HappyMums mobile app for monitoring mood during pregnancy
HappyMums - Can Data Collected by a Mobile App be Used to Help Learn More About Mental Health Symptoms in Pregnant Women and Birthing People at Risk of Depression in Pregnancy?
This project will test whether the HappyMums app is acceptable and usable for pregnant people at risk of or experiencing antenatal depression by collecting active and passive phone data to see if it helps spot changes in mood.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | King's College London Academic / other |
| Locations | 7 sites (Zagreb and 6 other locations) |
| Trial ID | NCT06578845 on ClinicalTrials.gov |
What this trial studies
HappyMums is an observational, multicenter effort using a smartphone app to collect passive sensor data (GPS, phone usage, step counts) and active user inputs, including game-like activities, a wellbeing course, and mood/health logging, from pregnant people up to 28 weeks' gestation. Participants will use the app during pregnancy and researchers will aggregate the collected data to develop retrospective statistical models of antenatal depression trajectories. The main aims are to test acceptability and usability of the app and to explore whether combined data types can help identify changes in mental health over time. Recruitment and data collection occur across European sites affiliated with the study team.
Who should consider this trial
Good fit: Pregnant people aged 18 or older and up to 28 weeks' gestation who own a compatible smartphone and have current depressive symptoms or at least one risk factor for antenatal depression are ideal candidates.
Not a fit: People beyond 28 weeks' gestation, those without a compatible smartphone, those unable to give informed consent, or those who prefer non-digital care are unlikely to benefit from this app-based approach.
Why it matters
Potential benefit: If successful, the app could enable earlier detection of worsening mood in pregnancy and support more personalized monitoring and treatment decisions.
How similar studies have performed: Similar digital mental-health and passive-sensor monitoring projects have shown promise in detecting mood changes in perinatal and general populations, but predictive algorithms remain experimental and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant people, aged 18 or older and up to 28 weeks' gestation. * Satisfactory understanding of English/national language of host country, in order to give fully informed consent. * Either suffering with depressive symptoms currently, or who have at least one risk factor for antenatal depression. * Owning a smartphone capable of downloading and running HappyMums application Exclusion Criteria: * Inability to give informed consent.
Where this trial is running
Zagreb and 6 other locations
- Catholic University of Croatia — Zagreb, Croatia (Recruiting)
- University of Helsinki — Helsinki, Finland (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- San Raffaele Hospital — Milan, Italy (Recruiting)
- University of Milan — Milan, Italy (Recruiting)
- SWPS University — Warsaw, Poland (Recruiting)
- King's College London — London, UK, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Anthony J Woods, PhD
- Email: tony.woods@kcl.ac.uk
- Phone: +44 7720884604
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.