Digital Interventions to Understand and Mitigate Stress Response

Not Applicable

Completed

• Conditions: Distress, Emotional; Stress Reaction; Acute; Stress Response Among Nursing Professionals During the COVID-19
• Interventions: Behavioral: Digital Intervention Group

• Registration Number: NCT05923398
• Lead Sponsor: Unity Health Toronto

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 Timeline

• Study First Submitted: 2022-12-20
• Study Start: 2023-05-01
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Primary Completion: 2023-12-08
• Study Completion: 2023-12-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Digital Intervention 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).

Primary Outcome Measures

Name	Time	Method
Subjective Units of Distress Scale (SUDS)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9; 9 item scale)	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.
Generalized Anxiety Disorder Scale (GAD-7; 7 item scale)	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)	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.
Moral Injury Outcome Scale (MIOS-14; 22 item scale)	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.
Patient Health Questionnaire (PHQ-2; 2 item scale)	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.
UCLA Loneliness Scale (3 item scale)	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.

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada