Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders

NCT07613008 | Not Yet Recruiting

• 2 other identifiers: EP-WP3-2025101042139
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.

Conditions

Perinatal Depression; Perinatal Anxiety

Keywords

Depression; Anxiety; Perinatal; Prevention; mHealth; Implementation

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of maternal perinatal depression and anxiety disorders

  Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria

  Baseline and 12 months postpartum

Secondary Outcomes (5)

• Maternal depressive symptoms (mothers)

  Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum

• Maternal anxiety symptoms (mothers)

  Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum

• Paternal depressive symptoms (partner)

  Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum

• Paternal anxiety symptoms (partner)

  Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum

• Psychological well-being (mothers, partners)

  Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum

Other Outcomes (27)

• Organizational readiness for implementing change

  Measured before recruitment

• App quality (mothers, partners)

  12 months postpartum

• Implementation process

  12 months postpartum

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: Standard routine maternal care

Intervention group

EXPERIMENTAL

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

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

You may qualify if:

• Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
• Must be pregnant for at least 11 weeks at the time of enrollment
• Must be at least 18 years old
• Must have access to a mobile phone and internet connection
• Must be able to read, write, and understand Spanish
• Must have a personal email account
• No diagnosis of depression or anxiety disorder at baseline Forma
• Must receive an invitation to participate from a woman already enrolled in the study
• Must be at least 18 years old
• Must have access to a mobile phone and internet connection
• Must be able to read, write, and understand Spanish
• Must have a personal email account

You may not qualify if:

• Current diagnosis of depression or anxiety disorder
• Receiving psychological or pharmacological treatment for mental health or substance use conditions

Sponsors & Collaborators

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

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: Cluster-randomized hybrid type 1 effectiveness-implementation trial

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 29, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share