Perinatal DepressionBLUESMAPPEDNCT07784244
Early Detection of Perinatal Depression With Wearable Technology
A study testing Oura Ring (Photoplethysmography-based wearable ring) and EmbracePlus Watch (Electrodermal activity wristband sensor) in people with Perinatal Depression, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Oura Ring (Photoplethysmography-based wearable ring) and EmbracePlus Watch (Electrodermal activity wristband sensor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Women's College Hospital
Toronto, Ontario, M5S 1B2
Blanca M Bolea, MD PhD, 416-323-6400 ext. 4221, Blanca.BoleaAlamanac@wchospital.ca
About this study
Official title: 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?
Read more
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
- Being tested
- Oura Ring (Photoplethysmography-based wearable ring), EmbracePlus Watch (Electrodermal activity wristband sensor)
- 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
- Medical subject headings
- Depression, Postpartum, Patient Acceptance of Health Care, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EmbracePlus Watch (Electrodermal activity wristband sensor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment (13-27 weeks gestation) through 3 months postpartum
Secondary outcomes (6)
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)
Measured: 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.
Measured: 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).
Measured: 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))
Measured: Throughout the study period, up to 3 months postpartum
Participant recruitment
Recruitment feasibility will be defined as successful enrollment of 10 eligible pregnant participants.
Measured: 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.
Measured: From enrollment (13-27 weeks gestation) through 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canada Foundation for Innovation, University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784244
- Sponsor's protocol ID
- 2025-0085-E
- Other IDs
- 12345, 39923
- Acronym
- BLUESMAPPED
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biometrics in Longitudinal Uptake for Early Monitoring and Assessing Perinatal Patterns of Emotions in Depression
- ClinicalTrials.gov ID
- NCT07784244
- Acronym / sponsor ID
- BLUESMAPPED / 2025-0085-E
- Conditions
- Perinatal Depression
- Keywords
- Pregnancy, Ecological Momentary Assessment, Monitoring, Ambulatory, Depression, Postpartum, Wearable Electronic Devices, Heart Rate, Risk Assessment, Patient Acceptance of Health Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canada Foundation for Innovation, University of Toronto
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oura Ring | Experimental | Device: Oura Ring (Photoplethysmography-based wearable 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. |
| EmbracePlus | Active comparator | Device: EmbracePlus Watch (Electrodermal activity wristband sensor)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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Oura Ring |
| 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. | Device | EmbracePlus |
Primary outcome
Wearable device adherence completion rate
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
Daily Visual Analogue Scale mood entry completion rate
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
Edinburgh Postnatal Depression Scale completion rate
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
Generalized Anxiety Disorder-7 completion rate
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
6 secondary outcomes
Wearable device acceptability among participants (quantitative)
Time frame: At 3 months postpartum (end of study)
Wearable device acceptability among participants (qualitative)
Time frame: At 3 months postpartum (end of study)
Wearable device usability among participants
Time frame: At 3 months postpartum (end of study)
Wearable device acceptability and integration from the clinician perspective
Time frame: Throughout the study period, up to 3 months postpartum
Participant recruitment
Time frame: up to 56 weeks from the recruitment start date
Participant retention
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oura Ring (Photoplethysmography-based wearable ring) and EmbracePlus Watch (Electrodermal activity wristband sensor) in people with Perinatal Depression, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blanca Bolea-Alamanac, MD PhD (416-323-6400 ext. 4221, blanca.boleaalamanac@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearable device adherence completion rate (time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.