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Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Sponsor: University of Seville
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.
Official title: Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-05-02
Completion Date
2025-12
Last Updated
2025-05-07
Healthy Volunteers
No
Conditions
Interventions
e-Perinatal personalized mHealth intervention integrated into routine maternal care
The e-Perinatal intervention combines a personalized mobile health (mHealth) app with targeted training for healthcare professionals to support perinatal mental health within routine maternal care. Participants allocated to the intervention arm will use the app for a period of two months. The app offers psychoeducational content, video-guided physical activities, mindfulness exercises, mood-tracking tools, personalized recommendations through a rule-based algorithm, and social-community features. Healthcare professionals assigned to the intervention arm receive specialized training to integrate the app into their daily practice, enhancing their ability to promote and support mental health during the perinatal period.
Standard routine maternal care with general perinatal health information
Standard maternal care as routinely provided by the Andalusian public healthcare system (Spain). This includes scheduled visits with midwives, nurses, and pediatrician for maternal and infant health monitoring, as well as access to childbirth education programmes. Participants also receive monthly psychoeducational emails (two months) containing general information on perinatal mental health, pregnancy, and infant development. Healthcare professionals in this arm do not receive specialized training in perinatal mental health or in the use of digital interventions, and participants do not have access to the e-Perinatal app.
Locations (1)
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
Mairena del Aljarafe, Seville, Spain