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EV0776

Implementing the WHO Thinking Healthy Programme for perinatal depression among migrant women in Italy: a randomized controlled trial protocol

THINKING HEALTHY PROGRAMME FOR PERINATAL DEPRESSION IN MIGRANT WOMEN IN ITALY: PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL

This protocol describes a randomized controlled trial comparing the effectiveness, feasibility, and acceptability of a culturally adapted WHO Thinking Healthy Programme with treatment as usual for perinatal depression among migrant women in southern Italy.

Perinatal depression can affect maternal health and infant development, while social exclusion and limited support restrict migrant women's access to care; the poster reports a worldwide prevalence of 10% to 15% and a prevalence of 25% to 30% among migrant women. The study aims to evaluate the WHO Thinking Healthy Programme (THP) in terms of clinical effectiveness, feasibility, and acceptability compared with treatment as usual (TAU). According to the protocol, 60 migrant women will be recruited through community services and reception centers. Women aged 18 to 45 who score between 10 and 19 on the Edinburgh Postnatal Depression Scale (EPDS), have lived in Italy for less than 10 years, and are pregnant or up to 12 months postpartum will be randomized in a 1:1 ratio. The THP arm will receive 10 individual and 4 group sessions; the programme is a culturally and linguistically adapted, manual-based, low-intensity intervention grounded in cognitive behavioral therapy (CBT), incorporating behavioral activation and problem-solving and delivered by supervised non-specialists. The primary outcome is the change in EPDS score from baseline to 3 months; secondary outcomes are assessed using the GAD-7 for anxiety, WHODAS 2.0, and the Mother-to-Infant Bonding Scale (MIBS); implementation outcomes include recruitment and participation rates, satisfaction, and interviews. A safety pathway has been defined that includes referral to specialist mental health services in cases of severe symptoms, suspected major depression, or suicidal ideation. The study is expected to provide evidence from Italy on the effectiveness, feasibility, acceptability, and scalability of culturally sensitive THP for migrant women.

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