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+)

Manaswi Sangraula,Elizabeth L Turner,Mark Van Ommeren,Jolene H Nakao,Brandon A Kohrt,Nagendra P Luitel,Kedar Marahatta,Mark J D Jordans,Edith Van’T Hof

doi:10.1186/s40814-018-0315-3

Abstract

BackgroundThe prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. To make PM+ more scalable and acceptable in different contexts, it is important to develop a group version as well, with 6–8 participants in session. A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial.MethodsThis protocol describes a feasibility trial to Group PM+ in Sindhuli, Nepal. This study will evaluate procedures for a cluster randomized controlled trial (c-RCT) with Village Development Committees (VDCs), which are the second smallest unit of government administration, as the unit of randomization. Adults with high levels of psychological distress and functional impairment will receive either Group PM+ (n = 60) or enhanced usual care (EUC; n = 60). Psychological distress, functional impairment, depression symptoms, posttraumatic stress disorder (PTSD) symptoms, and perceived problems will be measured during screening, pre-treatment baseline, and 7–10 days after the intervention. Qualitative data will be collected from beneficiaries, their families, local stakeholders, and staff to support quantitative data and to identify themes reporting that those involved and/or effected by Group PM+ perceived it as being acceptable, feasible, and useful. The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention; to identify issues around implementation of local adaptation methods, training, supervision, and outcomes measures; and to assure that procedures are adequate for a subsequent effectiveness c-RCT.DiscussionOutcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal.Trial registrationClinicalTrials.gov identifier: NCT03359486

Highlights

The prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases
Sangraula et al Pilot and Feasibility Studies (2018) 4:126 (Continued from previous page). Outcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a cluster randomized controlled trial (c-randomized controlled trials (RCTs)), which will evaluate the effectiveness of Group PM+ in Nepal
In low-resource settings, mental health interventions may need to be short of duration and carried out by non-specialists in the communities to make them sustainable and feasible to implement on a broader scale

Summary

Introduction

A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial Humanitarian crises, such as the earthquake in Nepal in April 2015, cause significant psychological and social suffering. It has four core features that make the intervention suitable for low-resource settings exposed to adversities: a brief intervention (five sessions) (1) delivered individually or in groups; (2) delivered by non-specialists (high school graduates with no mental health experience), using the principle of task shifting; (3) designed as a trans-diagnostic intervention, addressing a range of client-identified emotional (e.g., depression, anxiety, stress) and practical problems; and (4) designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity (e.g., violence, disasters) [2]

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