Evaluating a Personalized Mobile Health Program to Prevent Maternal Perinatal Depression and Anxiety and Its Use in Routine Maternal Care Settings

What this Trial Is About

Researchers are evaluating a personalized mobile health mHealth program called e-Perinatal designed to prevent maternal perinatal depression and anxiety disorders. This large-scale, cluster randomized controlled trial also explores effects on paternal mental health and child development, as well as how well the intervention can be implemented in real-world primary healthcare settings. The study is part of the ERC-funded e-Perinatal project and takes place in routine maternal care environments within primary healthcare centers. Participants are grouped by primary healthcare centers randomized to either receive the e-Perinatal intervention or continue with usual maternal care. Those in the intervention group get access to the e-Perinatal app, which offers digital micro-interventions in psychological support, physical activity, and healthy lifestyle, a personalized recommendation engine, social support features, mental health monitoring, an SOS button for assistance, and appointment reminders. The app is used from recruitment during pregnancy until 12 months postpartum. The control group receives standard maternal care including routine antenatal and postnatal visits and maternal education programs. During the study, participants will be assessed through structured diagnostic interviews to measure the cumulative incidence of maternal perinatal depression and anxiety disorders at baseline and 12 months postpartum. Maternal and paternal mental health symptoms, psychological wellbeing, and child development will be evaluated at multiple points including late pregnancy and several postpartum months. The study also tracks implementation outcomes like acceptability, feasibility, adoption, fidelity, and barriers in healthcare settings. Participation lasts from pregnancy through 12 months postpartum with regular mental health and wellbeing assessments.

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