Digital Interventions to Understand and Mitigate Stress Response

Distress, Emotional Clinical Trial

Official title:

Digital Interventions to Understand and Mitigate Stress Response: Process & Content Evaluation to Move From Feasibility (SRL-4) to Simulated Demonstration (SRL-6)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05923398
• Other study ID #: 22-279
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 8, 2023

Study information

• Verified date: February 2024
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 8, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Distress, Emotional
• Fractures, Stress
• Stress Disorders, Traumatic, 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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
Unity Health Toronto	Boston University, Centre for Addiction and Mental Health, Toronto Metropolitan University, University of Ontario Institute of Technology, University of Ottawa, University of Toronto, Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 3.5 months
Primary	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.	Approximately 3.5 months
Secondary	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.	Approximately 3.5 months
Secondary	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.	Approximately 3.5 months
Secondary	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.	Approximately 3.5 months
Secondary	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.	Approximately 3.5 months
Secondary	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.	Approximately 3.5 months
Secondary	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.	Approximately 3.5 months