Perinatal Depression
Conditions
Keywords
Pregnancy, Ecological Momentary Assessment, Monitoring, Ambulatory, Depression, Postpartum, Wearable Electronic Devices, Heart Rate, Risk Assessment, Patient Acceptance of Health Care, Passive Sensing, Early Detection, Sleep, Depressive Disorder, Major, Perinatal Depression
Brief summary
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.
Interventions
DEVICEOura Ring (Photoplethysmography-based wearable ring)
A lightweight titanium ring worn continuously on the index finger that passively collects sleep, physical activity, heart rate, and heart rate variability data via infrared optical sensors and a 3D accelerometer. Worn throughout the third trimester of pregnancy and three months postpartum to monitor physiological parameters associated with perinatal depression risk.
DEVICEEmbracePlus Watch (Electrodermal activity wristband sensor)
A medical-grade waterproof smartwatch worn continuously on the wrist that passively collects sleep, physical activity, heart rate, heart rate variability, and electrodermal activity data via photoplethysmography and ventral electrodermal sensors. Worn throughout the third trimester of pregnancy and three months postpartum to monitor physiological parameters associated with perinatal depression risk.
Sponsors
Women's College Hospital
Canada Foundation for Innovation
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearable device adherence completion rate | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wearable device acceptability among participants (quantitative) | At 3 months postpartum (end of study) | Acceptability of the wearable device will be assessed through a questionnaire administered to participants at study completion. Questions will evaluate comfort, ease of use, perceived burden, satisfaction with the device, and willingness to continue use in a larger study. All questions will be rated from 0-5 (0 being strongly disagree, 3 being neutral, 5 being strongly agree) |
| Wearable device acceptability among participants (qualitative) | At 3 months postpartum (end of study) | Acceptability the wearable device will be assessed through semi-structured interviews administered to participants at study completion. Questions will evaluate comfort, ease of use, perceived burden, satisfaction with the device, and willingness to continue use in a larger study using thematic analysis. |
| Wearable device usability among participants | At 3 months postpartum (end of study) | Usability of the wearable device will be assessed through the System Usability Scale (SUS) administered to participants at study completion. Questions will evaluate comfort and ease of use the device on a 5 point scale (0- strongly disagree, 3- neutral, 5-strongly agree). |
| Wearable device acceptability and integration from the clinician perspective | Throughout the study period, up to 3 months postpartum | Clinician acceptability will be assessed through questionnaires and interviews conducted during the study period, evaluating views on wearable technology, potential integration of device-derived data into electronic medical records, and feasibility of incorporating wearable monitoring into routine perinatal care workflows. (Usability of the device will be rated on a likert scale: Strongly disagree (1) to Strongly agree (5)) |
| Participant recruitment | up to 56 weeks from the recruitment start date | Recruitment feasibility will be defined as successful enrollment of 10 eligible pregnant participants. |
| Participant retention | From enrollment (13-27 weeks gestation) through 3 months postpartum | Retention will be considered successful if ≥ 80% of enrolled participants complete follow-up through 3 months postpartum. Reasons for dropout or discontinuation will be recorded. |
Countries
Canada
Contacts
CONTACTBlanca Bolea-Alamanac, MD PhD
Outcome results
None listed