Condition: Perinatal Depression · Perinatal Anxiety · Sponsor: University of Seville
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.
This description comes directly from the study's public registry record.
Francisco J. Nieto-Casado, PhD in Psychology · 684785391 · eperinatal@us.es
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| Primary Health Care Center Mairena del Aljarafe - Ciudad Expo | Mairena del Aljarafe, Seville, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06640907