Feasibility and Implementation of Early Referral in Perinatal Mental Health

NCT07609550 | Not Yet Recruiting

• 2 other identifiers: EP-WP3-2025_R101042139
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perinatal Depression; Perinatal Anxiety

Keywords

Depression; Anxiety; Perinatal; Referral; mHealth; Implementation

Outcome Measures

Primary Outcomes (2)

• Feasibility of referral strategy

  Assessment method: Recruitment rates, retention rates

  Baseline, 12 months postpartum

• Acceptability of the referral

  Acceptability of referral will be assessed using an ad hoc self-report assessment.

  through study completion, an average of 18 months

Secondary Outcomes (4)

• Identification of at-risk participants

  through study completion, an average of 18 months

• Referral to specialized mental health services

  through study completion, an average of 18 months

• Time to referral

  through study completion, an average of 18 months

• Engagement with mental health services

  through study completion, an average of 18 months

Other Outcomes (2)

• Follow-up period

  12 months

• Healthcare professional engagement

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program

Control group

ACTIVE COMPARATOR

Other: Standard routine maternal care

Interventions

The e-Perinatal intervention is a personalized mobile health (mHealth) program BEHAVIORAL

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.

Intervention group

Standard routine maternal care OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None beyond those defined in the main trial

Sponsors & Collaborators

• University of Seville: lead
• Andalusian Health Service: collaborator
• Junta de Andalucia: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Emma Motrico, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Motrico, PhD

CONTACT

0034636995778; eperinatal@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will also be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Nesed in Cluster-randomized hybrid type 1 effectiveness-implementation trial

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 27, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share