NCT03747055

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+).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
611

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

October 31, 2018

Last Update Submit

October 12, 2020

Conditions

DepressionPosttraumatic Stress DisorderPsychological Distress

Keywords

NepalPsychological treatmentTask shiftingHumanitarian crisis

Outcome Measures

Primary Outcomes (1)

  • General psychological distress - General Health Questionnaire

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

    20-weeks after baseline

Secondary Outcomes (6)

  • Daily functioning - World Health Organization Disability Assessment Scale

    20-weeks after baseline

  • Depression - Patient Health Questionnaire

    20-weeks after baseline

  • Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist

    20-weeks after baseline

  • Cultural idiom of psychological distress - Heart-Mind Screener

    20-weeks after baseline

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

    20-weeks after baseline

  • +1 more secondary outcomes

Other Outcomes (1)

  • Reducing Tension Checklist for Problem Management Plus Skills

    20-weeks after baseline

Study Arms (2)

Group problem management plus

EXPERIMENTAL

Five sessions of group low intensity psychological intervention

Behavioral: Group problem management plus

Enhanced treatment as usual

ACTIVE COMPARATOR

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

Behavioral: Enhanced treatment as usual

Interventions

Group problem management plusBEHAVIORAL

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

Group problem management plus
Enhanced treatment as usualBEHAVIORAL

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

Also known as: mental health Gap Action Program-Implementation Guide
Enhanced treatment as usual

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-reported gender
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • score YES to heart-mind problems on heart-mind screener
  • score \>16 on World Health Organization Disability Assessment Scale

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transcultural Psychosocial Organization (TPO) Nepal

Biratnagar, Morang, Nepal

Location

Related Publications (11)

  • 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.

    PMID: 28809935BACKGROUND

  • 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.

    PMID: 28689511BACKGROUND

  • 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.

    PMID: 28603552BACKGROUND

  • 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.

    PMID: 28441974BACKGROUND

  • 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.

    PMID: 27863515BACKGROUND

  • 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.

    PMID: 27265713BACKGROUND

  • 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.

    PMID: 27252778BACKGROUND

  • 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.

    PMID: 26428314BACKGROUND

  • 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.

    PMID: 26407793BACKGROUND

  • 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.

    PMID: 34138875DERIVED

  • 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.

    PMID: 32307009DERIVED

MeSH Terms

Conditions

DepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Mark van Ommeren, PhD

    World Health Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 20, 2018

Study Start

November 25, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

This will be shared for full trial.

Locations

NE(1)