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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-17

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group problem management plus

Five sessions of group low intensity psychological intervention

Group Type EXPERIMENTAL

Group problem management plus

Intervention Type BEHAVIORAL

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

Enhanced treatment as usual

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

Group Type ACTIVE_COMPARATOR

Group problem management plus

Intervention Type BEHAVIORAL

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

Enhanced treatment as usual

Intervention Type BEHAVIORAL

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

Interventions

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Group problem management plus

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

Intervention Type BEHAVIORAL

Enhanced treatment as usual

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

Intervention Type BEHAVIORAL

Other Intervention Names

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mental health Gap Action Program-Implementation Guide

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No