Feasibility and Implementation of Early Referral in Perinatal Mental Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The e-Perinatal intervention is a personalized mobile health (mHealth) program, Standard routine maternal care.
- Who it may be relevant to
- Registry conditions: Perinatal Depression, Perinatal Anxiety. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study
Overview
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.
Interventions
- Behavioral The e-Perinatal intervention is a personalized mobile health (mHealth) program
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 - Other Standard routine maternal care
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.
Primary outcome measures
- Feasibility of referral strategy [Time frame: Baseline, 12 months postpartum]
- Acceptability of the referral [Time frame: through study completion, an average of 18 months]
Secondary outcome measures (4)
- Identification of at-risk participants [Time frame: through study completion, an average of 18 months]
- Referral to specialized mental health services [Time frame: through study completion, an average of 18 months]
- Time to referral [Time frame: through study completion, an average of 18 months]
- Engagement with mental health services [Time frame: through study completion, an average of 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo — Mairena del Aljarafe
Identifiers
NCT: NCT07609550 · EP-WP3-2025_R · 101042139