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

N/ANot Yet RecruitingNCT07613008

University of Seville3,000 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

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

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 careOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cumulative incidence of maternal perinatal depression and anxiety disorders

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

Time frame: Baseline and 12 months postpartum

Secondary Outcomes

Maternal depressive symptoms (mothers)

Changes in depressive symptoms. Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure. Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.