Digital Interventions to Understand and Mitigate Stress Response
NCT ID: NCT05923398
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2023-05-01
2023-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
A) Undergo a virtual reality scenario to understand and reduce stress and moral distress related to difficult decision-making in complex moral situations during the COVID-19 pandemic.
B) Use a web-based platform to measure stress, moral distress, and other mental health symptoms, as well as a commercial wearable device to collect physiological, sleep, and activity data to understand and examine the contribution of active and passive data to stress and moral distress.
During analysis, once all passive and active data is collected we will create a personal digital phenotype profile (pDPP) based on the physiological data collected during a morally challenging situation in a virtual environment as well as the wearable and web-based data to help understand stress and moral distress at the individual level.
OTHER
NONE
Study Groups
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Experimental Group
During the duration of the study, all participants will use the Digital Intervention Suite (a web-based component, a VR platform, and wearable device) to measure passive and active data, such as: psychological variables (e.g., moral distress, anxiety, and depression) and physiological variables (e.g., heart rate and sleep).
Digital Intervention Group
Participants will use a Digital Intervention Suite composed of a virtual reality (VR) scenario, a web-based platform, and a wearable device to assess their stress response in near-real time and in a hypothetical stressful scenario.
During the VR scenario, physiological signals such as Galvanic Skin Response (GSR), Electrocardiogram (ECG), Respiratory Independence (RI), and Photoplethysmography will be measured. Additionally, an educational intervention video on how to deal with stress and distress will be shown to participants. We will then request participants to practice the skills taught during the intervention video in the VR scenario.
The wearable device (Oura Ring) will measure sleep, activity, readiness information, heart rate, heart rate variability, body temperature (delta), and respiratory rate. Additionally, the web-based platform will, through questionnaires, assess stress-related symptoms such as loneliness, anxiety, depression, and moral injury.
Interventions
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Digital Intervention Group
Participants will use a Digital Intervention Suite composed of a virtual reality (VR) scenario, a web-based platform, and a wearable device to assess their stress response in near-real time and in a hypothetical stressful scenario.
During the VR scenario, physiological signals such as Galvanic Skin Response (GSR), Electrocardiogram (ECG), Respiratory Independence (RI), and Photoplethysmography will be measured. Additionally, an educational intervention video on how to deal with stress and distress will be shown to participants. We will then request participants to practice the skills taught during the intervention video in the VR scenario.
The wearable device (Oura Ring) will measure sleep, activity, readiness information, heart rate, heart rate variability, body temperature (delta), and respiratory rate. Additionally, the web-based platform will, through questionnaires, assess stress-related symptoms such as loneliness, anxiety, depression, and moral injury.
Eligibility Criteria
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Inclusion Criteria
2. Ownership of a smartphone.
Exclusion Criteria
2. Use of electronic medical devices (e.g., cardiac pacemakers, hearing aids, and defibrillators).
3. A score of ≥ 15 on the Generalized Anxiety Disorder (GAD-7) scale
4. A score of ≥ 20 on the Patient Health Questionnaire (PHQ-9).
18 Years
ALL
Yes
Sponsors
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Toronto Metropolitan University
OTHER
University of Toronto
OTHER
University of Ontario Institute of Technology
OTHER
Boston University
OTHER
University of Ottawa
OTHER
Western University, Canada
OTHER
Centre for Addiction and Mental Health
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Venkat Bhat, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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Martin J, Rueda A, Lee GH, Tassone VK, Park H, Ivanov M, Darnell BC, Beavers L, Campbell DM, Nguyen B, Torres A, Jung H, Lou W, Nazarov A, Ashbaugh A, Kapralos B, Litz B, Jetly R, Dubrowski A, Strudwick G, Krishnan S, Bhat V. Digital Interventions to Understand and Mitigate Stress Response: Protocol for Process and Content Evaluation of a Cohort Study. JMIR Res Protoc. 2024 May 6;13:e54180. doi: 10.2196/54180.
Other Identifiers
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22-279
Identifier Type: -
Identifier Source: org_study_id
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