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Completed

NCT Number: NCT03747055

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

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+).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Transcultural Psychosocial Organization (TPO) Nepal

Biratnagar, Morang, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Group problem management plus

Behavioral

Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support

Enhanced Treatment as Usual

Behavioral

Referral to primary care workers trained in mental health Gap Action Program Implementation Guide

Other names: mental health Gap Action Program-Implementation Guide

Primary outcomes

  1. General psychological distress - General Health Questionnaire

    Time frame: 20-weeks after baseline

    12-item measure of general psychological distress, validated in Nepal

Secondary outcomes

  1. Daily functioning - World Health Organization Disability Assessment Scale

    Time frame: 20-weeks after baseline

    12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal

  2. Depression - Patient Health Questionnaire

    Time frame: 20-weeks after baseline

    9-item measure of depression symptoms, culturally and clinically validated in Nepal

  3. Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist

    Time frame: 20-weeks after baseline

    8-tem measure of post-traumatic stress symptoms validated for use in Nepal

  4. Cultural idiom of psychological distress - Heart-Mind Screener

    Time frame: 20-weeks after baseline

    2-item locally develop psychological distress screener

  5. Perceptions of support from family, friends, and others - Multidimensional Scale of Perceived Social Support

    Time frame: 20-weeks after baseline

    12-item assessment of perceptions of support from 3 sources: Family, Friends, and a Significant Other

  6. Somatic symptom burden - Somatic Symptom Scale

    Time frame: 20-weeks after baseline

    8-item brief measure of somatic symptom burden

Other outcomes

  1. Reducing Tension Checklist for Problem Management Plus Skills

    Time frame: 20-weeks after baseline

    10-item measure of behavioral and psychosocial skills related to coping mechanisms

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Duke University
  • King's College London
  • Transcultural Psychosocial Organization Nepal
  • World Health Organization

Registry information

Official study title

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

Acronym: GroupPM+

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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