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Digital Interventions to Understand and Mitigate Stress Response

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Digital Intervention Group
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Distress, Emotional focused on measuring Moral distress, Stress, Virtual Reality, Wearables, Web-based intervention, Nursing professionals, Nursing staff, Distress, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario. Ownership of a smartphone. Exclusion criteria: History of seizures (except febrile seizure). Use of electronic medical devices (e.g., cardiac pacemakers, hearing aids, and defibrillators). A score of ≥ 15 on the Generalized Anxiety Disorder (GAD-7) scale A score of ≥ 20 on the Patient Health Questionnaire (PHQ-9).

Sites / Locations

  • St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

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).

Outcomes

Primary Outcome Measures

Subjective Units of Distress Scale (SUDS)
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)
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.

Secondary Outcome Measures

UCLA Loneliness Scale (3 item scale)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
December 20, 2022
Last Updated
June 19, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05923398
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Emotional, Stress Response Among Nursing Professionals During the COVID-19, Stress Reaction; Acute
Keywords
Moral distress, Stress, Virtual Reality, Wearables, Web-based intervention, Nursing professionals, Nursing staff, Distress, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Digital Intervention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective Units of Distress Scale (SUDS)
Description
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.
Time Frame
Approximately 3.5 months
Title
Moral Injury Outcome Scale (MIOS-4; 4 item scale)
Description
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.
Time Frame
Approximately 3.5 months
Secondary Outcome Measure Information:
Title
UCLA Loneliness Scale (3 item scale)
Description
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.
Time Frame
Approximately 3.5 months
Title
Generalized Anxiety Disorder Scale (GAD-7; 7 item scale)
Description
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.
Time Frame
Approximately 3.5 months
Title
Generalized Anxiety Disorder Scale (GAD-2; 2 item scale)
Description
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.
Time Frame
Approximately 3.5 months
Title
Patient Health Questionnaire (PHQ-9; 9 item scale)
Description
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.
Time Frame
Approximately 3.5 months
Title
Patient Health Questionnaire (PHQ-2; 2 item scale)
Description
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.
Time Frame
Approximately 3.5 months
Title
Moral Injury Outcome Scale (MIOS-14; 22 item scale)
Description
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.
Time Frame
Approximately 3.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario. Ownership of a smartphone. Exclusion criteria: History of seizures (except febrile seizure). Use of electronic medical devices (e.g., cardiac pacemakers, hearing aids, and defibrillators). A score of ≥ 15 on the Generalized Anxiety Disorder (GAD-7) scale A score of ≥ 20 on the Patient Health Questionnaire (PHQ-9).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Venkat Bhat, MD MSc
Phone
416-360-4000
Ext
76404
Email
Venkat.Bhat@unityhealth.to
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Zuluaga Cuartas, BSc
Phone
416-360-4000
Ext
76404
Email
valentina.zuluaga@unityhealth.to
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkat Bhat, MD MSc
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Zuluaga Cuartas, BSc
Phone
416-360-4000
Ext
76404
Email
valentina.zuluaga@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Venkat Bhat, MD MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Interventions to Understand and Mitigate Stress Response

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