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Life sciences · Interventional Study
ClinicalTrials.gov · September 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06640907). This is a study registration, not published results. Lead sponsor: University of Seville. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 96 participants (ACTUAL). Conditions: Perinatal Depression, Perinatal Anxiety. Interventions: BEHAVIORAL: e-Perinatal personalized mHealth intervention integrated into routine maternal care; OTHER: Standard routine maternal care with general perinatal health information. Primary outcome measures: Feasibility of the intervention , Measured at baseline and postintervention (2 months after baseline); Early acceptability , Measured at enrollment; Final acceptability , Measured at postintervention (2 months after baseline). Brief summary: 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.