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Clinical Trials in Spain / NCT07609550
Recruiting Not applicable

Feasibility and Implementation of Early Referral in Perinatal Mental Health

NCT07609550 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-07-15
Last updated
2026-07-16

Condition(s) studied

Perinatal DepressionPerinatal Anxiety

Investigational drug(s) / intervention(s)

The e-Perinatal intervention is a personalized mobile health (mHealth) programStandard routine maternal care

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.

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.

Study summary

This study is part of the e-Perinatal project and is embedded within the main cluster randomized trial. The primary aim is to evaluate the feasibility, acceptability, and preliminary effectiveness of an early diagnosis detection and referral strategy to specialized mental health services within routine maternal care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Pregnant and postpartum women enrolled in the main e-Perinatal trial, indicating the presence of a depressive or anxiety disorder with CIDI. * Access to smartphone and internet * Able to write and read in Spanish Exclusion Criteria: * None beyond those defined in the main trial

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo Mairena del Aljarafe Sevilla Recruiting

More University of Seville trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07609550 on ClinicalTrials.gov ↗ ← All trials in Spain