Biometrics in Longitudinal Uptake for Early Monitoring and Assessing Perinatal Patterns of Emotions in Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Wearable device adherence completion rate
研究概览
简要总结
The goal of this feasibility study is to learn whether wearable devices and self-report surveys can help researchers better understand changes in mood during pregnancy and after birth in young pregnant individuals with a history of major depressive disorder. The study will also examine whether this type of monitoring is practical and acceptable for participants and clinicians. The main questions it aims to answer are:
- Can researchers successfully collect wearable and survey data throughout late pregnancy and the first 3 months after birth?
- Do participants and clinicians find wearable-based monitoring easy to use and helpful?
- Are changes in sleep, heart rate, activity, and other wearable data linked to mood changes during the perinatal period?
Researchers will compare 2 wearable devices, the Oura Ring and EmbracePlus, to see which device provides more complete and usable data.
Participants will:
- Wear either the Oura Ring or EmbracePlus device every day from the third trimester of pregnancy until 3 months after birth
- Complete short daily and biweekly questionnaires about mood and wellbeing
- Allow the wearable device to collect information such as sleep, heart rate, heart rate variability, and physical activity
The study will include 10 participants. Researchers will measure feasibility by looking at how many participants join the study and how much study data is completed. The study team hopes at least 70% of scheduled study activities data will be collected.
Researchers will also interview 5 participants and 4 reproductive psychiatry clinicians about their experiences using wearable monitoring. These interviews will explore ease of use, usefulness in clinical care, and how wearable data may fit into electronic medical records.
This study may help researchers develop future tools that can predict the risk of perinatal depression earlier and support more personalized care during pregnancy and after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 16 years
- •Pregnant, 13-27 weeks gestation at enrollment
- •Previous diagnosis of major depressive disorder (MDD), confirmed by Mini International Neuropsychiatric Interview (MINI) (not necessarily perinatal onset)
- •Currently in remission (EPDS score < 9)
- •Access to a smartphone and internet, or willingness to use a study-provided device
排除标准
- •Active alcohol or substance use disorder within the past 12 months
- •Active suicidal ideation
- •History of bipolar disorder or primary psychotic disorder
- •Physical condition preventing use of Oura Ring or EmbracePlus (expected to be rare)
研究组 & 干预措施
Oura Ring
Participants randomized to this arm will wear the Oura Ring continuously from the third trimester of pregnancy through three months postpartum. The device will collect sleep, activity, heart rate, and heart rate variability data passively, alongside daily and biweekly self-report measures.
干预措施: Oura Ring (Photoplethysmography-based wearable ring) (Device)
EmbracePlus
Participants randomized to this arm will wear the EmbracePlus smartwatch continuously from the third trimester of pregnancy through three months postpartum. The device will collect sleep, activity, heart rate, heart rate variability, and electrodermal activity data passively, alongside daily and biweekly self-report measures.
干预措施: EmbracePlus Watch (Electrodermal activity wristband sensor) (Device)
结局指标
主要结局
Wearable device adherence completion rate
时间窗: From enrollment (13-27 weeks gestation) through 3 months postpartum
Feasibility of continuous wearable device data collection will be assessed by the proportion of scheduled data points completed during continuous daily wear. Wearable use profiles will be categorized as low, moderate, or high based on continuous daily wear without interruptions of more than 3 hours. Feasibility will be established if ≥ 70% of scheduled data points are completed across the study period.
Daily Visual Analogue Scale mood entry completion rate
时间窗: From enrollment (13-27 weeks gestation) through 3 months postpartum
Feasibility of daily mood self-reporting will be assessed by the proportion of scheduled Visual Analogue Scale mood entries completed by participants. The Visual Analogue Scale is a 100-point scale (range: 0-100), where higher scores indicate better mood. Feasibility will be established if ≥ 70% of scheduled entries are completed across the study period.
Edinburgh Postnatal Depression Scale completion rate
时间窗: From enrollment (13-27 weeks gestation) through 3 months postpartum
Feasibility of biweekly depression screening will be assessed by the proportion of scheduled Edinburgh Postnatal Depression Scale surveys completed. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item questionnaire (range: 0-30), where higher scores indicate greater severity of depressive symptoms. Feasibility will be established if ≥ 70% of scheduled surveys are completed across the study period.
Generalized Anxiety Disorder-7 completion rate
时间窗: From enrollment (13-27 weeks gestation) through 3 months postpartum
Feasibility of biweekly anxiety screening will be assessed by the proportion of scheduled Generalized Anxiety Disorder-7 surveys completed. The Generalized Anxiety Disorder-7 is a 7-item questionnaire (range: 0-21), where higher scores indicate greater severity of anxiety symptoms. Feasibility will be established if ≥ 70% of scheduled surveys are completed across the study period.
次要结局
- Wearable device acceptability among participants (quantitative)(At 3 months postpartum (end of study))
- Wearable device acceptability among participants (qualitative)(At 3 months postpartum (end of study))
- Wearable device usability among participants(At 3 months postpartum (end of study))
- Wearable device acceptability and integration from the clinician perspective(Throughout the study period, up to 3 months postpartum)
- Participant recruitment(up to 56 weeks from the recruitment start date)
- Participant retention(From enrollment (13-27 weeks gestation) through 3 months postpartum)