Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers: the RE-DEFINE European randomized trial

This dataset contains data collected for the RE-DEFINE European randomised controlled trial which aimed to evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In this trial, SH+ was tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe. This prospective, multicentre, randomised, rater-blinded, parallel-group study followed participants over a period of 12 months. Six hundred 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, were randomly allocated to SH+ or to enhanced treatment-as-usual. The primary outcome was a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes included the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness. The trial received ethical clearance from the local Ethics Committees of the participating sites, as well as from the WHO Ethics Committee. All participants provided informed consent before screening and before study inclusion (a two-step procedure).