학술논문
Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis
Document Type
Author
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; 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 J. D.; Kiselev, Nikolai; Knaevelsrud, Christine; Kurt, Gulsah; Martinmaki, 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
Source
BMJ Open. 12(4)
Subject
Language
English
ISSN
2044-6055
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.