Pilot Feasibility Study of Psychosocial Support to Improve Well-being of Adults in Humanitarian Crises in Nepal

Study Overview
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Brief Summary
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This is a pilot feasibility 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 feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.

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. In this project Group PM+ will be piloted in a district in Nepal, which was affected by the 2015 earthquakes in Nepal. The current pilot study will evaluate the acceptability and feasibility of Group PM+ in Nepal to informant a subsequent pragmatic cluster randomized controlled trial. This exploratory cluster randomized controlled trial (cluster randomized controlled trial) will be 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. This research strategy is informed by the United Kingdom Medical Research Council framework for the development of complex interventions, which recognizes iterations of: a) Intervention Development; b) Feasibility and Piloting; c) Evaluation; and d) Implementation. This framework recommends to first conduct feasibility and randomized pilot studies before conducting large scale trials. In this way possible problems of acceptability, compliance, delivery of the intervention, recruitment and retention can be detected before the large definitive scale trail is conducted.

Official Title
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Pilot Feasibility Study of 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

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 >2 on General Health Questionnaire (dichotomous item scoring method) 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: Group problem management plus<br>* Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support<br>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 |
| --- | --- | --- |
| Depression - Patient Health Questionnaire | 9-item measure of depression symptoms, culturally and clinically validated in Nepal | 1 week post-intervention | 

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 | 1 week post-intervention | 
| General psychological distress - General Health Questionnaire | 12-item measure of general psychological distress, previously validated for use in Nepal | 1 week post-intervention | 
| Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist | 8-tem measure of post-traumatic stress symptoms validated for use in Nepal | 1 week post-intervention | 
| Personalized Measure of Distress - Psychological Outcome Profiles | 3-item measure of personalized distress and problems, 4-items post-treatment | 1 week post-intervention | 
| Culture-specific general psychological distress - Nepali Psychosocial and Mental Health Problems | 5-item measure of somatic symptoms of psychosocial and mental health problems validated in Nepal | 1 week post-intervention | 
| Reducing Tension Checklist for Problem Management Plus Skills | 12-item measure of behavioral and psychosocial skills related to coping mechanisms | 1 week post-intervention |