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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+).

Publication ,  Journal Article
Sangraula, M; Van't Hof, E; Luitel, NP; Turner, EL; Marahatta, K; Nakao, JH; van Ommeren, M; Jordans, MJD; Kohrt, BA
Published in: Pilot Feasibility Stud
2018

BACKGROUND: The 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. METHODS: This 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. DISCUSSION: 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 c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03359486.

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Published In

Pilot Feasibility Stud

DOI

ISSN

2055-5784

Publication Date

2018

Volume

4

Start / End Page

126

Location

England

Related Subject Headings

  • 4203 Health services and systems
 

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Sangraula, M., Van’t Hof, E., Luitel, N. P., Turner, E. L., Marahatta, K., Nakao, J. H., … Kohrt, B. A. (2018). 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, 4, 126. https://doi.org/10.1186/s40814-018-0315-3
Sangraula, Manaswi, Edith Van’t Hof, Nagendra P. Luitel, Elizabeth L. Turner, Kedar Marahatta, Jolene H. Nakao, Mark van Ommeren, Mark J. D. Jordans, and Brandon A. Kohrt. “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 4 (2018): 126. https://doi.org/10.1186/s40814-018-0315-3.
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;4:126.
Journal cover image

Published In

Pilot Feasibility Stud

DOI

ISSN

2055-5784

Publication Date

2018

Volume

4

Start / End Page

126

Location

England

Related Subject Headings

  • 4203 Health services and systems