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

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Marianna Purgato - , University of Verona, Cochrane Global Mental Health (Author)
  • Kenneth Carswell - , World Health Organization (Author)
  • Ceren Acarturk - , Istanbul Sehir University (Author)
  • Teresa Au - , World Health Organization (Author)
  • Sena Akbai - , Istanbul Sehir University (Author)
  • Minna Anttila - , University of Turku (Author)
  • Josef Baumgartner - , Medical University of Vienna (Author)
  • Della Bailey - , University of York (Author)
  • Massimo Biondi - , University of Rome La Sapienza (Author)
  • Martha Bird - , IFRC Psychosocial centre (Author)
  • Rachel Churchill - , University of York (Author)
  • Sevde Eskici - , Istanbul Sehir University (Author)
  • Louise Juul Hansen - , IFRC Psychosocial centre (Author)
  • Paul Heron - , University of York (Author)
  • Zeynep Ilkkursun - , Istanbul Sehir University (Author)
  • Reinhold Kilian - , Ulm University (Author)
  • Markus Koesters - , Cochrane Global Mental Health, Ulm University (Author)
  • Tella Lantta - , University of Turku (Author)
  • Michela Nosè - , University of Verona, Cochrane Global Mental Health (Author)
  • Giovanni Ostuzzi - , University of Verona, Cochrane Global Mental Health (Author)
  • Davide Papola - , University of Verona, Cochrane Global Mental Health (Author)
  • Mariana Popa - , University of Liverpool (UOL) (Author)
  • Marit Sijbrandij - , Vrije Universiteit Amsterdam (VU) (Author)
  • Lorenzo Tarsitani - , University of Rome La Sapienza (Author)
  • Federico Tedeschi - , University of Verona (Author)
  • Giulia Turrini - , University of Verona, Cochrane Global Mental Health (Author)
  • Ersin Uygun - , Istanbul Bilgi University (Author)
  • Maritta Anneli Välimäki - , University of Turku, Hong Kong Polytechnic University (Author)
  • Johannes Wancata - , Medical University of Vienna (Author)
  • Ross White - , University of Liverpool (UOL) (Author)
  • Elisa Zanini - , University of Verona (Author)
  • Pim Cuijpers - , Vrije Universiteit Amsterdam (VU) (Author)
  • Corrado Barbui - , University of Verona, Cochrane Global Mental Health (Author)
  • Mark Van Ommeren - , World Health Organization (Author)

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.

Details

Original languageEnglish
Article number030259
JournalBMJ open
Volume9
Issue number5
Publication statusPublished - 1 May 2019
Peer-reviewedYes
Externally publishedYes

External IDs

PubMed 31092670
ORCID /0000-0001-7018-6021/work/168207930

Keywords

ASJC Scopus subject areas

Keywords

  • Asylum seekers, Global mental health, Psychosocial interventions, Randomized controlled trials, Refugees