Wearable Technology for Postpartum Depression
(BLUESMAPPED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women's College Hospital
Lead Sponsor
Canada Foundation for Innovation
Collaborator
University of Toronto
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.