Pilot Study of the e-Perinatal Mobile Health App for Preventing Perinatal Depression and Anxiety Evaluating Feasibility and Acceptance in Pregnant and Postpartum Women and Their Partners

What this Trial Is About

Researchers are evaluating a personalized mobile health mHealth intervention called the e-Perinatal app designed to prevent perinatal mental disorders in pregnant and postpartum women and their partners. This pilot study is part of the e-Perinatal project funded by the European Research Council and follows recommended phases for developing complex interventions. The study aims to assess feasibility, acceptability, and preliminary effectiveness within routine maternal care settings in Andalusia, Spain. Participants will be assigned by cluster randomization of primary healthcare centers to either the intervention or control group. The intervention group will use the e-Perinatal app for two months alongside standard maternal care. The app includes psychoeducational content, video-guided physical activities, mindfulness exercises, mood tracking, personalized recommendations, and social features. Healthcare professionals in this group receive special training to support app integration. The control group will receive standard maternal care and monthly psychoeducational emails about perinatal mental health and infant development. During the study, participants will be assessed at enrollment and two months later, with follow-up one month after that. Researchers will evaluate feasibility, acceptability, adoption, fidelity, and early indicators of effectiveness such as depressive and anxiety symptoms in women and their partners, and infant health outcomes. Data collection includes mood symptoms, well-being measures, and postnatal stress. The study will inform the design of a larger trial to evaluate effectiveness and cost-effectiveness of this intervention integrated into routine care.

Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)