RecruitingNot ApplicableNCT07609550

Feasibility and Implementation of Early Referral in Perinatal Mental Health

Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study

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 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: FEMALEMin 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 women 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.