Mobile health intervention for preventing perinatal mental disorders

Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)

This study is testing a new mobile app designed to help pregnant and new moms prevent mental health issues like depression and anxiety to see if it works better than regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Seville (other)
• Locations: 1 site (Mairena del Aljarafe, Seville)
• Trial ID: NCT06640907 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the feasibility and acceptability of the e-Perinatal app, a personalized mobile health intervention aimed at preventing perinatal mental disorders among pregnant and postpartum women. Conducted in primary healthcare centers in Andalusia, Spain, the study employs a two-arm, cluster-randomized design to compare the intervention with standard maternal care. Key outcomes include the app's integration into routine care, its acceptability among users, and preliminary effectiveness indicators such as the incidence of perinatal depression and anxiety. The findings will guide the design of a larger clinical trial to assess the intervention's overall effectiveness and cost-effectiveness.

Who should consider this trial

Good fit: Ideal candidates include pregnant women at least 16 weeks along or those who have given birth within the last 5 months, along with their partners, who can access mobile technology and understand Spanish.

Not a fit: Patients currently diagnosed with anxiety or depression, or those receiving psychological or pharmacological treatment, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of perinatal depression and anxiety, improving maternal and infant health outcomes.

How similar studies have performed: Other studies have shown promise in using mobile health interventions for mental health, suggesting potential success for this approach.

Eligibility criteria

Inclusion criteria for mothers:

* Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
* Must be pregnant for at least 16 weeks or have given birth within the last 5 months 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

Inclusion criteria for 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 for mothers:

* Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview
* Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition

Exclusion criteria for partners (or significant others):

* There are no exclusion criteria for partners

Where this trial is running

Mairena del Aljarafe, Seville

• Primary Health Care Center Mairena del Aljarafe - Ciudad Expo — Mairena del Aljarafe, Seville, Spain (RECRUITING)

Study contacts

• Study coordinator: Francisco J. Nieto-Casado, PhD in Psychology

Conditions: Perinatal Depression, Perinatal Anxiety, Depression, Anxiety, Perinatal, Well-being, Prevention, mHealth