Digital Interventions to Understand and Mitigate Stress Response

• ClinicalTrials.gov Identifier: NCT05923398
• Recruitment Status: Completed
• First Posted: June 28, 2023
• Last Update Posted: February 14, 2024
• Sponsor: Unity Health Toronto
• Collaborators: Toronto Metropolitan University; University of Toronto; University of Ontario Institute of Technology; Boston University; University of Ottawa; Western University, Canada; Centre for Addiction and Mental Health
• Information provided by (Responsible Party): Unity Health Toronto

Tracking Information

• First Submitted Date: December 20, 2022
• First Posted Date: June 28, 2023
• Last Update Posted Date: February 14, 2024
• Actual Study Start Date: May 1, 2023
• Actual Primary Completion Date: December 8, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2023)

• Subjective Units of Distress Scale (SUDS) [ Time Frame: Approximately 3.5 months ]
  The primary outcome will be the change in SUDS scores from (1) beginning to end of VR and (2) baseline to end of follow-up. The SUDS is an instrument (visualized as a fear thermometer) that ranges from scores of 0 to 100. It measures the intensity of emotions and other internal experiences, such as anxiety, anger, agitation, tension, and other painful emotions. Participants will complete SUDS before the VR scenario starts and once the VR scenario is over. Additionally, participants will complete the SUDS for a total of 8 times when in the VR scenario. Participants will also answer the SUDS using the web-based platform every week on Mondays, Thursdays, and Saturdays for approximately 3.5 months.
• Moral Injury Outcome Scale (MIOS-4; 4 item scale) [ Time Frame: Approximately 3.5 months ]
  The primary outcome will be the change in MIOS-4 scores from (1) beginning to end of VR and (2) baseline to end of follow-up. MIOS-4 is a short version of the MIOS-14. The 4 items have scores that range 0 (strongly disagree) to 4 (strongly agree); Total score ranges from 0 - 16. The MIOS is intended to measure the severity of moral injury outcomes as a result of a potentially morally damaging experience. Participants will complete the MIOS-4 during the VR scenario for a total of 8 times. Additionally, participants will answer the MIOS-4 using the web-based platform every week on Mondays and Thursdays for approximately 3.5 months.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 19, 2023)

• UCLA Loneliness Scale (3 item scale) [ Time Frame: Approximately 3.5 months ]
  This secondary outcome will be the change in UCLA scores from baseline to end of follow-up. Short, 3-item scale. Item's scores range from 1 (hardly ever) to 3 (often) and total score ranges from 3 to 9. Higher scores indicate more severe loneliness symptoms. Participants will answer the UCLA-3 using the web-based platform every week on Mondays and Thursdays for approximately 3.5 months.
• Generalized Anxiety Disorder Scale (GAD-7; 7 item scale) [ Time Frame: Approximately 3.5 months ]
  This secondary outcome will be the change in GAD-7 scores from baseline to end of follow-up. The GAD-7 is a 7-item scale with each item's score ranging from 0 (not at all) to 3 (nearly everyday). Total score ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms. Participants will answer the GAD-7 using the web-based platform every week on Saturdays for approximately 3.5 months.
• Generalized Anxiety Disorder Scale (GAD-2; 2 item scale) [ Time Frame: Approximately 3.5 months ]
  This secondary outcome will be the change in GAD-2 scores from baseline to end of follow-up. The GAD-2 only includes items 1 and 2 of the GAD-7. Each item's score ranges from 0 (not at all) to 3 (nearly everyday). Total score ranges from 0 to 6. Participants will answer the GAD-2 using the web-based platform every week on Mondays and Thursdays for approximately 3.5 months.
• Patient Health Questionnaire (PHQ-9; 9 item scale) [ Time Frame: Approximately 3.5 months ]
  This secondary outcome will be the change in PHQ-9 scores from baseline to end of follow-up. The PHQ-9 is a 9-item scale with each item's score ranging from 0 (not at all) to 3 (nearly every day). Total score ranges from 0 to 27. Higher scores indicate more severe depression symptoms. Participants will answer the PHQ-9 on Saturdays for approximately 3.5 months.
• Patient Health Questionnaire (PHQ-2; 2 item scale) [ Time Frame: Approximately 3.5 months ]
  This secondary outcome will be the change in PHQ-2 scores from baseline to end of follow-up. The PHQ-2 only includes items 1 and 2 of the GAD-9. Each item's score ranging from 0 (not at all) to 3 (nearly every day). Total score ranges from 0 to 6. Participants will answer the PHQ-2 using the web-based platform every week on Mondays and Thursdays for approximately 3.5 months.
• Moral Injury Outcome Scale (MIOS-14; 22 item scale) [ Time Frame: Approximately 3.5 months ]
  The primary outcome will be the change in MIOS-14 scores from (1) beginning to end of VR and (2) baseline to end of follow-up. MIOS-14 is a 22 item scale. Scores on the first 14 items range from 0 (strongly disagree) to 4 (strongly agree); total score ranges from 0 to 56. The other 8 items have scores that range from 0 (not at all) to 6 (extremely); total score ranges from 0 to 48. Participants will complete the MIOS-14 before the VR scenario starts and once the VR scenario is over. Additionally, participants will complete the MIOS-14 every Saturday for approximately 3.5 months.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Digital Interventions to Understand and Mitigate Stress Response
• Official Title: Digital Interventions to Understand and Mitigate Stress Response: Process & Content Evaluation to Move From Feasibility (SRL-4) to Simulated Demonstration (SRL-6)
• Brief Summary: Stress, anxiety, distress, and burnout are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. The understanding of factors underlying distress and resilience in complex workplace contexts is limited, and there are limited evidence-based interventions for stress and moral distress among frontline healthcare workers. The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality [VR], a web-based platform, and a wearable [Oura Ring]) to understand and reduce the experience of stress/distress faced by nursing professionals.
• Detailed Description: The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality [VR], a web-based platform, and a wearable [Oura Ring]) to understand and reduce the experience of stress/distress faced by nursing professionals. This study involves participation in an in-person VR setup and the use of an app and a wearable device over the duration of the study (14+ weeks). The immersive VR component of the study involves a virtual experience of navigating a challenging workplace scenario to understand stress response and provide an overview of interventions that can be used to reduce workplace stress. Upon completion of the in-person VR visit, participants will continue to use the app and the wearable for the study duration to understand stress responses in their actual workplaces. Participants will have real-time access to their essential data on wellness collected through the app and wearable (e.g., sleep, activity, physiological signals, anxiety symptoms). The Digital Intervention Suite (combined use of these three components: VR, app, and wearable) is essential for a thorough understanding of stress and moral distress. This is a de-identified study, and the team will only have access to de-identified data for analysis at the end of the study.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Over approximately 3.5 months, each nursing professional will participate in the following:

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.

Masking: None (Open Label)
Primary Purpose: Other

Condition

• Distress, Emotional
• Stress Response Among Nursing Professionals During the COVID-19
• Stress Reaction; Acute

Intervention

Behavioral: 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.

Study Arms

Experimental: 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).

Intervention: Behavioral: Digital Intervention Group

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 19, 2023): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 8, 2023
• Actual Primary Completion Date: December 8, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario.
2. Ownership of a smartphone.

Exclusion criteria:

1. History of seizures (except febrile seizure).
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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT05923398
• Other Study ID Numbers: 22-279
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Unity Health Toronto
• Original Responsible Party: Same as current
• Current Study Sponsor: Unity Health Toronto
• Original Study Sponsor: Same as current

Collaborators

• Toronto Metropolitan University
• University of Toronto
• University of Ontario Institute of Technology
• Boston University
• University of Ottawa
• Western University, Canada
• Centre for Addiction and Mental Health

Investigators

• Principal Investigator: Venkat Bhat, MD MSc; Unity Health Toronto

• PRS Account: Unity Health Toronto
• Verification Date: February 2024