Feasibility and Implementation of Early Referral in Perinatal Mental Health (e-Perinatal-Re)

May 19, 2026 updated by: Emma Motrico, University of Seville

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This embedded study evaluates the implementation of the e-Perinatal app as a screening tool to facilitate early referral to specialized mental health services within routine primary healthcare settings.

The study will be conducted within the context of the main e-Perinatal trial in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women enrolled in the main study who are at risk of presenting maternal perinatal depression and/or anxiety disorders, based on a structured clinical interview.

The primary objective is to assess the feasibility and acceptability of an early referral in routine 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.

Data will be collected using questionnaires, clinical records, and semi-structured interviews with participants and healthcare professionals.

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Active Comparator: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of referral strategy
Time Frame: Baseline, 12 months postpartum
Assessment method: Recruitment rates, retention rates
Baseline, 12 months postpartum
Acceptability of the referral
Time Frame: through study completion, an average of 18 months
Acceptability of referral will be assessed using an ad hoc self-report assessment.
through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of at-risk participants
Time Frame: through study completion, an average of 18 months
Measure of the number of at-risk participants. Participants will be considered at risk if they score above the clinical cutoff on at least one of the two scales (Edinburgh Postnatal Depression Scale (EPDS) ≥ 12 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10), measuring the severity of the depression and anxiety symptoms, respectively. EPDS and GAD-7 will be collected within the e-Perinatal app.
through study completion, an average of 18 months
Referral to specialized mental health services
Time Frame: through study completion, an average of 18 months
Number of referral to specialized mental health services, as recorded in clinical records.
through study completion, an average of 18 months
Time to referral
Time Frame: through study completion, an average of 18 months
Assessment method: Time between identification and referral
through study completion, an average of 18 months
Engagement with mental health services
Time Frame: through study completion, an average of 18 months
Number of accesses to specialized mental health services, as recorded in clinical records.
through study completion, an average of 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up period
Time Frame: 12 months
Assessment method: Semi-structured interviews (Normalization Process Theory)
12 months
Healthcare professional engagement
Time Frame: 12 months
Assessment method: semi-structured interviews
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Collaborators

Junta de Andalucia
Andalusian Health Service

Investigators

  • Principal Investigator: Emma Motrico, PhD, University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-WP3-2025_R
  • 101042139 (Other Identifier: European Research Council (ERC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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