Feasibility and Implementation of Early Referral in Perinatal Mental Health
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.
Conditions studied
Perinatal Depression, Perinatal Anxiety
About this study
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.
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.
Primary outcomes
- Feasibility of referral strategy (Baseline, 12 months postpartum)
- Acceptability of the referral (through study completion, an average of 18 months)
Eligibility information
Study locations
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo, Mairena del Aljarafe, Sevilla 41927 Spain
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.