Journal Article

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

Barbui, Corrado, Ostuzzi, Giovanni, Carswell, Kenneth, Biondi, Massimo, Popa, Mariana, Baumgartner, Josef, Välimäki, Maritta Anneli, Hansen, Louise Juul, White, Ross, Anttila, Minna, Acarturk, Ceren, Bird, Martha, Zanini, Elisa, Cuijpers, Pim, Turrini, Giulia, Papola, Davide, Au, Teresa, Nosè, Michela, Tarsitani, Lorenzo, Bailey, Della, Purgato, Marianna, Heron, Paul, Uygun, Ersin, Lantta, Tella, Ilkkursun, Zeynep, Tedeschi, Federico, Eskici, Sevde, Sijbrandij, Marit, Akbai, Sena, Koesters, Markus, Van Ommeren, Mark, Wancata, Johannes, Churchill, Rachel, Kilian, Reinhold

2019

Overview

IntroductionThis 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 analysisTwo 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 disseminationThe 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 numbersNCT03571347, NCT03587896.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Anxiety / Cognitive Behavioral Therapy - economics / Cognitive Behavioral Therapy - statistics & numerical data / Community Mental Health Services - economics / Community Mental Health Services - statistics & numerical data / Community support / Cost analysis / Cost-Benefit Analysis / Delivery of Health Care - economics / Delivery of Health Care - statistics & numerical data / Europe - epidemiology / Evidence-based medicine / Female / Health Behavior / Health Services Needs and Demand / Humans / Intervention / Male / Mental disorders / Mental Disorders - diagnosis / Mental Disorders - epidemiology / Mental Disorders - therapy / Mental Health / Political asylum / Post traumatic stress disorder / Prospective Studies / Randomized Controlled Trials as Topic / Refugees / Refugees - psychology / Self help / Suicides & suicide attempts / Turkey - epidemiology / Well being