Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578845
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-28
Brief Title:
HappyMums App Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to investigate whether pregnant people at risk of or currently suffering from antenatal depression find it acceptable and feasible 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
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 feasibility study aims to investigate the feasibility 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 womenbirthing 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 feasibility of 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 posterflyer 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
This feasibility study aims to investigate the feasibility 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 womenbirthing 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 feasibility of 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 posterflyer 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None