1. Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis
- Author
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Pim Cuijpers, Kenneth Carswell, Ceren Acarturk, Martha Bird, Zeynep Ilkkursun, Marit Sijbrandij, Ersin Uygun, Bayard Roberts, Richard Bryant, Egbert Sondorp, David McDaid, Christine Knaevelsrud, Mark J D Jordans, A-La Park, Aemal Akhtar, Ulrich Schnyder, Sebastian Burchert, Trudy Mooren, Anke B Witteveen, Peter Ventevogel, Anne M de Graaff, Mhd Salem Alkneme, May Aoun, Manar Awwad, Ahmad Y Bawaneh, Felicity L Brown, Annelieke Drogendijk, Michelle Engels, Daniela C Fuhr, Pernille Hansen, Edith van 't Hof, Luana Giardinelli, Mahmoud Hemmo, Jonas M Hessling, Nikolai Kiselev, Gülsah Kurt, Saara Martinmäki, Naser Morina, Hadeel Naser, Monique C Pfaltz, Matthis Schick, Julia Spaaij, Frederik Steen, Karine Taha, Claire Whitney, Martine van den Dool, Cansu Mirzanlı, Nana Wiedemann, and Aniek Woodward
- Subjects
Medicine - Abstract
Introduction The World Health Organization’s (WHO) scalable psychological interventions, such as Problem Management Plus (PM+) and Step-by-Step (SbS) are designed to be cost-effective non-specialist delivered interventions to reduce symptoms of common mental disorders, such as anxiety, depression and post-traumatic stress disorder (PTSD). The STRENGTHS consortium aims to evaluate the effectiveness, cost-effectiveness and implementation of the individual format of PM+ and its group version (gPM+), as well as of the digital SbS intervention among Syrian refugees in seven countries in Europe and the Middle East. This is a study protocol for a prospective individual participant data (IPD) meta-analysis to evaluate (1) overall effectiveness and cost-effectiveness and (2) treatment moderators of PM+, gPM+ and SbS with Syrian refugees.Methods and analysis Five pilot randomised controlled trials (RCTs) and seven fully powered RCTs conducted within STRENGTHS will be combined into one IPD meta-analytic dataset. The RCTs include Syrian refugees of 18 years and above with elevated psychological distress (Kessler Psychological Distress Scale (K10>15)) and impaired daily functioning (WHO Disability Assessment Schedule 2.0 (WHODAS 2.0>16)). Participants are randomised into the intervention or care as usual control group, and complete follow-up assessments at 1-week, 3-month and 12-month follow-up. Primary outcomes are symptoms of depression and anxiety (25-item Hopkins Symptom Checklist). Secondary outcomes include daily functioning (WHODAS 2.0), PTSD symptoms (PTSD Checklist for DSM-5) and self-identified problems (PSYCHLOPS). We will conduct a one-stage IPD meta-analysis using linear mixed models. Quality of evidence will be assessed using the GRADE approach, and the economic evaluation approach will be assessed using the CHEC-list.Ethics and dissemination Local ethical approval has been obtained for each RCT. This IPD meta-analysis does not require ethical approval. The results of this study will be published in international peer-reviewed journals.
- Published
- 2022
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