Wearable Technology for Postpartum Depression

(BLUESMAPPED Trial)

BB
Overseen ByBlanca Bolea-Alamanac, MD PhD
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Women's College Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am at least 16 years old.
I am currently 13 to 27 weeks pregnant.
I am currently in remission with a low depression score.
See 2 more

Exclusion Criteria

Physical condition preventing use of Oura Ring or EmbracePlus (expected to be rare)
Active alcohol or substance use disorder within the past 12 months
Active suicidal ideation
See 1 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Oura RingExperimental Treatment1 Intervention
Group II: EmbracePlusActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials
108
Recruited
43,700+

Canada Foundation for Innovation

Collaborator

Trials
9
Recruited
8,500+

University of Toronto

Collaborator

Trials
739
Recruited
1,125,000+