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

This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021). The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.

NCT Number	NCT06640907
Lead Sponsor	University of Seville Collaborators: Health Service of Andalucia, Junta de Andalucia
Conditions	Perinatal Depression, Perinatal Anxiety
Enrollment	96 participants
Start Date	2025-05-02
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-05-07