Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis.
de Graaff, Anne M;
Cuijpers, Pim;
Acarturk, Ceren;
Akhtar, Aemal;
Alkneme, Mhd Salem;
Aoun, May;
Awwad, Manar;
Bawaneh, Ahmad Y;
Brown, Felicity L;
Bryant, Richard;
+33 more...Burchert, Sebastian;
Carswell, Kenneth;
Drogendijk, Annelieke;
Engels, Michelle;
Fuhr, Daniela C;
Hansen, Pernille;
van 't Hof, Edith;
Giardinelli, Luana;
Hemmo, Mahmoud;
Hessling, Jonas M;
Ilkkursun, Zeynep;
Jordans, Mark JD;
Kiselev, Nikolai;
Knaevelsrud, Christine;
Kurt, Gülsah;
Martinmäki, Saara;
McDaid, David;
Morina, Naser;
Naser, Hadeel;
Park, A-La;
Pfaltz, Monique C;
Roberts, Bayard;
Schick, Matthis;
Schnyder, Ulrich;
Spaaij, Julia;
Steen, Frederik;
Taha, Karine;
Uygun, Ersin;
Ventevogel, Peter;
Whitney, Claire;
Witteveen, Anke B;
Sijbrandij, Marit;
STRENGTHS consortium;
(2022)
Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis.
BMJ Open, 12 (4).
e058101-.
ISSN 2044-6055
DOI: https://doi.org/10.1136/bmjopen-2021-058101
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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.
