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Recruiting Observational

HappyMums Mobile Application Study

NCT06578845 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-02-18
Last updated
2025-12-09

Condition(s) studied

PregnancyAntenatal Depression

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Proportion of participants who continue to use mobile application from enrolment until they give birth. — 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.

Trial sites (7)

FacilityCityRegionStatus
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 Recruiting

More King's College London trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06578845 on ClinicalTrials.gov ↗ ← All trials in Italy