Personalized mobile health support to prevent maternal depression and anxiety during pregnancy
Official title: Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
Run by University of Seville · NCT07613008 · Data updated 2026-11-12
A personalized mobile health program added to ordinary care is tested to see if it can prevent depression and anxiety in pregnant people and support partners.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | University of Seville Academic / other |
| Locations | 1 site (Mairena del Aljarafe, Sevilla) |
| Status | Recruiting |
| Started | July 15, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07613008 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals at or beyond 11 weeks gestation and their partners who have access to a smartphone and internet, read/write Spanish, and are invited by a participating clinic.
✕Probably not a fit
Pregnant individuals with existing depression or anxiety disorders or those not able to use mobile technology may derive little or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-arm, cluster-randomized study conducted in real-world primary care centers to test the e-Perinatal app as a universal prevention tool for perinatal mental health. The trial combines effectiveness and implementation questions, measuring rates of maternal perinatal depression and anxiety and related outcomes for fathers and children. It uses a hybrid type 1 design to look at how well the program works and how it can be put into routine care, including acceptability, feasibility, adoption, and fidelity. Participants are pregnant women (≥11 weeks) and their partners who are invited through participating clinics and who have access to a smartphone and internet. The intervention provides digital micro-interventions, a personalization engine, and lifestyle guidance via the e-Perinatal app alongside standard care. Outcomes will be assessed with structured diagnostic interviews and considered in the context of real-world implementation.
Why it matters
Potential benefit: If successful, the program could reduce the incidence of perinatal depression and anxiety and improve family and child outcomes by offering scalable, personalized digital support.
How similar studies have gone: Previous studies suggest digital preventive interventions can help with perinatal mental health, but this hybrid effectiveness-implementation approach in routine care is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Inclusion Criteria (Women) Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers Must be pregnant for at least 11 weeks at the time of 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 No diagnosis of depression or anxiety disorder at baseline Forma \- Inclusion Criteria (Partners or significant others) Must receive an invitation to participate from a woman already enrolled in the study 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 Exclusion Criteria: * Exclusion Criteria (Women) Current diagnosis of depression or anxiety disorder Receiving psychological or pharmacological treatment for mental health or substance use conditions \- Exclusion criteria for partners (or significant others): There are no exclusion criteria for partners
Where it's running
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Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
Mairena del Aljarafe, Sevilla, Spain Recruiting
Study contacts
- Principal investigator: Emma Motrico, PhD — University of Seville
- Study coordinator: Emma Motrico, PhD Psychology
- Email: eperinatal@us.es
- Phone: 0034636995778
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.