Actively Recruiting
Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Led by University of Seville · Updated on 2025-05-07
96
Participants Needed
1
Research Sites
30 weeks
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
This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021). The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.
CONDITIONS
Official 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...
- Pregnant women at least 16 weeks into pregnancy or postpartum women up to 5 months after birth
- Women at least 18 years old
- Have access to a mobile phone and internet connection
- Able to read, write, and understand Spanish
- Have a personal email account
- Must receive an invitation from a healthcare professional at a participating primary healthcare center
- Partners must be invited by a woman already enrolled in the study
- Partners must be at least 18 years old
- Partners must have access to a mobile phone and internet connection
- Partners must be able to read, write, and understand Spanish
- Partners must have a personal email account
You will not qualify if you...
- Women diagnosed with anxiety or depression by a structured clinical interview
- Women currently on a waiting list or receiving psychological or pharmacological treatment for mental health or substance use conditions
- There are no exclusion criteria for partners
AI-Screening
AI-Powered Screening
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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
CONTACT
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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