Pilot Feasibility Study of Psychosocial Support to Improve Well-being of Adults in Humanitarian Crises in Nepal

NCT03359486 | Completed DMC

• 1 other identifier: ERC.0002817
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot feasibility 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 feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Depression - Patient Health Questionnaire

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

  1 week post-intervention

Secondary Outcomes (6)

• Daily functioning - World Health Organization Disability Assessment Scale

  1 week post-intervention

• General psychological distress - General Health Questionnaire

  1 week post-intervention

• Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist

  1 week post-intervention

• Personalized Measure of Distress - Psychological Outcome Profiles

  1 week post-intervention

• Culture-specific general psychological distress - Nepali Psychosocial and Mental Health Problems

  1 week post-intervention

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: Group problem management plus; Behavioral: Enhanced treatment as usual

Interventions

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; Group problem management plus

Enhanced treatment as usual BEHAVIORAL

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

• Age: 18 Years+
• Gender Eligibility Details: Self-reported gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• score \>2 on General Health Questionnaire (dichotomous item scoring method)
• 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)

Sponsors & Collaborators

• George Washington University: lead
• World Health Organization: collaborator
• Transcultural Psychosocial Organization Nepal: collaborator
• Duke University: collaborator
• King's College London: collaborator

Study Sites (1)

Transcultural Psychosocial Organization (TPO) Nepal

Kamalamai, Sindhuli, Nepal

Location

Related Publications (10)

• 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: 28809935 BACKGROUND

• 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: 28689511 BACKGROUND

• 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: 28603552 BACKGROUND

• 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: 28441974 BACKGROUND

• 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: 27863515 BACKGROUND

• 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: 27265713 BACKGROUND

• 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: 27252778 BACKGROUND

• 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: 26428314 BACKGROUND

• 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: 26407793 BACKGROUND

• Sangraula M, Van't Hof E, Luitel NP, Turner EL, Marahatta K, Nakao JH, van Ommeren M, Jordans MJD, Kohrt BA. Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+). Pilot Feasibility Stud. 2018 Jul 18;4:126. doi: 10.1186/s40814-018-0315-3. eCollection 2018.

  PMID: 30038793 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: November 26, 2017
• First Posted: December 2, 2017
• Study Start: December 17, 2017
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)