Early Detection of Perinatal Depression With Wearable Technology (NCT07784244)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (5 items).
Location: Women's College Hospital — Toronto, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Women's College Hospital — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.