An interventional study of The e-Perinatal intervention is a personalized mobile health (mHealth) program and Standard routine maternal care in Perinatal Depression and Perinatal Anxiety, sponsored by University of Seville. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Seville · Not applicable, Interventional, and Prevention
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program
Other: Standard routine maternal care
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 the app from recruitment (pregnancy) until 12 months of postpartum.
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.
Feasibility of referral strategy
Assessment method: Recruitment rates, retention rates
Time frame: Baseline, 12 months postpartum
Acceptability of the referral
Acceptability of referral will be assessed using an ad hoc self-report assessment.
Time frame: through study completion, an average of 18 months
Identification of at-risk participants
Measure of the number of at-risk participants. Participants will be considered at risk if they score above the clinical cutoff on at least one of the two scales (Edinburgh Postnatal Depression Scale (EPDS) ≥ 12 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10), measuring the severity of the depression and anxiety symptoms, respectively. EPDS and GAD-7 will be collected within the e-Perinatal app.
Time frame: through study completion, an average of 18 months
Referral to specialized mental health services
Number of referral to specialized mental health services, as recorded in clinical records.
Time frame: through study completion, an average of 18 months
Time to referral
Assessment method: Time between identification and referral
Time frame: through study completion, an average of 18 months
Engagement with mental health services
Number of accesses to specialized mental health services, as recorded in clinical records.
Time frame: through study completion, an average of 18 months
Follow-up period
Assessment method: Semi-structured interviews (Normalization Process Theory)
Time frame: 12 months
Healthcare professional engagement
Assessment method: semi-structured interviews
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 17 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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