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Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises (GroupPM+)

Primary Purpose

Depression, Posttraumatic Stress Disorder, Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Group problem management plus
Enhanced treatment as usual
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Nepal, Psychological treatment, Task shifting, Humanitarian crisis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Transcultural Psychosocial Organization (TPO) Nepal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group problem management plus

Enhanced treatment as usual

Arm Description

Five sessions of group low intensity psychological intervention

Referral to primary health care workers trained in mental health Gap Action Programme.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Daily functioning - World Health Organization Disability Assessment Scale
12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal
Depression - Patient Health Questionnaire
9-item measure of depression symptoms, culturally and clinically validated in Nepal
Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist
8-tem measure of post-traumatic stress symptoms validated for use in Nepal
Cultural idiom of psychological distress - Heart-Mind Screener
2-item locally develop psychological distress screener
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
Somatic symptom burden - Somatic Symptom Scale
8-item brief measure of somatic symptom burden

Full Information

First Posted
October 31, 2018
Last Updated
October 12, 2020
Sponsor
George Washington University
Collaborators
World Health Organization, Transcultural Psychosocial Organization Nepal, Duke University, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03747055
Brief Title
Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises
Acronym
GroupPM+
Official Title
Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
World Health Organization, Transcultural Psychosocial Organization Nepal, Duke University, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Posttraumatic Stress Disorder, Psychological Distress
Keywords
Nepal, Psychological treatment, Task shifting, Humanitarian crisis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
611 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group problem management plus
Arm Type
Experimental
Arm Description
Five sessions of group low intensity psychological intervention
Arm Title
Enhanced treatment as usual
Arm Type
Active Comparator
Arm Description
Referral to primary health care workers trained in mental health Gap Action Programme.
Intervention Type
Behavioral
Intervention Name(s)
Group problem management plus
Intervention Description
Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support
Intervention Type
Behavioral
Intervention Name(s)
Enhanced treatment as usual
Other Intervention Name(s)
mental health Gap Action Program-Implementation Guide
Intervention Description
Referral to primary care workers trained in mental health Gap Action Program Implementation Guide
Primary Outcome Measure Information:
Title
General psychological distress - General Health Questionnaire
Description
12-item measure of general psychological distress, validated in Nepal
Time Frame
20-weeks after baseline
Secondary Outcome Measure Information:
Title
Daily functioning - World Health Organization Disability Assessment Scale
Description
12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal
Time Frame
20-weeks after baseline
Title
Depression - Patient Health Questionnaire
Description
9-item measure of depression symptoms, culturally and clinically validated in Nepal
Time Frame
20-weeks after baseline
Title
Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist
Description
8-tem measure of post-traumatic stress symptoms validated for use in Nepal
Time Frame
20-weeks after baseline
Title
Cultural idiom of psychological distress - Heart-Mind Screener
Description
2-item locally develop psychological distress screener
Time Frame
20-weeks after baseline
Title
Perceptions of support from family, friends, and others - Multidimensional Scale of Perceived Social Support
Description
12-item assessment of perceptions of support from 3 sources: Family, Friends, and a Significant Other
Time Frame
20-weeks after baseline
Title
Somatic symptom burden - Somatic Symptom Scale
Description
8-item brief measure of somatic symptom burden
Time Frame
20-weeks after baseline
Other Pre-specified Outcome Measures:
Title
Reducing Tension Checklist for Problem Management Plus Skills
Description
10-item measure of behavioral and psychosocial skills related to coping mechanisms
Time Frame
20-weeks after baseline

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-reported gender
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark van Ommeren, PhD
Organizational Affiliation
World Health Organization
Official's Role
Study Director
Facility Information:
Facility Name
Transcultural Psychosocial Organization (TPO) Nepal
City
Biratnagar
State/Province
Morang
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This will be shared for full trial.
Citations:
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Citation
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Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises

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