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01-12-2020 | Affective Disorder | Study protocol

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey

Authors: Ersin Uygun, Zeynep Ilkkursun, Marit Sijbrandij, A. Tamer Aker, Richard Bryant, Pim Cuijpers, Daniela C. Fuhr, Anne M. de Graaff, Joop de Jong, David McDaid, Naser Morina, A-La Park, Bayard Roberts, Peter Ventevogel, Taylan Yurtbakan, Ceren Acarturk, On behalf of the STRENGHTS consortium

Published in: Trials | Issue 1/2020

Abstract

Background

A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, and breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post-migration living difficulties such as discrimination or integration problems or both. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community.

Methods

A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring above 15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring above 16 on the WHO Disability Assessment Schedule 2.0, or WHODAS 2.0) will be randomly assigned to Group PM+/enhanced care as usual (Group PM+/E-CAU) (n = 190) or E-CAU (n = 190). Outcome assessments will take place 1 week after the fifth session (post-assessment), 3 months after the fifth session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, post-traumatic stress symptoms, self-identified problems, and health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants, including participants, facilitators, policy makers and mental health professionals.

Discussion

The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of Group PM+ have been established.

Trial registration

Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03960892. Unique protocol ID: 10/2017. Prospectively registered on 21 May 2019.

Available only for authorised users

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Title: Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey
Authors: Ersin Uygun
Zeynep Ilkkursun
Marit Sijbrandij
A. Tamer Aker
Richard Bryant
Pim Cuijpers
Daniela C. Fuhr
Anne M. de Graaff
Joop de Jong
David McDaid
Naser Morina
A-La Park
Bayard Roberts
Peter Ventevogel
Taylan Yurtbakan
Ceren Acarturk
On behalf of the STRENGHTS consortium
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Affective Disorder
Behavioural Therapy
Affective Disorder
Anxiety
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-4166-x

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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