Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Recruiting now · Not applicable
Conditions studied: Perinatal Depression, Perinatal Anxiety
In brief
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.
Key facts
- Study ID
- NCT06640907
- Run by
- University of Seville
- People needed
- 96
- Starts
- 2025-05-02
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo — Mairena del Aljarafe, Seville, Spain (enrolling)
Full record on ClinicalTrials.gov
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