RecruitingNot ApplicableNCT07613008

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

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

Sponsor

University of Seville

Enrollment

3,000 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Perinatal Anxiety Perinatal Depression

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard routine maternal care and a behavioral approach called The e-Perinatal intervention is a personalized mobile health (mHealth) program for people with perinatal anxiety and perinatal depression. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALThe 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.

OTHERStandard 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.