Distress, EmotionalNCT05923398
Digital Interventions to Understand and Mitigate Stress Response
A study testing Digital Intervention Group in people with Distress, Emotional and Stress Response Among Nursing Professionals During the COVID-19, run by Unity Health Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distress, Emotional, Stress Response Among Nursing Professionals During the COVID-19, Stress Reaction; Acute
- What is being tested?
- Digital Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2023to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario.
- Ownership of a smartphone.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Interventions to Understand and Mitigate Stress Response: Process & Content Evaluation to Move From Feasibility (SRL-4) to Simulated Demonstration (SRL-6)
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.
Read the 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.
- Conditions
- Distress, Emotional, Stress Response Among Nursing Professionals During the COVID-19, Stress Reaction; Acute
- Being tested
- Digital Intervention Group
- Keywords
- Moral distress, Stress, Virtual Reality, Wearables, Web-based intervention, Nursing professionals, Nursing staff, Distress, COVID-19
- Medical subject headings
- Stress Disorders, Traumatic, Acute, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intervention GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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). Receives: Behavioral: Digital Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 3.5 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 May 2023
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Venkat Bhat, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923398
- Sponsor's protocol ID
- 22-279
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rueda A, Martin J, Parkington K, Perivolaris A, Teferra BG, Lee GH, Tassone VK, Lin Q, Ivanov M, Darnell B, Beavers L, Campbell DM, Torres A, Lou W, Nazarov A, Ashbaugh A, Kapralos B, Litz B, Jetly R, Dubrowski A, Strudwick G, Krishnan S, Bhat V. Digital Health Monitoring and Intervention Suite for Stress in Frontline Nurses: Prospective Cohort Trial. JMIR Form Res. 2026 Jun 11;10:e77818. doi: 10.2196/77818.
PubMed 42275639Martin 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.
PubMed 38709554
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Interventions to Understand and Mitigate Stress Response: Process & Content Evaluation to Move From Feasibility (SRL-4) to Simulated Demonstration (SRL-6)
- ClinicalTrials.gov ID
- NCT05923398
- Acronym / sponsor ID
- 22-279
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- 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
- Study start
- 1 May 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Digital Intervention GroupDuring 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario.
- Ownership of a smartphone.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Intervention GroupParticipants 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. | Behavioural | Experimental Group |
Primary outcome
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.
6 secondary outcomes
UCLA Loneliness Scale (3 item scale)
Time frame: Approximately 3.5 months
Generalized Anxiety Disorder Scale (GAD-7; 7 item scale)
Time frame: Approximately 3.5 months
Generalized Anxiety Disorder Scale (GAD-2; 2 item scale)
Time frame: Approximately 3.5 months
Patient Health Questionnaire (PHQ-9; 9 item scale)
Time frame: Approximately 3.5 months
Patient Health Questionnaire (PHQ-2; 2 item scale)
Time frame: Approximately 3.5 months
Moral Injury Outcome Scale (MIOS-14; 22 item scale)
Time frame: Approximately 3.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 42275639Rueda A, Martin J, Parkington K, Perivolaris A, Teferra BG, Lee GH, Tassone VK, Lin Q, Ivanov M, Darnell B, Beavers L, Campbell DM, Torres A, Lou W, Nazarov A, Ashbaugh A, Kapralos B, Litz B, Jetly R, Dubrowski A, Strudwick G, Krishnan S, Bhat V. Digital Health Monitoring and Intervention Suite for Stress in Frontline Nurses: Prospective Cohort Trial. JMIR Form Res. 2026 Jun 11;10:e77818. doi: 10.2196/77818.
- Derived from this study: PubMed 38709554Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkat Bhat, MD MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention Group in people with Distress, Emotional and Stress Response Among Nursing Professionals During the COVID-19, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Units of Distress Scale (SUDS) (time frame: Approximately 3.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05923398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.