Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises

Study Overview
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Brief Summary
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This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).

Detailed Description
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Counselling programmes used in many humanitarian settings are often non- specific with unknown efficacy and safety. Only a few interventions in humanitarian crises have been rigorously tested, and most studied interventions focused on posttraumatic stress disorder. Beyond posttraumatic stress disorder, individuals may have a range of problems including depression, anxiety, and not being able to do daily tasks necessary for survival and recovery. However, interventions are often limited since they tend to target only a single outcome, are usually of longer duration (8-16 sessions) or require professionals. In low resourced settings interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. World Health Organization aims to develop a range of low-intensity scale-able psychological interventions that address these issues, as part of its mental health Gap Action Program. As a first step a simplified psychological intervention Problem Management Plus (PM+) has been developed. It has 4 core features that make the intervention suitable for low resourced setting exposed to adversities. First, it is brief intervention (5-sessions), delivered individually or in groups; second, it can be delivered by paraprofessionals (high school graduates with no mental health experience), using the principle of task shifting/ task sharing; third, it is designed as a trans- diagnostic intervention, addressing a range of client identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; fourth, it is designed for people in low-income country communities affected by any kind of adversity (e.g. violence, disasters), not just focusing on a single kind of adversity. Recent PM+ trails in Pakistan and Kenya have indicated PM+ to be effective in diminishing depression and anxiety and improving people's functioning and self- selected, culturally relevant outcomes. Group PM+ has been piloted in a district in Nepal, which was affected by the 2015 earthquakes. The pilot was conducted to gather information about the feasibility, safety and delivery of the intervention in the Nepali community settings; and to identify issues around training, supervision and outcomes measures. The pilot trial was successful in terms of acceptability and feasibility and detecting possible problems of compliance, delivery of the intervention, recruitment and retention. The current definitive study will evaluate the effectiveness of Group PM+ in Nepal through a pragmatic cluster randomized controlled trial.

Official Title
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Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal

Conditions
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Depression, Posttraumatic Stress Disorder, Psychological Distress

Intervention / Treatment
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* Behavioral: Group problem management plus
* Behavioral: Enhanced treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: score YES to heart-mind problems on heart-mind screener score >16 on World Health Organization Disability Assessment Scale Exclusion Criteria: Presence of a severe mental disorder (e.g., psychosis) Alcohol use disorder (score >16 on the alcohol use disorders identification test (AUDIT)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group problem management plus<br>Five sessions of group low intensity psychological intervention | Behavioral: Group problem management plus<br>* Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support<br>|
| Active Comparator: Enhanced treatment as usual<br>Referral to primary health care workers trained in mental health Gap Action Programme. | Behavioral: Enhanced treatment as usual<br>* Referral to primary care workers trained in mental health Gap Action Program Implementation Guide<br>* Other names: mental health Gap Action Program-Implementation Guide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General psychological distress - General Health Questionnaire | 12-item measure of general psychological distress, validated in Nepal | 20-weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily functioning - World Health Organization Disability Assessment Scale | 12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal | 20-weeks after baseline | 
| Depression - Patient Health Questionnaire | 9-item measure of depression symptoms, culturally and clinically validated in Nepal | 20-weeks after baseline | 
| Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist | 8-tem measure of post-traumatic stress symptoms validated for use in Nepal | 20-weeks after baseline | 
| Cultural idiom of psychological distress - Heart-Mind Screener | 2-item locally develop psychological distress screener | 20-weeks after baseline | 
| Perceptions of support from family, friends, and others - Multidimensional Scale of Perceived Social Support | 12-item assessment of perceptions of support from 3 sources: Family, Friends, and a Significant Other | 20-weeks after baseline | 
| Somatic symptom burden - Somatic Symptom Scale | 8-item brief measure of somatic symptom burden | 20-weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nepal, Psychological treatment, Task shifting, Humanitarian crisis