Effectiveness, cost-effectiveness and implementation of WHO psychological interventions for migrant populations resettled in Italy: study protocol for the ADVANCE hybrid type-I randomized controlled trial

Introduction: Migrant populations are exposed to multiple psychosocial stressors throughout the migration process, increasing their risk for common mental health conditions. There is increasing evidence for psychological interventions amongst migrants, although intervention effects tend to attenuate over time and efficacy against placebo is unknown. At the same time, implementation science questions are becoming critical, such as the benefits of in-person and online psychological interventions. Methods and analysis: We present a study protocol for a randomized hybrid type-I effectiveness-implementation study that will enroll adult migrants resettled in Italy who experience elevated psychological distress. Participants (n = 237) will be randomized to receive either in-person Self-Help Plus (SH+) or online Doing What Matters in Times of Stress (DWM). We will assess the performance of both SH + and DWM with an additional booster session, and will compare them against a psychological placebo without active intervention ingredients. An intention-to-treat analysis using linear mixed models will be conducted to explore interventions' effects on depressive and anxiety symptoms at 3 months following randomization as measured by the Patient Health Questionnaire-Anxiety and Depression Scale, and to explore a set of implementation outcomes. We will also measure depressive symptoms, anxiety symptoms, mental health status, functioning, wellbeing, cost associated with care, quality of life, and self-stigma as secondary outcomes. Ethics and dissemination: The study protocol, informed consent procedures, and data protection measures were approved by the Comitato Etico Territoriale (CET) Area Sud Ovest Veneto (Approval ID n. 68505). The results of the present trial will be disseminated through the ADVANCE policy and scaling up strategy, in peer-reviewed journals, and at international and national scientific meetings. Trial registration number: ClinicalTrials.gov, identifier: NCT07209306.