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Multicenter Study
. 2019 May 14;9(5):e030259.
doi: 10.1136/bmjopen-2019-030259.

Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials

Marianna Purgato  1   2 , Kenneth Carswell  3 , Ceren Acarturk  4 , Teresa Au  3 , Sena Akbai  5 , Minna Anttila  6 , Josef Baumgartner  7 , Della Bailey  8 , Massimo Biondi  9 , Martha Bird  10 , Rachel Churchill  11 , Sevde Eskici  5 , Louise Juul Hansen  10 , Paul Heron  12 , Zeynep Ilkkursun  5 , Reinhold Kilian  13 , Markus Koesters  2   13 , Tella Lantta  14 , Michela Nosè  1   2 , Giovanni Ostuzzi  1   2 , Davide Papola  1   2 , Mariana Popa  15 , Marit Sijbrandij  16 , Lorenzo Tarsitani  9 , Federico Tedeschi  1 , Giulia Turrini  1   2 , Ersin Uygun  17 , Maritta Anneli Välimäki  6   18 , Johannes Wancata  19 , Ross White  15 , Elisa Zanini  1 , Pim Cuijpers  20 , Corrado Barbui  1   2 , Mark Van Ommeren  21
Affiliations
Multicenter Study

Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials

Marianna Purgato et al. BMJ Open. .

Abstract

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.

Keywords: asylum seekers; global mental health; psychosocial interventions; randomized controlled trials; refugees.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
RCT flow diagram. ETAU, enhanced treatment as usual; RCT, randomised controlled trial; SH+, Self-Help Plus.
See this image and copyright information in PMC

References

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