Clinical trial NCT03359486: Pilot Feasibility Study of Psychosocial Support to Improve Well-being of Adults in Humanitarian Crises in Nepal
Official title: Pilot Feasibility Study of Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Transcultural Psychosocial Organization Nepal
name: Duke University
name: King's College London
First posted: 2017-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. In this project Group PM+ will be piloted in a district in Nepal, which was affected by the 2015 earthquakes in Nepal. The current pilot study will evaluate the acceptability and feasibility of Group PM+ in Nepal to informant a subsequent pragmatic cluster randomized controlled trial. This exploratory cluster randomized controlled trial (cluster randomized controlled trial) will be 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. This research strategy is informed by the United Kingdom Medical Research Council framework for the development of complex interventions, which recognizes iterations of: a) Intervention Development; b) Feasibility and Piloting; c) Evaluation; and d) Implementation. This framework recommends to first conduct feasibility and randomized pilot studies before conducting large scale trials. In this way possible problems of acceptability, compliance, delivery of the intervention, recruitment and retention can be detected before the large definitive scale trail is conducted.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Depression - Patient Health Questionnaire
timeFrame: 1 week post-intervention
Secondary outcomes:
measure: Daily functioning - World Health Organization Disability Assessment Scale
timeFrame: 1 week post-intervention
measure: General psychological distress - General Health Questionnaire
timeFrame: 1 week post-intervention
measure: Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist
timeFrame: 1 week post-intervention
measure: Personalized Measure of Distress - Psychological Outcome Profiles
timeFrame: 1 week post-intervention
measure: Culture-specific general psychological distress - Nepali Psychosocial and Mental Health Problems
timeFrame: 1 week post-intervention
measure: Reducing Tension Checklist for Problem Management Plus Skills
timeFrame: 1 week post-intervention
Other outcomes:
Locations:
city: Kamalamai
country: Nepal
facility: Transcultural Psychosocial Organization (TPO) Nepal
state: Sindhuli
Study officials:
affiliation: World Health Organization
name: Mark van Ommeren, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.