Early Detection of Perinatal Depression With Wearable Technology (BLUESMAPPED)

Biometrics in Longitudinal Uptake for Early Monitoring and Assessing Perinatal Patterns of Emotions in Depression

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Depression
• Intervention / Treatment: Device: Oura Ring (Photoplethysmography-based wearable ring); Device: EmbracePlus Watch (Electrodermal activity wristband sensor)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blanca Bolea-Alamanac, MD PhD; Phone Number: 4221 416-323-6400; Email: blanca.boleaalamanac@wchospital.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
      • Contact: Blanca M Bolea, MD PhD; Phone Number: 4221 416-323-6400; Email: Blanca.BoleaAlamanac@wchospital.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Oura 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.
Active Comparator: 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.	Device: EmbracePlus 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearable device adherence completion rate	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.	From enrollment (13-27 weeks gestation) through 3 months postpartum
Daily Visual Analogue Scale mood entry completion rate	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.	From enrollment (13-27 weeks gestation) through 3 months postpartum
Edinburgh Postnatal Depression Scale completion rate	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.	From enrollment (13-27 weeks gestation) through 3 months postpartum
Generalized Anxiety Disorder-7 completion rate	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.	From enrollment (13-27 weeks gestation) through 3 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearable device acceptability among participants (quantitative)	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)	At 3 months postpartum (end of study)
Wearable device acceptability among participants (qualitative)	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.	At 3 months postpartum (end of study)
Wearable device usability among participants	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).	At 3 months postpartum (end of study)
Wearable device acceptability and integration from the clinician perspective	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))	Throughout the study period, up to 3 months postpartum
Participant recruitment	Recruitment feasibility will be defined as successful enrollment of 10 eligible pregnant participants.	up to 56 weeks from the recruitment start date
Participant retention	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.	From enrollment (13-27 weeks gestation) through 3 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between sleep duration and depression symptom severity	Correlation between sleep duration (hours/night, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity and depression symptom severity	Correlation between physical activity (steps/day, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate and depression symptom severity	Correlation between resting heart rate (beats per minute, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability and depression symptom severity	Correlation between heart rate variability (RMSSD, ms, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity and daily mood	Correlation between physical activity (steps/day, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate and daily mood	Correlation between resting heart rate (beats per minute, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability and daily mood	Correlation between heart rate variability (RMSSD, ms, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).	From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data completeness between wearable devices	Comparison of data completeness (% of expected data points successfully recorded) between the two wearable devices across the study period.	From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data quality between wearable devices	Comparison of data quality (% of recorded data points meeting acceptable signal quality thresholds) between the two wearable devices across the study period.	From enrollment (13-27 weeks gestation) through 3 months postpartum

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: University of Toronto; Canada Foundation for Innovation

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Sleep; Risk Assessment; Depressive Disorder, Major; Perinatal Depression; Early Detection; Heart Rate; Ecological Momentary Assessment; Patient Acceptance of Health Care; Wearable Electronic Devices; Monitoring, Ambulatory; Depression, Postpartum; Passive Sensing
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Behavior; Treatment Adherence and Compliance; Health Behavior; Depressive Disorder, Major; Depression, Postpartum; Patient Acceptance of Health Care
• Other Study ID Numbers: 2025-0085-E; 12345 (Other Grant/Funding Number: Reasons for Hope Fund in Prevention and Early Detection of Mental Illness); 39923 (Other Grant/Funding Number: Canada Foundation for Innovation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small feasibility study enrolling 10 participants. Given the limited sample size, the sensitive nature of personal biometrics and questionnaire data, and the requirement to store data on hospital-based servers in accordance with national personal health information legislation, individual participant data will not be shared in order to protect participant confidentiality and privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No