Digital tool to support maternal mental health during pregnancy
Official title: Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period
Run by A Thousand Colibris, S.L · NCT06442774 · Data updated 2026-11-12
This study is testing a new app to see if it can help pregnant women feel better and support their mental health during pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1200 (estimated) |
| Sponsor | A Thousand Colibris, S.L Industry-sponsored |
| Locations | 3 sites (Barcelona, Catalonia and 2 other locations) |
| Status | Recruiting |
| Started | December 28, 2024 |
| Main results expected | November 1, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | January 17, 2025 |
| Trial ID | NCT06442774 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women between 12-14 weeks of gestation who can read Spanish and have access to a smartphone.
✕Probably not a fit
Patients who have severe or unstable mental health conditions or those who have experienced perinatal loss may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to validate the Dana app, a digital health tool designed to enhance well-being and monitor mental health for women during the perinatal period. The study will compare outcomes between women using the app and a control group not using it, focusing on improvements in maternal well-being, early detection of mental health issues, and support for healthcare professionals in diagnosing these conditions. The app also seeks to improve obstetric outcomes and the psychological development of infants. Participants will be women between 12-14 weeks of gestation who can read Spanish and have access to a mobile phone.
Why it matters
Potential benefit: If successful, this app could significantly improve maternal mental health and well-being during and after pregnancy.
How similar studies have gone: Other studies have shown promise in using digital tools for mental health monitoring, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age between 12-14 weeks of gestation. * The first obstetric ultrasound has been performed. * Women who know how to read and understand Spanish. * Women who have access to a mobile phone with an internet connection (data or wifi) * Women who have knowledge of technology tools via app. * Have signed the informed consent to participate in the study. Exclusion Criteria: * Termination of pregnancy, or early miscarriage * Perinatal loss at any time during pregnancy. * Severe mental pathology or moderate unstable mental pathology. * Consumption of toxic substances.
Where it's running
-
Hospital Vall d'Hebron
Barcelona, Catalonia, Spain Recruiting -
Hospital del Mar
Barcelona, Spain Recruiting -
ASSIR Tarragona
Tarragona, Spain Recruiting
Study contacts
- Principal investigator: Roser Palau-Costafreda, PhD — A Thousand Colibris, S.L
- Study coordinator: Veronica Montesinos
- Email: veronica@athousandcolibris.com
- Phone: +34622353245
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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.