BMJ Open (Apr 2022)

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

  • ,
  • 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,
  • Aniek Woodward

DOI
https://doi.org/10.1136/bmjopen-2021-058101
Journal volume & issue
Vol. 12, no. 4

Abstract

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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.