Early Detection of Perinatal Depression With Wearable Technology

NCT07784244 | Not Yet Recruiting

• 3 other identifiers: 2025-0085-E1234539923
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Wearable device acceptability among participants (quantitative)

  At 3 months postpartum (end of study)

• Wearable device acceptability among participants (qualitative)

  At 3 months postpartum (end of study)

• Wearable device usability among participants

  At 3 months postpartum (end of study)

• Wearable device acceptability and integration from the clinician perspective

  Throughout the study period, up to 3 months postpartum

• Participant recruitment

  up to 56 weeks from the recruitment start date

Other Outcomes (9)

• Correlation between sleep duration and depression symptom severity

  From enrollment (13-27 weeks gestation) through 3 months postpartum

• Correlation between physical activity and depression symptom severity

  From enrollment (13-27 weeks gestation) through 3 months postpartum

• Correlation between heart rate and depression symptom severity

  From enrollment (13-27 weeks gestation) through 3 months postpartum

Study Arms (2)

Oura Ring

EXPERIMENTAL

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)

EmbracePlus

ACTIVE COMPARATOR

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)

Interventions

Oura Ring (Photoplethysmography-based wearable ring) DEVICE

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.

Oura Ring

EmbracePlus Watch (Electrodermal activity wristband sensor) DEVICE

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.

EmbracePlus

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Women's College Hospital: lead
• Canada Foundation for Innovation: collaborator
• University of Toronto: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum; Patient Acceptance of Health Care; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Blanca Bolea-Alamanac, MD PhD

CONTACT

416-323-6400; blanca.boleaalamanac@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)