Digital tool to support maternal mental health during pregnancy
Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | A Thousand Colibris, S.L Industry-sponsored |
| Locations | 3 sites (Barcelona, Catalonia and 2 other locations) |
| Trial ID | NCT06442774 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using digital tools for mental health monitoring, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Barcelona, Catalonia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.