THE RE-DEFINE PROJECT AND THE EFFECTIVENESS OF SH+ IN PREVENTING MENTAL DISORDERS IN REFUGEES AND ASYLUM SEEKERS RESETTLED IN EUROPE: A MULTICENTRE RANDOMISED CONTROLLED TRIAL

Background: The RE-DEFINE project aims to provide effective community-based health care implementation strategies to scale-up the delivery and uptake of psychosocial interventions for preventing the onset of mental disorders in refugees and asylum seekers (RAS) resettled in middle-income and in high-income countries (HICs). Self Help Plus (SH+) is a group-based psychosocial intervention developed by the World Health Organization for managing psychological distress in conditions of adversity. RE-DEFINE aimed to assess the effectiveness of SH+ in preventing the development of mental disorders in RAS resettled in Europe. Methods: A randomized controlled trial was conducted at six sites in five European countries. Participants were adult asylum seekers and refugees with psychological distress (General Health Questionnaire ≥ 3), but without a formal psychiatric diagnosis as assessed with the Mini International Neuropsychiatric Interview (M.I.N.I.). The intervention comprised five group-based audio-recorded sessions on stress management, complemented with an illustrated book. Sessions were led by peer-facilitators receiving appropriate training. Participants were randomized to either SH+ or treatment as usual (TAU) on a 1:1 basis. The frequency of any mental disorder was measured with the M.I.N.I. at post-intervention (secondary outcome) and six months after start of the intervention (primary outcome) in the intention-to-treat population. Secondary outcomes also included self-identified problems, symptoms of depression and post-traumatic stress disorder, functional impairment, quality of life, and subjective wellbeing at post-intervention and at six-month follow-up. Assessors were masked to allocation. Findings: Of 1475 individuals assessed for eligibility, 459 were included in the trial and randomly assigned to SH+ or TAU. Compared with controls, we found lower incidence of any mental disorders at post-intervention for SH+ (Cramer’s V 0.13, p= 0.01, Risk Ratio (RR) 0.50, 95% Confidence Interval (CI) 0.29 to 0.87), but not at follow-up (Cramer’s V 0.007, p= 0.90, RR 0.96, 95% CI 0.52 to 1.78). We also found statistically significant improvements for SH+ for four out of six secondary outcomes at post-intervention, and for the outcome wellbeing at six-month follow-up. Eight adverse events were reported, none of which was considered to be associated with the intervention. Interpretation: This is the first study showing that it is possible to prevent the development of mental disorders in asylum seekers and refugees resettled in HICs. As the preventative effect was observed at post-intervention only, modalities to maintain the beneficial effect of SH+ in the long-term need to be identified. SH+ may be safely offered as a public health indicated prevention strategy to RAS resettled in HICs.