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Early Detection of Perinatal Depression With Wearable Technology (BLUESMAPPED)

21. August 2026 aktualisiert von: Women's College Hospital

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Machbarkeit des Geräts
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Aktiver Komparator: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Wearable device adherence completion rate
Zeitfenster: 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.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Daily Visual Analogue Scale mood entry completion rate
Zeitfenster: 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.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Edinburgh Postnatal Depression Scale completion rate
Zeitfenster: 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.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Generalized Anxiety Disorder-7 completion rate
Zeitfenster: 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.
From enrollment (13-27 weeks gestation) through 3 months postpartum

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Wearable device acceptability among participants (quantitative)
Zeitfenster: At 3 months postpartum (end of study)
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)
Zeitfenster: At 3 months postpartum (end of study)
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
Zeitfenster: At 3 months postpartum (end of study)
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
Zeitfenster: Throughout the study period, up to 3 months postpartum
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
Zeitfenster: up to 56 weeks from the recruitment start date
Recruitment feasibility will be defined as successful enrollment of 10 eligible pregnant participants.
up to 56 weeks from the recruitment start date
Participant retention
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation between sleep duration and depression symptom severity
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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
Zeitfenster: From enrollment (13-27 weeks gestation) through 3 months postpartum
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Women's College Hospital

Mitarbeiter

University of Toronto
Canada Foundation for Innovation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. November 2027

Studienabschluss (Geschätzt)

1. November 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. August 2026

Zuerst gepostet (Tatsächlich)

25. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-0085-E
  • 12345 (Andere Zuschuss-/Finanzierungsnummer: Reasons for Hope Fund in Prevention and Early Detection of Mental Illness)
  • 39923 (Andere Zuschuss-/Finanzierungsnummer: Canada Foundation for Innovation)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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