Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders

This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.

NCT Number	NCT07613008
Lead Sponsor	University of Seville Collaborators: Junta de Andalucia, Health Service of Andalucia
Conditions	Perinatal Depression, Perinatal Anxiety
Enrollment	3,000 participants
Start Date	2026-07-15
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-16