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

Official title

Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial

Overview

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.

Detailed description

This clinical trial evaluates the effectiveness and implementation of the e-Perinatal intervention, a personalized mobile health (mHealth) psychological program designed for the universal prevention of maternal perinatal depression and anxiety disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 effectiveness-implementation trial in routine maternal care settings within primary healthcare centers.

Primary healthcare centers will be randomized to either the intervention or control arm. Participants will include pregnant women and their partners.

The primary objective is to evaluate the effectiveness of the e-Perinatal intervention in reducing the cumulative incidence of maternal perinatal depression and anxiety disorders, assessed via structured diagnostic interviews. Secondary objectives include assessing maternal and paternal mental health outcomes, child development outcomes, and identifying moderators and mediators of intervention effectiveness.

In addition, the study will evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, and barriers and facilitators to implementation in real-world healthcare settings.

Participants in the intervention group will receive access to the e-Perinatal app alongside usual maternal care. The e-Perinatal app 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. Participants in the control group will receive usual maternal care.

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
• 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 outcome measures

• Cumulative incidence of maternal perinatal depression and anxiety disorders [Time frame: Baseline and 12 months postpartum]

Secondary outcome measures (5)

• Maternal depressive symptoms (mothers) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum]

Eligibility criteria

Inclusion criteria

\- Inclusion Criteria (Women)

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

\- Inclusion Criteria (Partners or significant others)

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

Exclusion criteria

• Exclusion Criteria (Women)

Current diagnosis of depression or anxiety disorder

Receiving psychological or pharmacological treatment for mental health or substance use conditions

\- Exclusion criteria for partners (or significant others):

There are no exclusion criteria for partners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Spain · 1 center

• Primary Health Care Center Mairena del Aljarafe - Ciudad Expo — Mairena del Aljarafe

Identifiers

NCT: NCT07613008 · EP-WP3-2025 · 101042139

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗