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?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Proportion of participants who continue to use mobile application from enrolment until they give birth.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Inability to give informed consent.
结局指标
主要结局
Proportion of participants who continue to use mobile application from enrolment until they give birth.
时间窗: 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.
次要结局
- Severity of antenatal depression - Edinburgh Postnatal Depression Scale(Every 2 weeks from enrolment to end of pregnancy.)
- Development of clinically significant depression - Mini International Neuropsychiatric Interview(Administered at enrolment and up to 2 months postpartum)
- Usability of the mobile application - System Usability Scale(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.(Administered once - to be completed from delivery to 2 months postpartum.)