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HappyMums Mobile Application Study

Sponsor: King's College London

NCT ID: NCT06578845

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 20 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study tests a phone app called HappyMums for pregnant people who have symptoms of depression during pregnancy (known as antenatal depression) or who have at least one risk factor for it. The study is run by King's College London. Taking part involves using the app on your own smartphone.

Who can take part

  • You are pregnant, aged 18 or over, and up to 28 weeks into your pregnancy.
  • You understand English (or the main language of the country running the study) well enough to give informed consent. Informed consent means fully understanding the study and agreeing to take part.
  • You have symptoms of depression now, or you have at least one risk factor (something that makes depression during pregnancy more likely).
  • You own a smartphone that can download and run the HappyMums app.

Who may not be able to

  • You cannot give informed consent (you cannot fully understand the study and agree to take part).

What taking part involves

  • • Downloading and using the HappyMums app on your own smartphone.
  • • What the app asks you to do, and how long you use it: Not stated — ask the trial team.

Time commitment: How long the study lasts and whether there are any clinic visits: Not stated — ask the trial team; taking part involves using the HappyMums app on your own smartphone.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
Female
Number of participants
1,000
Started
2025-02-18
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for pregnancy
  • • Clinical study - 1,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with pregnancy
  • • Female only

Where?

  • • London - King's College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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).

PregnancyAntenatal Depression

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓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 agreement to take part.
  • ✓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 take part

  • ✗Inability to give agreement to take part.
See the full 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 Is This Study? (1 UK site)

King's College London

London SE5 9RX, United Kingdom

Recruiting
Site contact (verified)
Carmine Pariante, ProfessorPrincipal Investigator
Anthony Woods, PhDtony.woods@kcl.ac.uk

How to Get in Touch

Anthony J Woods, PhD

Sponsor contact

CONTACT

+44 7720884604 tony.woods@kcl.ac.uk

Carmine M Pariante, MD, PhD

Sponsor contact

CONTACT

+44 20 7848 5450 carmine.pariante@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-11