Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Seville
- Enrollment
- 3,000
- Locations
- 1
Study Overview
Brief Summary
This study is part of the e-Perinatal project and is embedded within the main cluster randomized trial. The primary aim is to evaluate the feasibility, acceptability, and preliminary effectiveness of an early diagnosis detection and referral strategy to specialized mental health services within routine maternal care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.
Detailed Description
This embedded study evaluates the implementation of the e-Perinatal app as a screening tool to facilitate early referral to specialized mental health services within routine primary healthcare settings.
The study will be conducted within the context of the main e-Perinatal trial in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women enrolled in the main study who are at risk of presenting maternal perinatal depression and/or anxiety disorders, based on a structured clinical interview.
The primary objective is to assess the feasibility and acceptability of an early referral in routine care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.
Data will be collected using questionnaires, clinical records, and semi-structured interviews with participants and healthcare professionals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Data analysts will also be masked.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant and postpartum women enrolled in the main e-Perinatal trial, indicating the presence of a depressive or anxiety disorder with CIDI.
- •Access to smartphone and internet
- •Able to write and read in Spanish
Exclusion Criteria
- •None beyond those defined in the main trial
Arms & Interventions
Intervention group
Intervention: The e-Perinatal intervention is a personalized mobile health (mHealth) program (Behavioral)
Control group
Intervention: Standard routine maternal care (Other)
Investigators
Emma Motrico
Professor of Psychology
University of Seville