PregnancyHappyMumsNCT06578845
HappyMums Mobile Application Study
An observational study of Pregnancy and Antenatal Depression, run by King's College London at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Antenatal Depression
- How many people
- 1,000 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 18 Feb 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Italy2 sites, 2 recruiting
- Recruiting
San Raffaele Hospital
Milan
- Recruiting
University of Milan
Milan
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, UK, SE5 9RX
Riddhi Laijawala, 07796633462, riddhi.laijawala@kcl.ac.uk
Anthony Woods, PhD, tony.woods@kcl.ac.uk
About this study
Official title: 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?
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.
Read the detailed description
HappyMums aims to develop a digital platform (smartphone app), and investigate whether data collected by a mobile app can be used to help learn more about mental health symptoms in pregnant women and birthing people at risk of depression in pregnancy.
This study aims to investigate the acceptability and usability of the HappyMums App. Following data collection, data will be aggregated to generate statistical models, with the aim of testing their predictive ability for antenatal depression trajectories.
The application will collect and integrate heterogenous data and will also allow an improvement of lifestyle attitudes, the maintenance of wellbeing in pregnancy, and the continuous monitoring of treatment efficacy. HM will therefore contribute to reducing the stigma by empowering mothers and birthing parents to monitor and master their mental health.
The study objective is to actively and passively gather data relevant to perinatal mental health, via a mobile application, which will be used to retrospectively develop an algorithm capable of identifying mental health trajectories in at-risk women/birthing people. The app will include game-like activities, access to an antenatal wellbeing course and space for pregnancy- and health-related data logging and monitoring. It will also utilise smartphone sensors to collect passive data types such as GPS, phone usage and step counts. This study will test the use of such mobile applications for patient mental health monitoring, and will also collect traditional research data such as biological samples and standardised questionnaires to be used as comparators to app-derived data.
Participants: Participants will be pregnant people either currently experiencing depressive symptoms, or who meet criteria for at least one risk factor for antenatal depression, previously identified from the literature, such as pregnancy complications or lack of social support. They will be recruited from 13 weeks' gestation to 28 weeks' gestation.
Recruitment: Recruitment will be conducted through self-referral, social media and online advertisement, and poster/flyer advertising in spaces and publications relevant to pregnant people, such as antenatal and health clinics, antenatal education spaces, children and family centres and newsletters.
Measures and Outcomes: Models will be generated to determine the ability of passively and actively app-collected data to predict antenatal depression symptoms through pregnancy, and how this compares to traditional measures such as standardised mental health questionnaires: Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Assessment (GAD-7) and Patient Health Questionnaire (PHQ-9).
For further cohort characterisation and to determine the influence of risk factors, other measures will also be collected and tested in the model: Mini International Neuropsychiatric Interview (subset only), Childhood Trauma Questionnaire (subset only), Adult Attachment Questionnaire, Life Events, Composite Abuse Scale, Maternal Antenatal Attachment Scale (subset only), Perceived Stress Scale (subset only), Multidimensional Scale of Perceived Social Support (subset only), Couple Satisfaction Index (subset only) and Postpartum Bonding Questionnaire (subset only).
- Conditions
- Pregnancy, Antenatal Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to end of pregnancy.
Secondary outcomes (4)
Usability of the mobile application - System Usability Scale
Questionnaire given to participants after pregnancy to ascertain if they find the app system usable.
Measured: 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.
Questionnaire given to participants after pregnancy to ascertain if they find the app system acceptable.
Measured: Administered once - to be completed from delivery to 2 months postpartum.
Severity of antenatal depression - Edinburgh Postnatal Depression Scale
Antenatal depression will be measured using the EPDS, and will be available to complete on the application every 2 weeks.
Measured: Every 2 weeks from enrolment to end of pregnancy.
Development of clinically significant depression - Mini International Neuropsychiatric Interview
The MINI will be administered to a validation sub-cohort to identify development of, or change in, symptoms of Major Depressive Disorder. This will be used to validate app-derived data types used to identify depression.
Measured: Administered at enrolment and up to 2 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start18 Feb 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Ospedale San Raffaele, Catholic University of Croatia, University of Helsinki, Charite University, Berlin, Germany, SWPS University of Social Sciences and Humanities, Ab.Acus, University of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578845
- Sponsor's protocol ID
- KCL IRAS 339391
- Acronym
- HappyMums
- Status last verified
- Nov 2025
- First submitted
- 28 May 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41638734
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT06578845
- Acronym / sponsor ID
- HappyMums / KCL IRAS 339391
- Conditions
- Pregnancy, Antenatal Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Milan, Ospedale San Raffaele, Catholic University of Croatia, University of Helsinki, Charite University, Berlin, Germany, SWPS University of Social Sciences and Humanities, Ab.Acus, University of Barcelona
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HappyMums aims to develop a digital platform (smartphone app), and investigate whether data collected by a mobile app can be used to help learn more about mental health symptoms in pregnant women and birthing people at risk of depression in pregnancy.
This study aims to investigate the acceptability and usability of the HappyMums App. Following data collection, data will be aggregated to generate statistical models, with the aim of testing their predictive ability for antenatal depression trajectories.
The application will collect and integrate heterogenous data and will also allow an improvement of lifestyle attitudes, the maintenance of wellbeing in pregnancy, and the continuous monitoring of treatment efficacy. HM will therefore contribute to reducing the stigma by empowering mothers and birthing parents to monitor and master their mental health.
The study objective is to actively and passively gather data relevant to perinatal mental health, via a mobile application, which will be used to retrospectively develop an algorithm capable of identifying mental health trajectories in at-risk women/birthing people. The app will include game-like activities, access to an antenatal wellbeing course and space for pregnancy- and health-related data logging and monitoring. It will also utilise smartphone sensors to collect passive data types such as GPS, phone usage and step counts. This study will test the use of such mobile applications for patient mental health monitoring, and will also collect traditional research data such as biological samples and standardised questionnaires to be used as comparators to app-derived data.
Participants: Participants will be pregnant people either currently experiencing depressive symptoms, or who meet criteria for at least one risk factor for antenatal depression, previously identified from the literature, such as pregnancy complications or lack of social support. They will be recruited from 13 weeks' gestation to 28 weeks' gestation.
Recruitment: Recruitment will be conducted through self-referral, social media and online advertisement, and poster/flyer advertising in spaces and publications relevant to pregnant people, such as antenatal and health clinics, antenatal education spaces, children and family centres and newsletters.
Measures and Outcomes: Models will be generated to determine the ability of passively and actively app-collected data to predict antenatal depression symptoms through pregnancy, and how this compares to traditional measures such as standardised mental health questionnaires: Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Assessment (GAD-7) and Patient Health Questionnaire (PHQ-9).
For further cohort characterisation and to determine the influence of risk factors, other measures will also be collected and tested in the model: Mini International Neuropsychiatric Interview (subset only), Childhood Trauma Questionnaire (subset only), Adult Attachment Questionnaire, Life Events, Composite Abuse Scale, Maternal Antenatal Attachment Scale (subset only), Perceived Stress Scale (subset only), Multidimensional Scale of Perceived Social Support (subset only), Couple Satisfaction Index (subset only) and Postpartum Bonding Questionnaire (subset only).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants who continue to use mobile application from enrolment until they give birth.
Time frame: From enrolment to end of pregnancy.
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.
4 secondary outcomes
Usability of the mobile application - System Usability Scale
Time frame: 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.
Time frame: Administered once - to be completed from delivery to 2 months postpartum.
Severity of antenatal depression - Edinburgh Postnatal Depression Scale
Time frame: Every 2 weeks from enrolment to end of pregnancy.
Development of clinically significant depression - Mini International Neuropsychiatric Interview
Time frame: Administered at enrolment and up to 2 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 41638734Priestley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Antenatal Depression, run by King's College London at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Croatia, Finland, Germany, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony J Woods, PhD (+44 7720884604, tony.woods@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who continue to use mobile application from enrolment until they give birth. (time frame: From enrolment to end of pregnancy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06578845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.