HappyMums Mobile Application Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorKing's College London
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability to give informed consent.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Pregnant people currently experiencing, or at risk of, antenatal depression
Trial outcomes
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.
Time frame
From enrolment to end of pregnancy.Secondary outcomes
1
Usability of the mobile application - System Usability Scale
Questionnaire given to participants after pregnancy to ascertain if they find the app system usable.
Time frame
Administered once - to be completed from delivery to 2 months postpartum.2
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.
Time frame
Administered once - to be completed from delivery to 2 months postpartum.3
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.
Time frame
Every 2 weeks from enrolment to end of pregnancy.4
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.
Time frame
Administered at enrolment and up to 2 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
University of Milan
Collaborator
Ospedale San Raffaele
Collaborator
Catholic University of Croatia
Collaborator
University of Helsinki
Collaborator
Charite University, Berlin, Germany
Collaborator
SWPS University of Social Sciences and Humanities
Collaborator
Ab.Acus
Collaborator
University of Barcelona
Collaborator
Source ClinicalTrials.gov