HappyMums Mobile Application Study
HappyMums
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?
1 other identifier
observational
1,000
6 countries
7
Brief Summary
The goal of this study is to investigate whether pregnant people at risk of, or currently suffering from antenatal depression, find it acceptable to use the 'HappyMums' mobile application during their pregnancy. This app will collect data relevant to their mental health passively and through active engagement from the user. After the study is complete, these data will be put together to determine if such data types could be used in future to help predict and identify antenatal depression, and aid better treatment decisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
February 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
December 9, 2025
November 1, 2025
1.4 years
May 28, 2024
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants who continue to use mobile application from enrolment until they give birth.
The primary outcome is whether participants feel able to continue to use the app throughout their pregnancy. Usage data of the app will be logged to ascertain if participants continue to engage with it throughout their pregnancy. 'Usage' of the application will be defined as submission of any questionnaire, logging of data, or interaction with any other activities or content on the application. This will be quantified as proportion of participants who use the app weekly from their enrolment on the app to the end of their pregnancy.
From enrolment to end of pregnancy.
Secondary Outcomes (4)
Usability of the mobile application - System Usability Scale
Administered once - to be completed from delivery to 2 months postpartum.
Acceptance of the mobile application - Unified Theory of Acceptance and Use of Technology Scale.
Administered once - to be completed from delivery to 2 months postpartum.
Severity of antenatal depression - Edinburgh Postnatal Depression Scale
Every 2 weeks from enrolment to end of pregnancy.
Development of clinically significant depression - Mini International Neuropsychiatric Interview
Administered at enrolment and up to 2 months postpartum
Study Arms (1)
Pregnant people currently experiencing, or at risk of, antenatal depression
All eligible participants will be given access to the 'HappyMums' mobile application, which will be used to collect data pertinent to their mental health status during pregnancy.
Eligibility Criteria
The study will consist of pregnant participants, up to 28 weeks' gestation, who have at least one risk factor for antenatal depression, or current depressive symptoms.
You may qualify if:
- 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
You may not qualify if:
- Inability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- University of Milancollaborator
- Ospedale San Raffaelecollaborator
- Catholic University of Croatiacollaborator
- University of Helsinkicollaborator
- Charite University, Berlin, Germanycollaborator
- SWPS University of Social Sciences and Humanitiescollaborator
- Ab.Acuscollaborator
- University of Barcelonacollaborator
Study Sites (7)
Catholic University of Croatia
Zagreb, Croatia
University of Helsinki
Helsinki, Finland
Charité - Universitätsmedizin Berlin
Berlin, Germany
San Raffaele Hospital
Milan, Italy
University of Milan
Milan, Italy
SWPS University
Warsaw, Poland
King's College London
London, UK, SE5 9RX, United Kingdom
Related Publications (1)
Priestley K, Laijawala R, Hazelgrove K, Bind R, Rebecchini L, Mariani N, Alford S, Kirkpatrick M, Mancino F, Kim S, Pushpakanthan S, Biaggi A, Cavaliere L, Di Benedetto MG, Matijas M, Zutic M, Brekalo M, Nakic Rados S, Zukowska K, Braniecka A, Jackowska M, Bessi M, Agnoletto E, Melloni EMT, Benedetti F, Bulgheroni M, La Gamba M, Martin Isla C, Izquierdo Morcillo C, Lekadir K, Salo V, Seikku T, Raikkonen K, Godara M, Schneider-Schmid UM, Entringer S, Buss C, de Barra D, Woods A, Dazzan P, Cattaneo A, Pariante C. HappyMums mobile application study protocol: use of a smartphone application to gather data predictive of antenatal depression. BMJ Open. 2026 Feb 4;16(2):e106978. doi: 10.1136/bmjopen-2025-106978.
PMID: 41638734DERIVED
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
August 29, 2024
Study Start
February 18, 2025
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
December 9, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share