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

Not Applicable

Completed

• Conditions: Depression; Posttraumatic Stress Disorder; Psychological Distress
• Interventions: Behavioral: Group problem management plus; Behavioral: Enhanced treatment as usual

• Registration Number: NCT03747055
• Lead Sponsor: George Washington University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-17
• Study First Posted: 2018-11-20
• Study Start: 2018-11-25
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 611

Inclusion Criteria

1. score YES to heart-mind problems on heart-mind screener
2. score >16 on World Health Organization Disability Assessment Scale

Exclusion Criteria

1. Presence of a severe mental disorder (e.g., psychosis)
2. Alcohol use disorder (score >16 on the alcohol use disorders identification test (AUDIT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group problem management plus	Group problem management plus	Five sessions of group low intensity psychological intervention
Enhanced treatment as usual	Enhanced treatment as usual	Referral to primary health care workers trained in mental health Gap Action Programme.

Primary Outcome Measures

Name	Time	Method
General psychological distress - General Health Questionnaire	20-weeks after baseline	12-item measure of general psychological distress, validated in Nepal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Transcultural Psychosocial Organization (TPO) Nepal; 🇳🇵 Biratnagar, Morang, Nepal