Introduction This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.
Methods and analysis Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness.
Ethics and dissemination The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings.
Trials registration numbers NCT03571347, NCT03587896.
- randomized controlled trials
- psychosocial interventions
- asylum seekers
- global mental health
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Contributors The study was conceived and designed by MvO and CB. MP and CB drafted the manuscript. CA, TA, KC, MN, GO, FT, GT and MvO contributed to the study design and commenting/editing the manuscript drafts. SA, MA, JB, DB, MB, MBirth, RC, SE, LJH, PH, ZI, RK, MK, TL, DP, MP, MS, LT, EU, MV, JW, RW, EZ, PC provided comments/revisions to the manuscript drafts.
Funding This work is supported by the European Commission, grant agreement n. 779255 “RE-DEFINE: Refugee Emergency: DEFining and Implementing Novel Evidence-based psychosocial interventions”. The funder had no role in study design, and will have no role in data management, analysis, interpretation of data, writing the report and the decision to submit the report for publication nor ultimate authority over any of the listed activities. EU will have the possibility to audit the financial project management, while for the scientific part deliverables and milestones are being provided to the EU according to the grant agreement.
Disclaimer The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated.
Competing interests None declared.
Ethics approval The study protocols have been approved by: Local Ethics Committees and WHO ERC: Verona: Comitato Etico per la Sperimentazione Clinica delle province di Verona e Rovigo; Approval ID 1682CESC Ulm: Furdie Ethikkommission der Universitat Ulm; Approval ID 93/18 Vienna: Ethik Kommission, University of Vienna; Approval ID 1199/2018 Liverpool: Central University Research Ethics Committee B; Approval ID 3198 York: Health Sciences Research Governance Committee; Approval 16-03-2018 Turku: Varsinais-Suomen sairaanhoitopiirin kuntayhtymä Eettinen toimikunta; Approval ID 19/1801/2018 Istanbul: Istanbul Sehir Universitesi; Approval 8-03-2018 WHO: WHO ERC Ethics Committee Approval ID: ERC.0003021
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
Patient consent for publication Not required.