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RECRUITING
NCT07613008
NA

Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders

Sponsor: University of Seville

View on ClinicalTrials.gov

Summary

This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.

Official title: Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2026-07-15

Completion Date

2028-03-30

Last Updated

2026-07-16

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

The e-Perinatal intervention is a personalized mobile health (mHealth) program

The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use the app from recruitment (pregnancy) until 12 months of postpartum.

OTHER

Standard routine maternal care

Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.

Locations (1)

Primary Health Care Center Mairena del Aljarafe - Ciudad Expo

Mairena del Aljarafe, Sevilla, Spain