Actively Recruiting
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)
Led by University of Seville · Updated on 2025-05-07
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Seville
Lead Sponsor
H
Health Service of Andalucia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized mobile health (mHealth) intervention called the e-Perinatal app designed to prevent perinatal mental disorders in pregnant and postpartum women and their partners. This pilot study is part of the e-Perinatal project funded by the European Research Council and follows recommended phases for developing complex interventions. The study aims to assess feasibility, acceptability, and preliminary effectiveness within routine maternal care settings in Andalusia, Spain. Participants will be assigned by cluster randomization of primary healthcare centers to either the intervention or control group. The intervention group will use the e-Perinatal app for two months alongside standard maternal care. The app includes psychoeducational content, video-guided physical activities, mindfulness exercises, mood tracking, personalized recommendations, and social features. Healthcare professionals in this group receive special training to support app integration. The control group will receive standard maternal care and monthly psychoeducational emails about perinatal mental health and infant development. During the study, participants will be assessed at enrollment and two months later, with follow-up one month after that. Researchers will evaluate feasibility, acceptability, adoption, fidelity, and early indicators of effectiveness such as depressive and anxiety symptoms in women and their partners, and infant health outcomes. Data collection includes mood symptoms, well-being measures, and postnatal stress. The study will inform the design of a larger trial to evaluate effectiveness and cost-effectiveness of this intervention integrated into routine care.
CONDITIONS
Brief Title
Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must receive an invitation to participate from a healthcare professional at a participating primary healthcare center
- Must be pregnant for at least 16 weeks or have given birth within the last 5 months at 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
- Partners must be invited by a woman already enrolled
- Partners must be at least 18 years old
- Partners must have access to a mobile phone and internet
- Partners must be able to read, write, and understand Spanish
- Partners must have a personal email account
You will not qualify if you...
- Mothers meeting diagnostic criteria for anxiety or depression by structured clinical interview
- Mothers currently on or waiting for psychological or pharmacological treatment for any mental health or substance use condition
- There are no exclusion criteria for partners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants use the e-Perinatal app along with routine maternal care or receive standard maternal care with monthly psychoeducational emails for the prevention of perinatal mental disorders.
Monthly visits for 2 months
Duration - 1 month
Participants are monitored for mental health outcomes and well-being after completing the intervention period.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
Mairena del Aljarafe, Seville, Spain, 41927
Actively Recruiting
Research Team
F
Francisco J. Nieto-Casado, PhD in Psychology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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