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

NCT07613008 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Perinatal Depression
  • Perinatal Anxiety

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.

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV

  • Health Service of Andalucia

    collaborator OTHER_GOV

  • University of Seville

    lead OTHER

Principal Investigators

  • Emma Motrico, PhD · University of Seville

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-12-30
Completion
2028-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613008 on ClinicalTrials.gov