Scalable psychological interventions for Syrian refugees in Europe and the Middle East : STRENGTHS study protocol for a prospective individual participant data meta- analysis

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.