Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07609550

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Perinatal Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Perinatal Anxiety

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Care Center Mairena del Aljarafe - Ciudad Expo

Mairena del Aljarafe, Sevilla, 41927, Spain

Location status: Recruiting

Location contact

Ana Belén Naranjo Saucedo,, MSc

CONTACT

[email protected]

+34 676426430

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility of referral strategy

    Time frame: Baseline, 12 months postpartum

    Assessment method: Recruitment rates, retention rates

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Time to referral

    Time frame: through study completion, an average of 18 months

    Assessment method: Time between identification and referral

  4. 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.

Other outcomes

  1. Follow-up period

    Time frame: 12 months

    Assessment method: Semi-structured interviews (Normalization Process Theory)

  2. Healthcare professional engagement

    Time frame: 12 months

    Assessment method: semi-structured interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Motrico, PhD

CONTACT

[email protected]

0034636995778

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Andalusian Health Service
  • Junta de Andalucia

Registry information

Official study title

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

Acronym: e-Perinatal-Re

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 27, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.