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?

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Antenatal Depression

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Carmine M Pariante, MD, PhD; Phone Number: +44 20 7848 5450; Email: carmine.pariante@kcl.ac.uk
• Study Contact Backup: Name: Anthony J Woods, PhD; Phone Number: +44 7720884604; Email: tony.woods@kcl.ac.uk

Study Locations

• Croatia
  • Zagreb, Croatia
    • Recruiting
    • Catholic University of Croatia
• Finland
  • Helsinki, Finland
    • Recruiting
    • University of Helsinki
• Germany
  • Berlin, Germany
    • Recruiting
    • Charité - Universitätsmedizin Berlin
• Italy
  • Milan, Italy
    • Recruiting
    • San Raffaele Hospital
  • Milan, Italy
    • Recruiting
    • University of Milan
• Poland
  • Warsaw, Poland
    • Recruiting
    • SWPS University
• United Kingdom
  • UK
    • London, UK, United Kingdom, SE5 9RX
      • Recruiting
      • King's College London
      • Contact: Riddhi Laijawala; Phone Number: 07796633462; Email: riddhi.laijawala@kcl.ac.uk
      • Contact: Anthony Woods, PhD; Email: tony.woods@kcl.ac.uk
      • Principal Investigator: Carmine Pariante, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the mobile application - System Usability Scale	Questionnaire given to participants after pregnancy to ascertain if they find the app system usable.	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.	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.	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.	Administered at enrolment and up to 2 months postpartum

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Charite University, Berlin, Germany; University of Helsinki; Ospedale San Raffaele; University of Milan; University of Barcelona; Ab.Acus; Catholic University of Croatia; SWPS University of Social Sciences and Humanities

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: KCL IRAS 339391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No