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
About this trial
This is an interventional treatment trial for Depression focused on measuring Nepal, Psychological treatment, Task shifting, Humanitarian crisis
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)
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
NCT ID
NCT03747055
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
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:
PubMed Identifier
28809935
Citation
Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.
Results Reference
background
PubMed Identifier
28689511
Citation
Khan MN, Hamdani SU, Chiumento A, Dawson K, Bryant RA, Sijbrandij M, Nazir H, Akhtar P, Masood A, Wang D, Wang E, Uddin I, van Ommeren M, Rahman A. Evaluating feasibility and acceptability of a group WHO trans-diagnostic intervention for women with common mental disorders in rural Pakistan: a cluster randomised controlled feasibility trial. Epidemiol Psychiatr Sci. 2019 Feb;28(1):77-87. doi: 10.1017/S2045796017000336. Epub 2017 Jul 10. Erratum In: Epidemiol Psychiatr Sci. 2019 Aug;28(4):466.
Results Reference
background
PubMed Identifier
28603552
Citation
Hamdani SU, Ahmed Z, Sijbrandij M, Nazir H, Masood A, Akhtar P, Amin H, Bryant RA, Dawson K, van Ommeren M, Rahman A, Minhas FA. Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial. Int J Ment Health Syst. 2017 Jun 8;11:40. doi: 10.1186/s13033-017-0147-1. eCollection 2017. Erratum In: Int J Ment Health Syst. 2018 Sep 27;12:53.
Results Reference
background
PubMed Identifier
28441974
Citation
Chiumento A, Hamdani SU, Khan MN, Dawson K, Bryant RA, Sijbrandij M, Nazir H, Akhtar P, Masood A, Wang D, van Ommeren M, Rahman A. Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial. Trials. 2017 Apr 26;18(1):190. doi: 10.1186/s13063-017-1905-8.
Results Reference
background
PubMed Identifier
27863515
Citation
Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. doi: 10.1186/s12888-016-1117-x.
Results Reference
background
PubMed Identifier
27265713
Citation
Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.
Results Reference
background
PubMed Identifier
27252778
Citation
Sijbrandij M, Bryant RA, Schafer A, Dawson KS, Anjuri D, Ndogoni L, Ulate J, Hamdani SU, van Ommeren M. Problem Management Plus (PM+) in the treatment of common mental disorders in women affected by gender-based violence and urban adversity in Kenya; study protocol for a randomized controlled trial. Int J Ment Health Syst. 2016 May 31;10:44. doi: 10.1186/s13033-016-0075-5. eCollection 2016. Erratum In: Int J Ment Health Syst. 2018 Oct 12;12:55.
Results Reference
background
PubMed Identifier
26428314
Citation
Sijbrandij M, Farooq S, Bryant RA, Dawson K, Hamdani SU, Chiumento A, Minhas F, Saeed K, Rahman A, van Ommeren M. Problem Management Plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT). BMC Psychiatry. 2015 Oct 1;15:232. doi: 10.1186/s12888-015-0602-y. Erratum In: BMC Psychiatry. 2018 Oct 15;18(1):331.
Results Reference
background
PubMed Identifier
26407793
Citation
Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
Results Reference
background
PubMed Identifier
34138875
Citation
Jordans MJD, Kohrt BA, Sangraula M, Turner EL, Wang X, Shrestha P, Ghimire R, Van't Hof E, Bryant RA, Dawson KS, Marahatta K, Luitel NP, van Ommeren M. Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial. PLoS Med. 2021 Jun 17;18(6):e1003621. doi: 10.1371/journal.pmed.1003621. eCollection 2021 Jun.
Results Reference
derived
PubMed Identifier
32307009
Citation
Van't Hof E, Sangraula M, Luitel NP, Turner EL, Marahatta K, van Ommeren M, Shrestha P, Bryant R, Kohrt BA, Jordans MJD. Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises in Nepal: study protocol for a cluster randomized controlled trial. Trials. 2020 Apr 19;21(1):343. doi: 10.1186/s13063-020-04263-9.
Results Reference
derived
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Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises
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