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.

Reference: 
Anne M de Graaff, Pim Cuijpers, Ceren Acarturk, Aemal Akhtar, Salem Alkneme, May Aoun, Manar Awwad, Ahmad Y Bawaneh, Felicity L Brown, Richard Bryant, Alkneme, Mhd Salem, Sebastian Burchert, Kenneth Carswell, Annelieke Drogendijk, Michelle Engels, Daniela C Fuhr, Pernille Hansen, Edith van 't Hof, Luana Giardinelli, Mahmoud Hemmo, Jonas M Hessling, Zeynep Ilkkursun, Mark J D Jordans, Nikolai Kiselev, Christine Knaevelsrud, Gülsah Kurt, Saara Martinmäki, David McDaid, Naser Morina, Hadeel Naser, A-La Park, Monique C Pfaltz, Bayard Roberts, Matthis Schick, Ulrich Schnyder, Julia Spaaij, Frederik Steen, Karine Taha, Ersin Uygun, Peter Ventevogel, Claire Whitney, Anke B Witteveen, Marit Sijbrandij. On behalf of the STRENGTHS consortium | 2022
In: BMJ Open ; ISSN: 2044-6055 | 12 | 4 | April | e058101
http://dx.doi.org/10.1136/bmjopen-2021-058101
Keywords: 
Anxiety Disorders, Depressive Disorders, Disability, Economics, Effectiveness, Europeans, Followup Study, Mental health, Mental Health Personnel, Meta Analysis, Middle East, Mood Disorders, Nongovernmental Organizations, Posttraumatic Stress Disorder, Psychoeducation, Psychotrauma, PTSD (DSM-5), PTSD (en), Randomized Clinical Trial, Syrians, Treatment
Affiliation author(s): 
ARQ National Psychotrauma Centre