participate in the PST-IPV components of the overall study, women must meet the eligibility criteria (see below).

Participant eligibility criteria

Women can be included if they:

  • Speak Amharic (the official regional language)
  • Are aged 16 years or over
  • Are between 12 and 34 weeks gestation of pregnancy
  • Are intending to reside in the study area for the duration of the study
  • Score 5 or more on PHQ-9 with functional impairment (tenth question)
  • Report IPV in the past year (in a current or previous relationship) during screening
  • Consent to participate, including to accept enhanced usual care or to attend four sessions of PST-IPV or PST (if randomised to a treatment arm)

Women are required to speak Amharic, the official language of the region, so that they can access all translated study materials, verbally or in writing. Relationships are defined as any romantic or sexual interaction within or outside marriage.

PHQ-9 has been validated in the study area in both primary care [ 63 ] and ANC attendees (area under the receiver operating characteristic curve 0.91, 95% confidence interval 0.86–0.96) [ 64 ]. For primary care attendees a score of five or more was the optimal cut-off for identifying possible depressive disorder. For antenatal women, a cut-off of four or more was optimal. However, since at the optimal cut-offs the positive predictive value was less than 50%, in this study women scoring above the cut-off (five or more) will be included if they also report difficulty in their day-to-day activities (measured using the PHQ-9 tenth item).

Participant exclusion criteria

Women will be excluded if they:

  • Are acutely unwell
  • Require emergency treatment
  • Are identified by the ANC provider during pre-screening as having possible psychotic symptoms
  • Are unable to understand the interview (e.g. diagnosed with severe intellectual disability or dementia, or unable to speak Amharic)
  • Expect to move away from the study area before the study is completed

All women endorsing question nine of PHQ-9 about suicidal thoughts or self-harm behaviours will receive the Amharic [ 63 ] Mini-International Neuropsychiatric Interview suicidality scale [ 65 ]. Women scoring 17 or above on the Mini-International Neuropsychiatric Interview (indicating high suicide risk) will be excluded from participation as part of a stepped-care model [ 54 ]. They will be referred instead to a mental health-trained primary care worker who will employ mhGAP [ 55 ] criteria to assess for imminent risk of self-harm or suicide. Women assessed as being at imminent risk will be referred to a psychiatric nurse in the primary hospital for escalation of their care. The attendance of participants at referred appointments will be facilitated by the study, including any attendant transportation costs to access off-site services. Any psychotic symptoms and risks identified during the trial will be discussed with the project mental health professional and women will be referred for specialist mental health care if required. Women assessed as eligible to participate at the time of screening but who do not consent to take part will receive the same stepped mental health care model, depending on their symptoms and any imminent risks.

Otherwise eligible women reporting no past-year IPV exposure will be invited to participate in the separate, nested feasibility trial of standard PST for depression but will not be eligible for this study of PST-IPV.

Participant consent

Interested women who cannot read will be read aloud the information sheet. If unable to write, participants will record a thumb print, signed by a literate witness (a high school-educated assistant) after confirming that the information sheet has been read aloud correctly; otherwise, participants will provide written informed consent. Study documents will be kept in the locked research office but will be accessible to women at their request. The information sheet includes details of how participants can access compensation, if required.

Participant reimbursement

All participants will be reimbursed for their time attending research interviews in addition to transport costs and any additional expenses incurred. Participants will be reimbursed for transport costs to attend PST or PST-IPV sessions but will not be compensated for their time during these sessions. This is to determine the acceptability of psychological intervention sessions to women and enable calculation of drop-out rates. A fund will be available to assist participants disclosing IPV who wish to access support services (for example. to facilitate transport to a government social support office or police station).

Randomisation and allocation to trial arms

Research staff will telephone the Centre for Innovative Drug Development and Therapeutic Trials for Africa data manager, based at the College of Health Sciences, Addis Ababa University, Ethiopia, who is not otherwise involved in this study, to allocate each participant to a study arm (PST-IPV, standard PST or enhanced usual care) using a random number list generated by the trial statistician (GM), who is not otherwise involved in data collection processes. The data manager will telephone a separate member of research staff based in Silt’e, who will inform a clinician trained to deliver PST-IPV or standard PST when a new participant has been allocated to that trial arm. Research staff will provide participants with an unmarked card indicating their enrolment in the trial and agree a date and time to attend their first session of PST-IPV or standard PST. When they attend, they will be expected by their allocated clinician. For participants allocated to enhanced usual care, their antenatal care provider will provide them with information about sources of support and the research assistant will arrange a follow-up appointment 9 weeks later.

Women who do not attend their appointed date and time will be contacted using the telephone number (where applicable) and/or household details they have provided at trial enrolment or through their allocated HEW, up to a maximum of three attempts.

Given qualitative differences between PST and PST-IPV, clinicians delivering the intervention cannot be masked to participant allocation. To avoid contamination, PST-IPV, standard PST and enhanced usual care will be delivered by different practitioners who have either attended a PST-IPV or a standard PST training course, or received basic training to provide enhanced usual care. Post-intervention outcome assessments will be conducted by trained, independent assessors (working in separate offices from practitioners delivering interventions and not travelling together) masked to intervention allocation, with a minimum post-high school diploma level of education. Independent assessors will document any incidents of unmasking. Data analysts will also be masked to intervention allocation.

Intervention arms

Participants randomised to PST-IPV or standard PST will attend four intervention contacts within a maximum of 8 weeks. Where birth occurs before the end of treatment, the feasibility of continuing PST-IPV or standard PST post-natally will also be assessed.

Both manualised interventions will be delivered by trained health workers, such as nurses and midwives, supervised by Psychology Masters-level qualified research staff, with access to a project mental health professional for clinical concerns. Responses to concerns and risk incidents will follow standard operating procedures (SOPs). Government-employed health workers trained to deliver the interventions will be paid for their time.

Both PST-IPV and standard PST intervention arms follow the same structure of four sessions, based on the model successfully employed in South Africa and adapted for this rural Ethiopian setting [ 27 , 66 ]. Session 1 focuses on basic psychoeducation, introduction to PST, identifying the most important things in the woman’s life and categorising problems into three groups. Session 2 focuses on revising session 1, coping strategies for ‘group A’ problems (which are upsetting but do not influence the most important things in the woman’s life) and the six-step problem solving method for ‘group C’ problems (which are important and can be solved). Session 3 focuses on revising session 2, coping strategies for ‘group B’ problems (which are important but cannot be solved) and psychoeducation about the phases of coping with bereavement and loss. Session 4 focuses on revising session 3, using problem solving skills in everyday life and reviewing how the coping strategies worked in practice. All sessions involve assigning and reviewing take-home activities.

PST-IPV content and materials are adapted to address the needs and experiences of women affected by IPV, whilst standard PST content and materials are generic. Adaptations for women experiencing IPV include training staff using content and materials from the new WHO curriculum on caring for women subjected to violence [ 67 ], attention to safety and sensitivity where women list IPV-related problems during sessions (including training with worked examples of problem solving focused on IPV), and adaptation of PST case studies to reflect common problems associated with IPV.

Participants randomised to PST-IPV or standard PST will attend a total of six contacts: one baseline pre-intervention research assessment, four intervention contacts and a follow-up research assessment contact 9 weeks after recruitment. The feasibility of follow-up 9 weeks after recruitment will be assessed and may change, depending on gestation of pregnancy at the time of enrolment.

Enhanced usual care arm

One-third of participants will be randomised to information only about sources of support (enhanced usual care; see Supplementary file  2 ). They will attend two contacts: one pre-intervention assessment at which they are provided with information about relevant sources of support, and one follow-up assessment 9 weeks later.

In our meta-analysis we found that randomisation of control group participants with depression, anxiety, PTSD or psychological distress symptoms and IPV exposure to waiting list, treatment as usual, or enhanced usual care arms is widespread [ 21 ]. This, coupled with the lack of any standard intervention provision for perinatal depression and/or IPV in rural Ethiopia and the provision of safeguards in the study design, justify the use of a control arm, which comprises enhanced usual care (provision of information about sources of support).

Measurement: participants

Women will be assessed at baseline and then 9 weeks later in a private room of the health care facility at a time convenient to them (Fig.  2 ). During these assessments, fully structured measures will be administered to consenting participants in an interview format. The time taken to complete planned questionnaires will be tested prior to commencing the study. Where administration of study measures takes longer than 1 h per session or is experienced by research staff or participants as unduly burdensome, instruments will be removed from the assessment questionnaire. This information will contribute to the study’s process evaluation.

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Schedule of participant enrolment, interventions and assessments. CSRI client service receipt inventory, GAD-7 Generalised Anxiety Disorder 7 scale, IPV intimate partner violence, MINI Mini-International Neuropsychiatric Interview, OSSS-3 Oslo Social Support Scale 3, PCL-5 post-traumatic stress disorder checklist for Diagnostic and Statistical Manual version 5, PHQ-9 Nine-item Patient Health Questionnaire, PST problem solving therapy, PTSD post-traumatic stress disorder, WHO World Health Organization, WHODAS World Health Organization Disability Assessment Schedule

Primary participant outcome

At baseline and the independent, masked, 9-week follow-up interview, depression symptoms will be measured using the Amharic-translated PHQ-9 [ 59 ], a nine-item questionnaire asking about the presence of depressive symptoms in the preceding 2 weeks. Each item is rated according to persistence of the symptom (0 = not at all, 1 = several days, 2 = more than half of the days, 3 = nearly every day). PHQ-9 scores pre- and post-participation will be compared to calculate the mean difference in depression symptom reduction in PST-IPV, standard PST and enhanced usual care arms. Proportions of participants showing a treatment response, defined as a 50% reduction in PHQ-9 score, will also be calculated, although this feasibility trial will not be powered to detect treatment efficacy.

Secondary participant outcomes

At baseline and 9-week follow-up, the following will be measured using Amharic-translated scales. If scores are normally distributed, mean differences will be compared between arms using t tests and, if not normally distributed, median differences will be compared between arms using non-parametric statistical tests.

  • Post-traumatic stress symptoms using the PTSD checklist for the Diagnostic and Statistical Manual version 5 (PCL-5) [ 68 ] which has been adapted for a rural Ethiopian context
  • Anxiety symptoms using the Generalised Anxiety Disorder 7 (GAD-7) scale [ 69 ]
  • Disability using the 12-item Ethiopian adaptation [ 70 ] of the WHO Disability Assessment Schedule (WHODAS 2.0) [ 71 ]
  • IPV: participants will be asked about past-month IPV at baseline and 9-week follow-up to determine whether the frequency of different types of IPV (physical, sexual, psychological, coercive control) change during the study period
  • Self-efficacy using an adapted self-efficacy scale validated in Ethiopia for sexual health research [ 72 ]
  • Mastery (the extent to which the person considers themselves in control of forces affecting their lives in important ways [ 73 ]) using a 15-item multi-cultural mastery scale [ 74 ] adapted for rural, non-Western communities
  • Perceived social support using the Oslo Social Support Scale 3 (OSSS-3) [ 75 ] previously used in this region in a study of antenatal depressive symptoms [ 46 ]
  • Health care-seeking behaviour using the client service receipt inventory [ 76 ] adapted for Ethiopia [ 77 ] and modified to focus on the past month; the client service receipt inventory will be used to quantify the frequency of primary health care visits, inpatient admissions, private sector (including traditional healer) contacts, medications and investigations of women in each arm, in the past month, pre- and post-participation
  • Adverse events or unanticipated harms taking place during the study period
  • Obstetric and neonatal outcomes: HEWs, who maintain maternal care records, will report the location of birth and any stillbirths and early neonatal deaths among study participants, attendance at subsequent ANC appointments and medication prescriptions for physical and mental health, as they are not reliably self-reported [ 47 ]; where women attend ANC at a combination of HEW health posts, health centres and/or primary hospitals, antenatal contacts at all relevant services will be collected; the feasibility of collecting this data will be explored during analysis
  • Attitudes towards gender roles using the WHO Attitudes Towards Gender Roles questionnaire [ 42 ]

Measurement: process evaluation

Assessing parameters and feasibility for a future trial.

The mixed-method process evaluation will assess variables associated with intervention implementation processes. Recommended intervention process outcomes (for implementation) include acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration and sustainability [ 78 ]. In this feasibility trial, we will focus on evaluating:

  • Acceptability of PST-IPV and of the study design to women and health workers in terms of uptake, completion and drop-out rates
  • Adoption by health workers
  • Appropriateness from women and health workers’ perspectives
  • Feasibility in terms of practical organisation
  • Fidelity of delivery

The following administrative data will be collected, which will inform the feasibility outcome measures shown in brackets:

  • Screening rates and reasons for refusal (acceptability)
  • Recruitment rates (acceptability, feasibility)
  • Numbers of eligible women at each clinical site (appropriateness)
  • Proportions of eligible women agreeing to participate (acceptability)
  • Willingness to be randomised and comprehension by participants of randomisation (acceptability of allocation)
  • Session duration (appropriateness, feasibility, fidelity)
  • Take-home activity completion (acceptability, fidelity, appropriateness)
  • Drop-out rates (acceptability, feasibility)
  • Follow-up rates (feasibility of retention)

Research staff will document key site features to enable comparison of process data, and keep field journals noting:

  • Staff willingness to participate at each site and retention in the study (acceptability, adoption, appropriateness, feasibility)
  • Optimal recruitment procedures (feasibility)
  • Acceptance of randomisation at each site (acceptability, appropriateness, feasibility)

Qualitative interviews

The acceptability and burden on women and staff of the intervention itself (including which components are experienced as helpful or unhelpful), randomisation, outcome measures and follow-up will be assessed through qualitative interviews with a purposively sampled sub-group of approximately six women (three per intervention arm) and six staff (three per intervention arm). Interviews will also explore feasibility and acceptability of the study’s SOP, which dictates the management of safety, confidentiality and ethical concerns, risk disclosures during sessions and research contacts. Interviews will be conducted in Amharic by research staff who did not have extended contact with participants during the trial in a private location convenient to them. Participants will be compensated for their time, and interviews will be audio-recorded, transcribed and translated into English.

Intervention fidelity and supervision

Health workers trained to deliver PST-IPV and standard PST will receive monthly supervision with a local psychiatric nurse. Health workers will audio-record PST-IPV and standard PST sessions with the participant’s consent for review by their supervisor and to inform discussions of challenging cases during supervision sessions.

A random sample of these audio recordings will be evaluated using the ENACT scale [ 79 ] to assess therapist competence (quality) alongside supervisor observations and therapist logs. ENACT has been adapted for the Ethiopian context and has been shown to be reliably administered by trained clinicians [ 80 ].

Recordings will also be evaluated for intervention fidelity and session completion using a checklist of session components. Supervision records and therapist logs will also be reviewed for intervention fidelity and contamination between arms [ 27 ]. The frequency and duration of IPV-specific content during recorded sessions of both PST-IPV and standard PST documented in therapist logs will also be noted to determine the extent to which participants raise and explore IPV-related problems during sessions. The quality of therapist–client rapport will be assessed using the Amharic-translated helping alliance questionnaire [ 81 ], which has been tested in this setting [ 82 ].

Outcome assessors will receive supervision from a Psychology Masters-qualified supervisor. Supervision logs will include discussing any items which are poorly understood or completed, and reviewing the time taken for outcome assessment to assess its acceptability and feasibility.

Statistical analysis

We will follow the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials [ 83 ].

We will review process evaluation data for indications of sub-group differences in uptake, recruitment and retention of participants by site, health worker, recruitment method/site, participant (age, education level, religion, parity) and health worker characteristics (age, profession, years of experience). Quantitative scale results will be analysed using STATA [ 84 ].

Feasibility studies are not powered to calculate effect sizes but standard deviations and drop-out rates will be calculated on the intention-to-treat sample (all women who were randomised, regardless of uptake of the intervention) to inform sample size calculation for a future RCT, for outcome measures, recruitment rates and drop-out rates. Quantitative process data will determine future RCT design improvements, such as session number and duration, recruitment, outcome measures, and strategies preventing contamination. The extent of missing data will be evaluated as part of the process evaluation. For clinical outcome measures, missing data will not be imputed. Rather, standard deviations will be calculated using data from participants for whom outcome measures are available.

We will apply the framework approach to thematic analysis of qualitative interviews [ 85 ] and triangulate the results with quantitative process data through researcher meetings. The full descriptive analysis will include contextual barriers and facilitators influencing study outcomes.

Ethical considerations

Strategies to ensure data protection, quality assurance and dissemination of results are outlined in Supplementary file  3 and data collection forms are provided in Supplementary file  4 . Ethical approval has been provided by the Institutional Review Board of the College of Health Sciences, Addis Ababa University, Ethiopia (protocol number: 032/19/CDT) and the Psychiatry, Nursing & Midwifery subcommittee of King’s College London’s College Research Ethics Committee, UK (reference: HR-18/19–9230); see Supplementary file  5 .

This study involves recruitment of potentially vulnerable women, disclosure of IPV, and detecting depression, anxiety and PTSD symptoms. The SOP therefore outlines actions to mitigate potential risks. If participants disclose current exposure to IPV, research staff will be trained to listen non-judgementally, offer privacy and confidentiality, and information about local agencies who can provide assistance (see Supplementary file  2 ) [ 42 ] in keeping with WHO guidelines, irrespective of the study arm.


Female research staff will be carefully selected with the sensitivity of subject matter in mind. Once recruited, they will receive locally tailored IPV training [ 44 ]. When approaching women, great sensitivity will be exercised. In all cases, care will be taken to ensure that women do not feel pressurised to participate. We will ensure anonymity of interview transcripts and any quotations used in publications or reports.

The SOP outlines measures to mitigate potential risks to participants, including abusive partners learning of their involvement. These include a protocol for responding to concerns or disclosures of risk, emergency contact information, conduct when communicating with vulnerable participants, documenting and responding to serious adverse events and reporting them to the King’s College London and Addis Ababa University institutional review boards which have provided ethical approval for this trial. Numbers of serious adverse events will be calculated per trial arm. A data monitoring committee will not be instituted due to the small sample size of this feasibility trial, which is not powered for interim analyses.

Risk of harm

The risk of harm to participants will be minimised by providing full information about the study prior to voluntary participation. Participants are free to withdraw from taking part at any time without needing to give a reason. Their individual data can be withdrawn from the randomised feasibility trial until the final data collection, at which point analysis will commence.

Some participants might become distressed when speaking about their mental health or experiences of IPV. Questions will be asked and worded sensitively to minimise this occurring during research assessments. During sessions of PST-IPV, the opportunity to express emotion about problems and difficulties may be therapeutic, however. Clinicians will be trained in responding to distress. Data collectors will be trained to be sensitive to signs of distress and when to suggest rescheduling or discontinuing an interview. If the participant remains distressed, the data collector will contact their supervisor and arrange appropriate support. If needed, women can be referred to their ANC provider, who has been trained in primary mental health care and the situation can be discussed with the project mental health professional.

Despite being an important social determinant of physical and mental health, there is limited evidence for brief, task-shared psychological interventions adapted to address the mental health needs of women experiencing IPV in LMICs. Interventions tailored to the specific LMIC context and adapted to address the experiences of women affected by IPV require development, evaluation and implementation. This randomised feasibility trial comparing PST-IPV with standard PST and enhanced usual care in rural Ethiopia and mixed-methods process evaluation will determine feasibility and acceptability to women and health workers to inform the design of a future RCT. It will generate hypotheses, explore causal mechanisms and contextual factors relevant to mental health clinicians, researchers and implementation scientists in primary care and ANC in LMICs, which can be investigated across contexts in a future, fully powered multi-centre RCT.

Strengths and challenges

This is the first study of its kind in this rural Ethiopian setting. Most research into psychological interventions for anxiety and depression in LMICs comes from urban or peri-urban areas of middle-income countries, and only two to date have been adapted for women experiencing IPV [ 22 , 23 ]. Neither of these interventions trialled a brief intervention, embedded within ANC in a rural, low-income country setting. The results will be informative to researchers developing brief psychological interventions adapted for this and other resource-restricted settings.

This three-arm randomised feasibility trial benefits from a shared control group with a separate, nested study of standard PST. The efficiency of shared control groups is well documented [ 86 ] and multi-arm trials are recognised for their simplicity, speed and reduced cost relative to two-arm trials [ 87 ]. The study focus on evaluating and refining the feasibility of both the PST-IPV intervention and the study design using a mixed-method process evaluation ensures that improvements will be made prior to a definitive RCT.

The sensitivity of discussing mental health and IPV, logistical challenges to women’s participation in research, limited education and literacy and competing priorities on ANC staff time are all anticipated challenges to the successful completion of this study. These will be mitigated by stringent ethical conduct emphasising confidentiality and supporting women at risk of IPV, supporting women to access intervention arms, adapting recruitment and intervention procedures to accommodate variable education and comprehensive training and supervision of health workers. However, unforeseen geopolitical eventualities may arise in rural, low-income settings which compromise the conduct and completion of this protocol as planned. The benefit of this feasibility trial is to identify study design problems as early as possible in order to mitigate their impact on the resultant research evidence.

Trial status

This is protocol version 1.0. This trial was prospectively registered on the Pan-African clinical trials registry (PACTR202002513482084) on 13 December 2019. Recruitment of participants has not yet commenced. Recruitment of participants is anticipated to complete by 31 December 2020. Any proposed changes to the protocol will be submitted to King’s College London and Addis Ababa University ethics review boards and updated on the pan-African clinical trials registry. Research staff will inform trial participants, where required, and changes will be discussed in the ultimate results publication. The trial sponsor is King’s College London, De Crespigny Park, Denmark Hill, London SE5 8AF, UK.

Supplementary information

Abbreviations, authors’ contributions.

All authors contributed to the development of this protocol, reviewed drafts of this paper and approved the final manuscript. RCK led the conception, writing up and ethics applications for this study, which is a core part of her PhD research. TB collaborated on the study design process and led the conception of the linked, related feasibility trial described in this protocol, which is outlined in detail in a separate, linked protocol submission. KS collaborated on the adaptation of PST and its materials for perinatal depression in rural Ethiopia, and on the adaptation of PST for women experiencing IPV (PST-IPV). BM collaborated on the adaptation of PST and its materials for perinatal depression in rural Ethiopia, and on the adaptation of PST for women experiencing IPV (PST-IPV). SH commented on drafts of this protocol and suggested amendments to the study design. NS collaborated on the implementation of science elements of the study design process and commented on drafts of the protocol. GM commented on drafts of this protocol and suggested amendments to the study design. ND commented on drafts of this protocol and suggested amendments to the study design. LH supervised the development of this protocol, study design and ethics applications, commented on drafts and provided input to this study from its inception. CH supervised the development of this protocol, study design and ethics applications, commented on drafts and provided input to this study from its inception. WAT commented on drafts of this protocol and suggested amendments to the study design.

RCK, CH, LH and NS are supported by the National Institute of Health Research (NIHR) Global Health Research Unit on Health System Strengthening in sub-Saharan Africa (ASSET), King’s College London (GHRU 16/136/54) using UK aid from the UK Government. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. RCK is supported by a King’s Institute of Psychiatry, Psychology & Neuroscience Clinician Investigator Scholarship for her PhD. CH and KS receive additional support from AMARI as part of the DELTAS Africa Initiative (DEL-1501) funded by the Wellcome Trust. LH is in receipt of an NIHR Senior Investigator award. TB receives support from AMARI as part of the DELTAS Africa Initiative (DEL-1501) funded by the Wellcome Trust as part of his post-doctoral work. BM is supported through jointly funded research grant funding from the Department for International Development, the Economic and Social Research Council, and Wellcome Trust (MR/M014290/1; MR/M011464/1) as well as the South African Medical Research Council. SH is supported by research grant funding from Bill and Melinda Gates Foundation OPP1179252 through her contribution to the Kilkari Impact Evaluation Project in India. The research of NS is supported by the NIHR Applied Research Collaboration (ARC) South London at King’s College Hospital NHS Foundation Trust. NS is a member of King’s Improvement Science, which offers co-funding to the NIHR ARC South London and comprises a specialist team of improvement scientists and senior researchers based at King’s College London. Its work is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), Guy’s and St Thomas’ Charity and the Maudsley Charity. The research of NS is supported by the ASPIRES research programme in LMICs (Antibiotic use across Surgical Pathways—Investigating, Redesigning and Evaluating Systems), funded by the Economic and Social Research Council. RCK had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funders played no role in the study design, data collection, data analysis, data interpretation, or report writing.

Availability of data and materials

Ethics approval and consent to participate.

Ethical approval has been provided by the Institutional Review Board of the College of Health Sciences, Addis Ababa University, Ethiopia (protocol number: 032/19/CDT) and the Psychiatry, Nursing & Midwifery subcommittee of King’s College London’s College Research Ethics Committee, UK (reference: HR-18/19–9230); see Supplementary file  5 . Any protocol amendments will be communicated with both boards and updated on the pan-African clinical trials registry. Informed consent will be obtained from all study participants.

Consent for publication

Not applicable.

Competing interests

NS is the director of London Safety and Training Solutions, which provides advisory and training services in safety and quality improvement to hospitals and health care organisations globally on a consultancy basis. The remaining authors declare that they have no competing interests.

Publisher’s Note

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Contributor Information

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Supplementary information accompanies this paper at 10.1186/s13063-020-04331-0.

  • Study protocol
  • Open Access
  • Published: 18 September 2019

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial

  • Rachana Parikh 1 , 2   na1 ,
  • Daniel Michelson 3   na1 ,
  • Kanika Malik 1 ,
  • Sachin Shinde 1 ,
  • Helen A. Weiss 4 ,
  • Adriaan Hoogendoorn 5 , 6 ,
  • Jeroen Ruwaard 5 , 6 ,
  • Madhuri Krishna 1 ,
  • Rhea Sharma 1 ,
  • Bhargav Bhat 1 ,
  • Rooplata Sahu 1 ,
  • Sonal Mathur 1 ,
  • Paulomi Sudhir 7 ,
  • Michael King 8 ,
  • Pim Cuijpers 9 ,
  • Bruce F. Chorpita 10 ,
  • Christopher G. Fairburn 11 &
  • Vikram Patel 1 , 12  

Trials volume  20 , Article number:  568 ( 2019 ) Cite this article

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Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial.


We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9–12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions.

An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding.

Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems.

Trial registration

Both trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).

Peer Review reports

Adolescence is a critical period for the prevention and treatment of mental health problems. Around 10% of adolescents experience a mental disorder [ 1 ] and about half of all mental disorders have their onset by the mid-teens, rising to three-quarters by the mid-20s [ 2 ]. Effective early intervention is therefore vital to mitigate the substantial personal, familial, and societal costs of mental disorders [ 3 ]. Low- and middle-income countries (LMICs) are home to 90% of the world’s 1.3 billion adolescents, but there is a severe shortage of mental health services targeting this age group in most LMICs [ 4 ]. This includes India, which is home to one-fifth of the global population of adolescents. Resource constraints are compounded by low demand for mental health care and the scarcity of context-specific evidence on the effectiveness of interventions [ 5 ]. Although a robust body of research testifies to the treatability of adolescent mental disorders, mainly through psychological interventions such as cognitive behavioral therapy (CBT), the bulk of such evidence originates from high-income countries [ 6 ]. Generalizability of the existing evidence base to LMICs is further restricted by the widespread use of specialist providers in intervention trials, with supervision often provided directly by program developers [ 7 ].

Transdiagnostic approaches have been advocated as a means of providing more scalable psychological interventions [ 8 ], with emerging evidence (mainly from adult populations) supporting their use in LMICs [ 9 , 10 ]. Transdiagnostic interventions recognize the considerable overlap that exists in the constituent elements of disorder-specific protocols and the abundance of shared risk and protective factors for psychopathology in general [ 11 ]. The available data suggest that transdiagnostic interventions may be comparable in effectiveness to their disorder-specific counterparts, although head-to-head comparisons are scarce [ 12 ]. There are also indications that transdiagnostic protocols may confer advantages in terms of improved efficiencies afforded by the parsimonious use of a single intervention framework for multiple problems [ 13 ], as well as meeting an expressed need among practitioners for therapies that are designed to fit ‘real-world’ settings where psychosocial complexity and comorbidity are commonplace [ 14 ].

The PRIDE (PRemIum for aDolEscents) research program involves linked studies in India with the goal to design and evaluate a scalable transdiagnostic intervention model that addresses common mental health problems (i.e., anxiety, depression, and conduct difficulties) in school-going adolescents. The public health importance of adolescent mental health has been recognized in the National Adolescent Health Program (the Rashtriya Kishor Swasthya Karyakram) [ 15 ]. PRIDE was initiated in response to these national and global priorities, and challenges, for improving the quality and coverage of adolescent mental health interventions. The process of aligning the global evidence base on youth psychotherapies with local evidence followed recommendations from an earlier research program (PREMIUM) on psychological intervention development in low-resource settings, which led to the design and demonstration of the clinical effectiveness of two brief psychological treatments for adult mental health problems [ 16 , 17 , 18 ].

Our formative and pilot studies have informed the design of a stepped-care architecture involving two interventions of incremental intensity [ 19 , 20 , 21 , 22 ]. The current trial protocol focuses on the first step: a low-intensity problem-solving intervention designed for delivery by non-specialist school counsellors. Problem solving is strongly represented in the global literature, where it is among the most commonly used practice elements in evidence-based mental health programs for children and adolescents [ 23 , 24 ]. It has been applied successfully as the main element in other low-intensity psychological interventions in LMICs [ 25 , 26 ]. The emphasis on problem solving also reflects the primacy of psychosocial factors in adolescents’ narratives around explanatory models of distress and help-seeking [ 21 ]. Our provisional theory of change for the intervention draws on evidence-based principles of stress and coping [ 27 ], such that the impact of an ecological stressor is assumed to be mediated by appraisals of the stressor and of the repertoire of available coping resources. Our problem-solving intervention can be considered transdiagnostic in the sense that a single procedure is assumed to have generalized benefits for a diversity of clinical presentations. Non-responders to this first-line intervention will be offered a more intensive and dynamic transdiagnostic treatment incorporating additional cognitive and behavioral procedures. The effectiveness of the second step will be evaluated in a separate randomized trial for which participants will be recruited from a different school cohort.

As well as shaping the design of the two intervention steps, formative and pilot work suggested a need for awareness generation around the topics of mental health and psychological help-seeking. We therefore developed a sensitization plan to address factors such as low mental health literacy and confidentiality concerns, which might otherwise impede the demand for school mental health services. In so doing, we noted the lack of consistent evidence for the effects of school-based and other youth-focused mental health sensitization interventions. Existing approaches have varied considerably in their design and intensity [ 28 , 29 ] and their ability to increase demand from adolescents for mental health care has yet to be established [ 30 , 31 ]. We therefore identified an opportunity to test an additional component of the PRIDE intervention architecture—a classroom sensitization session led by school counsellors—by embedding a recruitment trial within a host intervention trial [ 32 ]. Where applicable, the distinctive features of the two trials are presented sequentially, structured according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [ 33 ]. Shared features of the two trials (e.g., data management) are presented under unified headings.

Objectives and hypotheses

Embedded recruitment trial.

The primary objective of this stepped-wedge, cluster randomized controlled trial is to evaluate the impact of a classroom sensitization session (intervention condition), over and above school-level sensitization activities (control condition), on the rate of referred adolescents (i.e., the proportion of adolescents referred as a function of the total sampling frame in each condition) into the host trial. The primary hypothesis is that the classroom-level sensitization intervention will be associated with a higher referral rate into the host trial compared with referrals arising from school-level sensitization activities in isolation. The secondary hypotheses are that, compared with the control condition, the intervention condition will be associated with a greater proportion of referred students who meet eligibility criteria for inclusion in the host trial (Table  1 ) and a greater proportion of students who self-refer. We will also explore whether there are any differences between conditions in terms of the severity of total symptoms and symptom subtypes presented by referred adolescents.

The primary objective of this two-armed, parallel-design, individually randomized controlled trial is to evaluate the effectiveness of a low-intensity, problem-solving intervention (intervention arm) in reducing adolescent-reported mental health symptoms and idiographic problems at 6 weeks post-randomization, compared with enhanced usual care (control arm), for adolescents with common mental health problems. The primary hypothesis is that the problem-solving intervention will be superior to the control arm in reducing the severity of adolescent-reported mental health symptoms and idiographic problems at 6 weeks post-randomization.

The secondary objectives are:

To evaluate the effectiveness of the intervention on adolescent-reported distress/functional impairment, perceived stress, mental wellbeing, and clinical remission

To explore whether a theoretically informed a priori factor (perceived stress at 6 weeks) mediates the effects of the intervention on mental health symptoms and idiographic problems at 12 weeks

To explore the effectiveness of the intervention on caregiver-reported adolescent mental health symptoms, associated distress/functional impairment, and adolescent-reported prosocial behavior

To evaluate intervention delivery processes in order to assist in the interpretation of the trial results and to inform potential implementation of the PRIDE interventions on a wider scale

To estimate the costs and cost-effectiveness of implementing the PRIDE interventions

Methods are described according to SPIRIT guidelines [ 33 ]. Completed SPIRIT checklists for the two trials are provided as Additional files  1 and 2 .

Study setting

The two trials will be conducted in six Government-run secondary schools in New Delhi, India. The schools were purposively selected in consultation with the Department of Education, Government of New Delhi, to focus on relatively under-served, low-income communities. Of the six schools, three are boys’ schools, two are girls’ schools and one is co-educational. Each school contains grades 6–12, of which grades 9–12 will be the focus of this research. As of August 2018, there were 172 classes in grades 9–12 with a total student population of 8448 (ranging from 1050 to 1632 per school; mean = 1408; standard deviation (SD) = 225), including 4694 (56%) boys and 3754 (44%) girls.


Figures  1 and 2 summarize the participant timeline and flow for the embedded recruitment trial as per CONSORT guidelines for reporting stepped-wedge, cluster-randomized controlled trials [ 36 ]. Figure  3 presents the CONSORT diagram for the host trial [ 37 ].

figure 1

Illustration showing implementation of the control and intervention conditions in the embedded recruitment trial. The white boxes indicate the group of classes in the control condition and the colored boxes indicate the group of classes in the intervention condition. *0 = control condition; 1 = intervention condition

figure 2

CONSORT flowchart for the embedded recruitment trial. The white boxes indicate the group of classes in the control condition and the colored boxes indicate the group of classes in the intervention condition

figure 3

CONSORT flowchart for the host trial

Seventy classes will participate in the embedded recruitment trial. These classes will be selected at random using computer-generated random numbers, stratified by school and grade, drawing from a pool of 118 eligible classes (excluding 54 classes that had received sensitization during earlier pilot work in these schools). The participating 70 classes will be randomized to receive the control and intervention conditions across two sequences. A small block size of 2 will be used to allocate the 70 classes across the two sequences in order to ensure balance, as the number of classes within each grade from the individual schools is relatively small. In the rare instance that a selected class has been dissolved or merged with another class, the next class in the random list will be included to replace the unavailable class. Each sequence will be implemented over three consecutive 4-week intervals (excluding holidays and exam breaks). Thus, each class will switch over from the control to the intervention condition at 4-week intervals, over two steps (Fig.  1 ). Schedules for sensitization in the allocated classes will be shared with the schools in advance to ensure access.

Referrals to the host trial will be generated through a combination of self-referrals, teacher referrals, and referrals made by friends, siblings, and/or parents. These referrals will be drawn from the 70 classes sampled in the embedded recruitment trial, with additional participants recruited from the remaining 102 classes as needed. The precise schedule of recruitment activities in the latter classes will be calibrated according to referral patterns and caseload capacity for intervention providers in the various schools. When initiating a self-referral, students will have the option to either approach a counsellor directly or else post a completed referral form/written note in a secure drop-box. The school counsellor will also serve as a central point of contact for other potential referrers, and will offer referral forms on request. All referred adolescents will be followed up by a researcher and screened for eligibility to participate in the host trial (Table  1 ).

Consenting participants (see section on consent procedures below) will be enrolled by researchers and randomized to the intervention or the control arm after baseline outcome assessments are completed. Participants who are randomized to the intervention arm will be escorted by a researcher to meet the counsellor in an adjacent room/cubicle, ensuring efficient and discrete handover. The randomization list will be developed by an independent statistician (HW), applying stratification by school (and gender for the co-educational school) using randomly sized blocks of four or six. The randomization code will be concealed using sequentially numbered opaque sealed envelopes to maximize allocation concealment. Errors in randomization will be recorded and reported.

Sample size and power calculations

We based our power calculation on a within-period comparison [ 38 ] for a stepped-wedge design using Stata package “clustersampsi”. Based on pilot data, we anticipated referral rates of 5% and 15% on the control and intervention conditions, respectively, with an intra-cluster correlation coefficient (ICC) of 0.124. We assumed the same ICC for the between-time correlation given the short time period of follow-up. In practice, it may be smaller than 0.124 and both ICCs will be reported. Using these parameters, a sample size of 70 classes (average class size of 50 students) will have 92% power to detect a difference of 10 percentage points (treating the outcome as a binomial variable), at a significance level of 0.05.

Sample size estimations were produced for two co-primary outcomes: severity of adolescent-reported mental health symptoms measured by the Total Difficulties score on the Strengths and Difficulties Questionnaire (SDQ) and severity of idiographic problems measured by the Youth Top Problems (YTP; Table 2 ). We based the estimations on two data sources. First, we obtained uncontrolled effect sizes (ES = Difference in means/pooled SD) for both co-primary outcomes from a group of 52 adolescents who received the problem-solving intervention during pilot work in the six secondary schools in New Delhi. Among these students, all of whom met the same baseline eligibility criteria as intended for the current trial, the mean SDQ Total Difficulties scores changed from 23.4 (SD 3.4) at baseline to 16.1 (SD 5.9) at the end of the intervention (ES = 1.4). The mean YTP scores for the same group changed from 5.6 (SD 2.0) at baseline to 2.9 (SD 2.6) at the end of the intervention (ES = 0.9). Second, we obtained a paired effect size on the SDQ Total Difficulties score from another cohort of 47 adolescents participating in a later phase of piloting, including 29 students who received the problem-solving intervention and 18 waitlisted controls (ES = 1.0). YTP data were unavailable for this second cohort. Effect sizes in trials are often smaller than in pilots so we conservatively hypothesized that our intervention would be associated with an ES = 0.5 on both the co-primary outcomes with 90% power. We assumed a 1:1 allocation ratio of individual participants within each of the six schools, loss to follow-up of 15% over 6 weeks (based on piloting), and a Bonferroni correction to adjust for multiple primary outcomes. Based on these assumptions, we determined that N  = 240 participants would be required. This sample size also provides 80% power to detect an ES of 0.44.


Intervention condition.

This will comprise a one-off 30-min classroom session that is intended to improve understanding about signs and symptoms of mental health problems, raise awareness about the school counselling service, and generate demand for the service. The session will be delivered for individual classes (approximately 50 students per class) by a counsellor (drawn from the same group responsible for the problem-solving intervention in the host trial) with assistance from a researcher who will have additional responsibilities for processing referrals and conducting eligibility assessments. The classroom session will start with a short animated video ( https://drive.google.com/file/d/1Y2NoMYf-NTjuNekYgxWZf7nNZIg88E98/view?usp=drivesdk ) which provides age-appropriate information about types, causes, impacts and ways of coping with common mental health problems. The video will be followed by a guided group discussion, structured around a standardized script that builds on the topics covered in the video. In case of technical difficulties that may prevent the video from being shown, the counsellor will use a flipchart based on printed images from the video. At the end of the session, students will be handed a self-referral form which includes normalizing information and question-based prompts to assist with self-identification of mental health problems. Interested students can approach the facilitators immediately after the session with self-referral forms, or else deposit the forms discreetly in a secure drop-box located outside or near to the counsellor’s usual room.

The counsellors and researchers delivering the classroom sensitization sessions will be provided with a structured manual and complete a one-day, office-based training. Training will be conducted by master’s level psychologists (who will also serve as supervisors) and comprise lectures, demonstrations, and role-plays. The training will be followed by a period of supervised field practice, when the counsellors and researchers will be required to complete at least two classroom sessions independently under direct observation from supervisors. Fidelity of intervention delivery will be assessed on a checklist of observable procedures which have been distilled from the intervention manual. Each procedure will be rated on a three-point Likert scale (not completed, partially completed, fully completed). A ‘refresher’ training session will also be conducted before the trial begins.

Control condition

This will comprise whole-school sensitization activities. The supervisor will meet the principal of each school individually to inform them about planned counselling and research activities and to seek their cooperation for the same. This meeting will also provide structured information about common mental health problems faced by adolescents and address any concerns related to planned procedures and resource demands. Teachers will be invited to participate in separate group sensitization meetings (up to 30 teachers at a time). A standardized script will mirror the topics covered in the meetings with the school principals, but with additional emphasis placed on referral procedures for the host trial. Up to three meetings will be held in each school to maximize coverage of teaching staff. These meetings will be conducted by the same counsellor and researcher pairings responsible for delivering the classroom intervention. Posters will be placed in highly visible locations such as noticeboards or common corridors, in addition to signage on the drop-box, which will remind students (and teachers) of the counselling service.

Intervention arm

A problem-solving intervention will be delivered to individual students across four to five face-to-face sessions spread over 3 weeks. Each session will last for up to 30 min (aligned with the usual duration of school periods) and will be delivered in the local language (Hindi). The sessions will be conducted on school premises in private rooms or, where private rooms are not available, behind screens and curtains in a suitable location (e.g., the school library). Such contingencies to address space limitations were piloted in earlier work and deemed to be feasible and acceptable in the local context, enabling a temporary counselling space in which students would not be on direct view.

Session 1 will focus on fostering engagement, understanding the participant’s difficulties, and introducing the structure and process of the intervention. Over the next three sessions, the participant will be helped to learn and apply a structured problem-solving strategy involving three steps (following the acronym “POD”): (1) identify and prioritize distressing/impairing problems (“ P roblem identification”); (2) generate and select coping options for modifying the identified problem directly (problem-focused strategies) and/or the associated stress response (emotion-focused strategies) (“ O ption generation”); and (3) implement and evaluate the outcome of this strategy (“ D o it”). The intervention may be concluded after four sessions or else extended to a fifth session, depending on the adolescent’s preferences and logistical barriers to intervention completion such as exam breaks and holidays. The concluding session will focus on consolidating learning and generalizing problem-solving skills across different contexts. With permission, all sessions will be audio-recorded for office-based quality and fidelity assessments. Adolescents will be encouraged to practice problem-solving skills between the sessions, aided by a set of three “POD booklets” which explain problem solving using illustrated vignettes and suggest corresponding between-session practice exercises. The booklets (each corresponding to one of the steps of problem solving) will be distributed sequentially over the first three intervention sessions. In the concluding session, the adolescent will be additionally handed a full-color POD poster that summarizes the three steps of problem-solving.

Each school will have one or two counsellors, depending on demand. The counsellors will be Hindi-speaking college graduates aged 18 years or above, with no formal training or qualifications related to psychotherapy or mental health. They will be recruited through online job portals commonly used in the NGO/public sector in India. Selection will be based on reasoning capacity (assessed by written test) and interpersonal skills (assessed by structured role-plays and interview). Selected candidates will receive an intervention manual and complete one week of classroom-based training involving a combination of lectures, demonstrations, and role-plays. This will be followed by a minimum 6-week period of field training in which counsellors will carry out casework (with at least four cases) under the supervision of psychologists. Trainees’ performance will be evaluated using structured role-plays at the end of classroom-based training, as well as supervisors’ ratings of audio-recorded intervention sessions.

Counsellors will participate in weekly peer group supervision meetings, based on an approach tested in the PREMIUM trials, where it was found to be an acceptable, effective, and scalable supervision model for lay counsellors in low-resource settings [ 39 ]. Each 2-h meeting will be facilitated by one of the counsellors in rotation and overseen by a supervisor. Counsellors will review and discuss one or two audio-recorded sessions in each meeting. Audio-recordings will be rated by all group members using a therapy quality rating scale that incorporates elements from two established scales [ 40 , 41 ] and assesses skills specific to problem solving as well as non-specific therapeutic skills (e.g., empathic understanding). Recurrent skills deficits noted by supervisors will be addressed through supplementary training workshops held on a monthly basis. The supervision schedule will ensure a representative selection of audio-recorded sessions, with the intention that all counsellors should receive equal opportunities to discuss their cases. In addition, supervisors will undertake weekly telephone calls (lasting 20–30 min) with each counsellor in order to monitor the progress of their caseload, and identify and manage risks. The counsellors will be able to initiate ad hoc calls if urgent consultation is needed on any case.

Control arm

There are no mental health services in the participating schools. A standardized control arm was devised accordingly, keeping in mind the requirement to offer a pragmatic, resource-efficient mode of support with minimal risk of contamination between trial arms. In terms of contamination, a recent scoping review of complex intervention trials in mental health [ 42 ] found that the principal processes leading to contamination were the same clinicians treating participants across conditions and communication between clinicians/participants. Moreover, the review recommended that methods other than cluster randomization should be considered to minimize contamination, given the lack of evidence for a link between the level of randomization and intervention effect size.

Participants allocated to the control arm will therefore receive the same printed problem-solving materials used in the intervention arm but without any counsellor contact. Immediately following random allocation to this condition, a researcher (rather than a counsellor) will provide a set of POD booklets and explain their purpose and contents using a standardized script. Students will be encouraged to read through the booklets in sequence and complete the specified practice exercises. No further guidance will be provided. In this way, all trial participants will receive the POD booklets, thereby eliminating the likeliest source of contamination. The counselling process itself is less likely to spill-over as this will be delivered in a one-to-one individual format, and our formative and pilot work showed that students emphasized confidentiality (mentioned earlier) such that disclosure of counselling experiences should be minimized.

Screening and outcome measures

The primary outcome (referral rate based on the proportion of referred adolescents as a function of the total sampling frame in each condition) will be collated from referral logs maintained by researchers in each school. Referral data will be aggregated over each 4-week calendar period. Students deemed ineligible for participation in the host trial will be allowed to re-refer themselves after a gap of 4 weeks, offering a suitable time period to re-assess mental health status in line with the host trial’s inclusion criterion about symptom chronicity (Table  1 ). Secondary outcomes pertaining to the eligibility and clinical characteristics of students referred to the host trial will be derived from screening data on the SDQ (see below).

All screening and outcome assessments will be undertaken using standardized self-report measures that have been translated into Hindi. Clinical eligibility criteria (i.e., severity, chronicity, and impacts of mental health symptoms) will be assessed using the adolescent-reported form of the SDQ (including the Impact Supplement). The same screening data will also serve as the baseline SDQ/Impact Supplement outcomes for eligible participants who are subsequently enrolled in the trial; baseline assessments for other outcome measures will be completed as soon as possible after completing consent procedures (ideally within 2 working days). The adolescent-reported SDQ/Impact Supplement will be repeated at 6 and 12 weeks post-randomization, along with the parent-reported SDQ/Impact Supplement, and adolescent-reported Youth Top Problems (YTP) [ 43 ], Perceived Stress Scale-4 (PSS-4) [ 44 ] and Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) [ 45 ]. These measures are described in Table  2 . The SDQ will also serve as the basis for assessing remission at both end-points, defined as falling below cut-offs for eligibility on both the SDQ Total Difficulties score and Impact score.

Process measures

Process data on enrollment, randomization, and assessment procedures in both trials will be obtained from researcher-completed record forms. These will be collated to obtain assent/consent rates of adolescents and parents (and reasons for missing assent/consent); randomization rates (and reasons for randomization errors); completion rates of baseline and follow-up outcome assessments (and reasons for non-completion); and time lags between intended and completed assessments (and reasons for deviating from targets). In addition, motivations for help-seeking and expectancies for the school counselling program will be explored at the time of eligibility assessment through a brief qualitative interview with a sub-sample of referred students. Assent/consent to use the interview data in the research will be obtained as part of the consent process for the embedded recruitment trial.

Intervention processes will be assessed using additional data sources. In the embedded recruitment trial, counsellor-completed record forms will provide data on key participation indicators, including attendance rates and duration for all teacher meetings and classroom sensitization sessions, in addition to the numbers of posters and drop-boxes installed in the schools.

In the intervention arm of the host trial, counsellor-completed session record forms will be used to obtain process data on duration, spacing, and frequency of attended sessions (and reasons for non-attendance); and intervention uptake and completion rates (and reasons for pre-intervention and mid-intervention drop-out). Participants’ adherence to intervention activities and potential engagement challenges will be assessed using checklists within the same record forms, indicating whether or not the student completed practice exercises at home; used the POD booklets at home; brought the POD booklets to the session; and demonstrated understanding of POD booklets and session content. Use of POD booklets will be assessed in each arm of the trial at 6- and 12-week follow-up using a brief adolescent-reported measure that asks about estimated frequency of home use and perceived helpfulness of POD booklets in the preceding 6 weeks. Service satisfaction data will also be obtained from participants in each trial arm at 12 weeks using an eight-item service satisfaction questionnaire [ 53 ]. Three supplementary questions will elicit open-ended written feedback on the most preferred aspects of the service, potential areas for improvement and recommended changes.

Intervention quality and fidelity will be assessed in both trials using independent ratings of audio-recorded sessions. For the classroom sensitization intervention, 20% of all recordings will be selected at random and rated by a psychologist who is not directly involved with supervision of the intervention providers. A similar approach will be taken with the problem-solving intervention, for which 10% of all audio-recorded sessions will be rated independently. Reliability of the independent raters will be established initially by comparison with intervention quality and fidelity ratings from supervisors (see above).

The researchers who co-facilitate the classroom sensitization sessions will also record referrals and conduct the host trial eligibility assessments. Blinding of the outcome assessors will therefore not be possible.

Baseline and outcome assessments will be conducted by separate teams of researchers. All trial investigators, apart from the data manager (BB), will be blind to allocation status until the trial arms are revealed in the presence of both the Trial Steering Committee (TSC) and Data Safety and Monitoring Committee (DSMC). However, unblinding of individual participants may be undertaken if requested by the DSMC (e.g., in case of a serious adverse event).

Data collection, management, and analysis

Data collection.

There will be a seamless flow of adolescents from the embedded recruitment trial to the host trial. The schedules for enrollment, interventions, and assessments are summarized in separate SPIRIT diagrams for the embedded recruitment trial (Fig.  4 ) and host trial (Fig.  5 ). A team of school-based researchers will process the referrals, undertake eligibility assessments for the host trial (within a target of ≤ 3 working days from the date of referral) and obtain adolescent assent/consent (within the same day if possible). A separate team of community-based researchers will visit parents/guardians (within a target of ≤ 2 working days after confirming an adolescent’s eligibility) to obtain consent and complete baseline outcome assessments (within the same day if possible). The school-based research team will complete baseline outcome assessments with adolescents once all consent procedures are completed (within a target of ≤ 2 working days). All assessment procedures should therefore be completed within 7 working days from the date of referral.

figure 4

SPIRIT figure for the embedded recruitment trial

figure 5

SPIRIT figure for the host trial

The community-based research team (blinded to allocation) will complete follow-up assessments at 6 and 12 weeks post-randomization. Assessments will take place at participants’ homes or other convenient locations, within a maximum period of 7 calendar days from the due date. Researchers will make up to four approaches for each scheduled contact.

Process data from researchers’ logs and counsellors’ session records will be captured on paper forms. All other measures, except for the YTP (which rates idiographic problems and does not readily lend itself to a digital format), will be administered via a tablet computer.

Data management

Data will be collected digitally using the customized STAR software program [ 54 ], and will be remotely uploaded as comma-separated values (CSV) files on a secured server. The date and time stamps for original data entry will be included, and an audit trail documenting any subsequent changes will be maintained. All paper-based data will be entered manually in SQL Epi-info forms and linked by participant ID with digitally collected data. Range and consistency checks will be performed at weekly intervals, with all inconsistencies and corrections logged to maintain an audit trail. All data will be anonymized and backed-up on external hard disks on a daily basis. All session audio-recordings will be linked with the participant ID and stored in a separate, secure, password-protected folder. A separate password-protected file linking names and participant IDs and the random allocation code will be maintained securely by the data manager and will not be accessed until the unblinding of the trial. All data will be shared in an encrypted form in password-protected files and through secure electronic transfer, when necessary.

Data analysis

Quantitative analysis will be conducted using STATA (version 15). A detailed analysis plan will be agreed with the DSMC before any analysis is undertaken. Findings will be reported as per CONSORT guidelines [ 37 ] for the host trial, and the CONSORT extension for reporting of stepped-wedge, cluster-randomized trials for the embedded recruitment trial [ 36 ].

The baseline characteristics of the participating 70 classes, including class size and gender composition, will be described and assessed for any systematic differences across the two sequences. The primary outcome will be analyzed using generalized estimating equations (GEE) with robust standard errors. GEE is a recommended method for analysis of stepped-wedge, cluster-randomized controlled trials, providing population-averaged effects of exposure across trial conditions [ 55 ]. GEE allows for longitudinal data analysis without resorting to fully specified random effect models and can be applied to both continuous and categorical outcomes [ 56 ]. It provides both parameter estimates and standard errors that are corrected for clustering of data and are consistent despite misspecifications in the correlation structure. For this trial, the clustering of data will be specified at the class level. Analysis of the secondary and exploratory outcomes will also be undertaken using the GEE method. Sensitivity analysis will be conducted using a ‘within-period comparison’ of data [ 38 ] from the second period only. No interim analyses will be undertaken.

The trial flowchart will include the number of students referred, screened, eligible, randomized, followed up at 6-week and 12-week endpoints and analyzed for the primary outcomes. The number refusing participation or excluded (with reasons), actively withdrawing, and passively lost to follow-up will be shown by arm. These will be summarized by means (standard deviation), medians (interquartile range), or numbers and proportions as appropriate to relevant subgroups (defined by age, gender, and baseline outcome score). For continuous outcomes, histograms within each arm will be plotted to assess normality and determine whether transformation is required.

The primary analyses will be on an intention-to-treat basis at the 6-week end-point, adjusted for baseline values of the outcome measure; school (as a fixed effect in the analysis) to allow for within-school clustering; counsellor variation (as a random effect); variables for which randomization did not achieve reasonable balance between the arms at baseline; and variables associated with missing outcome data [ 57 ]. Analyses of outcomes will be conducted using linear mixed-effects regression models for continuous outcomes with normally distributed errors (e.g., SDQ Total Difficulties score) and generalized (logistic) mixed-effects regression models for binary outcomes (e.g., remission rate). Intervention effects will be presented as adjusted mean differences and effect sizes (ES), defined as standardized mean differences. We will use 95% confidence intervals (CIs) for continuous outcomes, and adjusted odds ratios with 95% CIs for binary outcomes. Additionally, intervention effects for students who receive fewer sessions than prescribed will be estimated using the Complier Average Causal Effect structural equation model [ 58 ]. Repeated-measures analysis will be used to analyze data from the two end-points (6 and 12 weeks). Initial models will include an interaction effect between arm and time to allow for differential effects at these two end-points. This will be retained if there is evidence of effect modification by time. No interim analyses of outcomes will be undertaken.

We will explore potential moderators of intervention effects, with respect to a priori defined modifiers (chronicity of mental health difficulties, severity of mental health difficulties, YTP type, and SDQ caseness profile). We will fit relevant interaction terms and test for heterogeneity of intervention effects in regression models. A mediation analysis will be conducted to examine whether the theoretically driven a priori factor (perceived stress at 6 weeks) mediates the effects of the intervention on mental health symptoms and idiographic problems at 12 weeks.

Process evaluation

We will undertake descriptive statistical analysis of quantitative process data to explore the differential implementation of intervention procedures. In addition, thematic analysis will be used to code and organize qualitative interview data on service expectancies (assessed prior to enrolment in the host trial) and qualitative written feedback on service satisfaction (assessed at 12-week follow-up in the host trial). Findings from the various data sources will be triangulated and used to develop explanatory hypotheses about potential differences in intervention delivery and participation across schools, subgroups of participants, and providers. Process evaluation findings will be used to facilitate interpretation of the main trial results. The trial statisticians may conduct further analyses to test hypotheses generated from integration of the process evaluation and trial outcome data; these will necessarily be post hoc and identified as such in any subsequent publications.

Cost-effectiveness analysis

An economic evaluation will be conducted to estimate the costs and incremental cost-effectiveness of the problem-solving intervention. A combination of top-down and ingredients-based costing approaches will be used to generate cost estimates for the whole package, and for each package component (e.g., counselling sessions and POD booklets), in the intervention and control arms. All costing will be estimated from the providers’ perspective (the schools and the implementing partner Sangath); financial and economic costs will be calculated for all inputs (e.g., materials, training, supervision, staff time, overheads). The cost analysis will assess the costs of setting up and running the interventions; the distribution of costs across different forms of inputs; the unit cost per student/adolescent reached; the cost per additional case remitted; the cost of delivering all activities in intervention schools; and the cost per unit of measure for selected primary and secondary outcomes. We will estimate the incremental cost-effectiveness of the intervention relative to the control condition (enhanced usual care). The cost-effectiveness measure proposed here will be compared to similar school programs in the region and it will inform program replication, scalability, and financial sustainability.

Results will be plotted on a cost-effectiveness plane and presented as cost-effectiveness acceptability curves to show the probability of the intervention being cost-effective at a range of willingness-to-pay threshold levels. A sensitivity analysis will be conducted to take account of uncertainty and imprecision in the measurements.

Trial governance

Monitoring and governance for both trials will be provided by a Trial Management Group (TMG; comprising senior investigators and project staff involved in day-to-day coordination of research activities), TSC (comprising senior investigators and independent subject experts), and DSMC (a fully independent group with relevant clinical and trials expertise). The TMG and TSC will review trial process indicators (e.g., rates of screening, eligibility, consent, outcome assessments, adverse events) fortnightly and quarterly, respectively. The independent DSMC will meet at the outset of the two linked trials and again at the time of unblinding the trial results, as well as receiving reports of emergent serious adverse events (as per criteria below). Any trial protocol amendments will be agreed and formulated in conjunction with the TSC and DSMC and submitted to relevant Institutional Review Boards for approval.

Research ethics

Approvals have been obtained from the Institutional Review Boards of Sangath, Harvard Medical School, the London School of Hygiene and Tropical Medicine, and Indian Council of Medical Research. Harvard Medical School is the trial sponsor while Sangath is the implementing agency in India.

A two-stage consent process will be used across both trials. To begin, a school-based researcher will provide each referred student with structured verbal and written information about the use of their screening data for research purposes (as part of the embedded recruitment trial), irrespective of their eligibility to take part in the host trial. Students will be able to opt-out from providing any self-reported data for the embedded recruitment trial. Students meeting eligibility criteria for the host trial will be provided with additional structured verbal information and a printed participant information sheet. Assent will be sought for adolescents aged below 18 years and consent will be sought for adolescents who are 18 years or older. For assenting participants aged under 18 years, consent will also be sought from a parent/guardian for participation of the index adolescent and for their own participation in outcome assessments. Consenting adolescents aged 18 years or older will be able to take part without permission from their parent/guardian. We will seek their permission before approaching a parent/guardian about participating in assessments. When approaching the family member of an index adolescent, telephone contact will be initiated by a community-based researcher in the first instance, after which a meeting will be arranged at their home or another convenient location, if agreed.

Serious adverse events

Serious adverse events (SAEs) include death, life-threatening events, clinical deterioration requiring hospitalization or other specialist treatment, victimization, sexual abuse, and chronic absenteeism and/or drop-out from school. Immediate safeguarding actions will prioritize the safety of participants. This may involve suicide risk assessment, informing stakeholders, facilitating treatment with specialists, and statutory reporting in line with relevant legislation, such as the Protection of Children from Sexual Offences Act 2012 and the Juvenile Justice (Care and Protection) Act 2000 (last amended in 2015).

Each potential SAE will also be assessed for causality by two clinically qualified co-investigators and classified as unrelated, unlikely, possible, probable, or definitely related to trial participation. In the event that consensus is not reached, a third clinical psychologist (independent of the trial) will review the SAE report. Where causality is deemed to be anything other than unrelated to trial participation, the DSMC will advise on further actions such as withdrawal of individual participants, modifications to the trial protocol, continuing without modifications, or suspending/terminating the trial.

This paper describes an integrated protocol that will evaluate the demand for a school counselling program delivering a low-intensity psychological intervention, and the effectiveness of that intervention for school-going adolescents with elevated mental health presentations in New Delhi, India. The interventions used in the host trial and embedded recruitment trial will be provided by lay counsellors, working under the supervision of psychologists, in Government-run secondary schools catering to adolescents from lower socio-economic groups of the city. Concurrent process evaluation and cost-effectiveness analysis will complement the effectiveness findings, generating important evidence relevant to the scaling up of the interventions. To the best of our knowledge, these two trials have no comparable precedent from any low-resource context, and our findings have the potential to inform the design of school-based interventions to address adolescent mental health problems on a large scale in India and other global settings.

An individually randomized design was chosen for the host trial due to the relatively small number of available schools, which ruled out an alternative cluster-randomized design. The inherent risk of contamination associated with individual randomization was minimized by the inclusion of an enhanced usual care control arm, in which participants received the same printed materials as provided in the intervention arm. The augmentation of face-to-face counselling in the intervention arm was not expected to pose a significant risk of spill-over due to the reluctance of participants to share confidential counselling experiences with peers. Moreover, enhanced usual care was designed in such a way that the same delivery agents would not be involved in treating participants across conditions, ruling out another commonly cited source of contamination [ 42 ].

The use of a stepped-wedge cluster randomized design for the embedded recruitment trial was also influenced by pragmatic considerations. Formative and pilot work showed that classroom-based sensitization activities had the potential to increase the volume of referrals for school-based counselling. A stepped-wedge design—in which classes formed natural clusters in each school—offered the potential to stagger the roll-out of classroom sessions so that school-based counsellors could accommodate the anticipated flow of referrals within their limited caseload capacity.

Despite the use of contextually adapted sensitization activities, some potentially eligible students (and/or their caregivers) may be unwilling to participate. Reasons for non-participation will be systematically recorded and examined in the embedded process evaluation. We will also seek to address the concerns of referred adolescents who are not eligible for inclusion in the host trial despite a felt need for counselling. In anticipation, we have designed hand-outs with advice on self-management of common problems (such as academic stress). These hand-outs will be distributed to relevant students by the researchers conducting the baseline screening assessments. Another recruitment challenge relates to the academic calendar in the participating schools, which includes frequent breaks for exams, festivals, and other holidays. These scheduling disruptions may require temporary halting of recruitment (for example, so that students are not recruited immediately prior to a long break, as they would not be able to receive the intervention without a delay).

In addition to the publication of our findings in separate papers for each trial, we will share trial outcomes and implications with the participants and other stakeholder groups, including school principals and the local Department of Education in New Delhi. If effective, we will use the process and economic data to model the costs for scaling up the interventions across the school system in New Delhi. This may involve the deployment of counsellors by the state government under the Educational and Vocational Guidance Scheme (EVGC), due for implementation in some sectors of New Delhi starting from the 2018–2019 academic year.

Trial status

Both trials are registered with ClinicalTrials.gov (host trial, NCT03630471, https://clinicaltrials.gov/ct2/show/NCT03630471 ; embedded recruitment trial, NCT03633916, https://clinicaltrials.gov/ct2/show/NCT03633916 ). Recruitment for both trials was initiated on 20 August 2018. We expect to conclude participant recruitment by February 2019 and complete follow-up assessments by June 2019.

Availability of data and materials

Data from pilot studies used for arriving at sample size and power calculations can be made available by the corresponding author upon reasonable request.


Confidence interval

Data Safety and Monitoring Committee

Effect size

  • Low- and middle-income countries

Perceived Stress Scale-4

Serious adverse event

Standard deviation

Strengths and Difficulties Questionnaire

Short Warwick-Edinburgh Mental Wellbeing Scale

Trial Steering Committee

Youth Top Problems

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We gratefully acknowledge the contributions made by Aoife Doyle in preparing the statistical analysis plan for the host trial and by Bhagwant Chilhate in data collection and management of the host trial.

This study was supported by a Principal Research Fellowship awarded to Vikram Patel by the Wellcome Trust (grant number 106919/A/15/Z). The funding agency has no role in the design of the study and in data collection or the writing of the manuscript.

Author information

Rachana Parikh and Daniel Michelson are joint first authors

Authors and Affiliations

Sangath, C-1/52, 1st Floor, Safdarjung Development Area, New Delhi, Delhi, 110016, India

Rachana Parikh, Kanika Malik, Sachin Shinde, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur & Vikram Patel

Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, van der Boechorstraat 1, 1081 BT, Amsterdam, The Netherlands

Rachana Parikh

School of Psychology, University of Sussex, Falmer, Brighton, BN1 9RH, UK

Daniel Michelson

MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK

Helen A. Weiss

Amsterdam UMC, Amsterdam Public Health research institute, Vrije Universitiet, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands

Adriaan Hoogendoorn & Jeroen Ruwaard

GGZ inGeest Specialized Mental Health Care, Oldenaller 1, 1081 HL, Amsterdam, The Netherlands

Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore, Karnataka, 560029, India

Paulomi Sudhir

Division of Psychiatry, Faculty of Brain Sciences, University College London, Maple House, 149 Tottenham Court Rd, London, W1T 7NF, UK

Michael King

Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, van der Boechorstraat 1, 1081, BT, Amsterdam, The Netherlands

Pim Cuijpers

Department of Psychology, University of California, Los Angeles, 3227 Franz Hall, Los Angeles, CA, 90095-1563, USA

Bruce F. Chorpita

University Department of Psychiatry, Warneford Hospital, Oxford, Oxford, OX3 7JX, UK

Christopher G. Fairburn

Department of Global Health and Social Medicine, Harvard Medical School, 641, Huntington Avenue, Boston, MA, 02115, USA

Vikram Patel

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VP led the conception of the trials with contributions from all other authors. DM, RP, SS, and VP led on trial design and developed the initial draft of the manuscript with contributions from HW, AH, and JR on statistical considerations; KM, RS (R. Sharma), SM, and MK (M. Krishna) on the description of trial interventions; and BB and RS (R. Sahu) on data collection and management. MK (M. King), CF, BC, PC, and PS reviewed the manuscript at different stages and provided critical revisions. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Vikram Patel .

Ethics declarations

Ethics approval and consent to participate.

Written informed consent will be obtained from all participants in both the trials. For adolescents younger than 18 years of age (minors), informed consent will be obtained from parents or guardians of the adolescents. The study procedures were approved by the Institutional Review Boards of the Harvard Faculty of Medicine (reference IRB17–0379), Sangath (references VP_2018_41 and RP_2018_47) and London School of Hygiene and Tropical Medicine (LSHTM Ethics reference 15907). Additional approval from the Indian Council of Medical Research (HMSC/1/2016/SBR) and the Department of Education, Government of India (DE40 [20]/EVGB/2017/711–717) were also obtained before the commencement of the trials.

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Consent for publication of anonymized data will be obtained from trial participants.

Competing interests

The authors declare that they have no competing interests.

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SPIRIT checklist for embedded recruitment trial. (DOC 122 kb)

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SPIRIT checklist for host trial. (DOC 122 kb)

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Parikh, R., Michelson, D., Malik, K. et al. The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial. Trials 20 , 568 (2019). https://doi.org/10.1186/s13063-019-3573-3

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DOI : https://doi.org/10.1186/s13063-019-3573-3

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  18. The effectiveness of problem solving therapy for stroke patients: study

    The effectiveness of problem solving therapy for stroke patients: study protocol for a pragmatic randomized controlled trial. ... The primary aim of this study is to investigate if Problem Solving Therapy is an effective group intervention for improving coping style and health-related quality of life in stroke patients. The secondary aim is to ...

  19. Comparative effectiveness of family problem-solving therapy (F-PST) for

    Comparative effectiveness of family problem-solving therapy (F-PST) for adolescents after traumatic brain injury: Protocol for a randomized, multicenter, clinical trial Contemp Clin Trials Commun. 2018 Apr 5;10:111-120. doi: 10.1016/j.conctc.2018.04.001. eCollection 2018 Jun. Authors

  20. Problem solving therapy (PST) tailored for intimate partner violence

    Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial - PMC Journal List Trials v.21; 2020 PMC7268746 As a library, NLM provides access to scientific literature.

  21. The BEACON study: protocol for a cohort study as part of an evaluation

    Background and rationale {6a} In a linked separate paper, we have described the study protocol for a cluster randomised controlled trial (cRCT) to test the effectiveness of a new service that delivers blended problem-solving therapy (PST) compared with usual care (UC) in men aged 18 years or older who present to emergency departments (EDs) in Ontario with intentional self-harm.

  22. The effectiveness of a low-intensity problem-solving intervention for

    Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an ...

  23. PDF Cognitive Behavioral Therapy for Suicide Prevention

    Cognitive Therapy for Suicide Prevention Initial Phase Informed Consent Motivational Enhancement Suicide Risk Assessment and Narrative Timeline Interview Safety Planning Intervention (Stanley & Brown, 2012) Reasons for Living & Dying and Hope Kit Treatment Goals and Case Conceptualization Middle Phase Cognitive & Behavioral Strategies