Moral InjuryVRNCT05001542
Digital Interventions for Detection and Reduction of Moral Distress
A study testing Educational moral injury video in people with Moral Injury and Distress, Emotional, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Stress, anxiety, distress and depression are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Factors underlying distress and resilience are unknown and there are no evidence based interventions to impact the mental wellbeing of frontline healthcare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moral Injury, Distress, Emotional
- What is being tested?
- Educational moral injury video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2021to 30 Aug 2021
- 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
- Staff or healthcare providers working at Unity Health Toronto
- 18 years of age or older
- Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher)
Who cannot join
- Non-Unity Health Toronto staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could Digital Interventions Help Understand And "Flatten The Curve" Of Distress Due To Moral Injury Among Health Care Workers During The COVID Pandemic?
Stress, anxiety, distress and depression are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Factors underlying distress and resilience are unknown and there are no evidence based interventions to impact the mental wellbeing of frontline healthcare workers. This study will evaluate a novel virtual reality platform to gather the "distress experience" of frontline healthcare workers at Unity Health Toronto in real time during the ongoing COVID pandemic by developing and showing feasibility of digital technology (Virtual Reality (VR) and mobile app) as a digital platform to understand the causes and ultimately reduce the moral distress of healthcare providers during the COVID-19 pandemic. The project will develop innovations which can be used for future pandemics and other contexts prone to producing moral distress and injury.
- Conditions
- Moral Injury, Distress, Emotional
- Being tested
- Educational moral injury video
- Keywords
- Depression, Anxiety, Stress, Moral Injury, Moral Distress, Loneliness
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational moral injury videoOther
Educational video that addresses the identification of moral injury and distress in frontline healthcare workers during COVID-19; offers available interventions at the levels of individual, team and organization
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | VR simulation exercise with a digital follow-up component to help assess the physiological and psychological indicators of moral distress Receives: Other: Educational moral injury video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility evaluation of the virtual reality environment
The primary outcome measure will be a comparison of MIOS (Moral Injury Outcome Scale) and PSS (Perceived Stress Scale) scores before and after watching an educational video on moral injury; feasibility of this platform will be assessed based on a feasibility questionnaire and changes in score.
Measured: 60 minutes (during the intervention)
Secondary outcomes (1)
Feasibility evaluation of a mobile platform to understand the continuum of stress and moral distress.
Feasibility of the mobile platform will be measured based on dropout rate
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start31 May 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
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 Moral InjuryStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Users will go through a VR experiment before and after a brief interventional informative video describing moral distress. The VR experiment is a simulation that will lead the participant through a stressful experience about moral distress during the COVID-19 pandemic. Before, during, and after the experiment, active and physiological data will be collected from the participant to monitor their level of acute distress and health, respectively. Following the experiment, active and passive data will be collected on each user through the investigators' mobile platform (DiiG) for longitudinal monitoring of moral distress and injury.
- Masking
- None (open label)
- Enrolment
- 15 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, McMaster University
- Responsible party
- Principal investigator, Venkat.Bhat, Unity Health Toronto
- Investigators
- Venkat Bhat, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001542
- Sponsor's protocol ID
- 21-066
- Other IDs
- CPCA-0592
- Acronym
- VR
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espinola CW, Nguyen B, Torres A, Sim W, Rueda A, Beavers L, Campbell DM, Jung H, Lou W, Kapralos B, Peter E, Dubrowski A, Krishnan S, Bhat V. Digital Interventions for Stress Among Frontline Health Care Workers: Results From a Pilot Feasibility Cohort Trial. JMIR Serious Games. 2024 Jan 9;12:e42813. doi: 10.2196/42813.
PubMed 38194247Nguyen B, Torres A, Sim W, Kenny D, Campbell DM, Beavers L, Lou W, Kapralos B, Peter E, Dubrowski A, Krishnan S, Bhat V. Digital Interventions to Reduce Distress Among Health Care Providers at the Frontline: Protocol for a Feasibility Trial. JMIR Res Protoc. 2022 Feb 16;11(2):e32240. doi: 10.2196/32240.
PubMed 34871178
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Digital Interventions Help Understand And "Flatten The Curve" Of Distress Due To Moral Injury Among Health Care Workers During The COVID Pandemic?
- ClinicalTrials.gov ID
- NCT05001542
- Acronym / sponsor ID
- VR / 21-066
- Conditions
- Moral Injury, Distress, Emotional
- Keywords
- Depression, Anxiety, Stress, Moral Injury, Moral Distress, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University, University of Toronto, University of Ontario Institute of Technology, McMaster University
- Study start
- 31 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Aug 2021 (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 depression are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Factors underlying distress and resilience are unknown and there are no evidence based interventions to impact the mental wellbeing of frontline healthcare workers. This study will evaluate a novel virtual reality platform to gather the "distress experience" of frontline healthcare workers at Unity Health Toronto in real time during the ongoing COVID pandemic by developing and showing feasibility of digital technology (Virtual Reality (VR) and mobile app) as a digital platform to understand the causes and ultimately reduce the moral distress of healthcare providers during the COVID-19 pandemic. The project will develop innovations which can be used for future pandemics and other contexts prone to producing moral distress and injury.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Users will go through a VR experiment before and after a brief interventional informative video describing moral distress. The VR experiment is a simulation that will lead the participant through a stressful experience about moral distress during the COVID-19 pandemic. Before, during, and after the experiment, active and physiological data will be collected from the participant to monitor their level of acute distress and health, respectively. Following the experiment, active and passive data will be collected on each user through the investigators' mobile platform (DiiG) for longitudinal monitoring of moral distress and injury.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Educational moral injury videoVR simulation exercise with a digital follow-up component to help assess the physiological and psychological indicators of moral distress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Staff or healthcare providers working at Unity Health Toronto
- 18 years of age or older
- Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher)
Key exclusion criteria (1 listed)
- Non-Unity Health Toronto staff
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 |
|---|---|---|
| Educational moral injury videoEducational video that addresses the identification of moral injury and distress in frontline healthcare workers during COVID-19; offers available interventions at the levels of individual, team and organization | Other | Experimental Arm |
Primary outcome
Feasibility evaluation of the virtual reality environment
Time frame: 60 minutes (during the intervention)
The primary outcome measure will be a comparison of MIOS (Moral Injury Outcome Scale) and PSS (Perceived Stress Scale) scores before and after watching an educational video on moral injury; feasibility of this platform will be assessed based on a feasibility questionnaire and changes in score.
1 secondary outcome
Feasibility evaluation of a mobile platform to understand the continuum of stress and moral distress.
Time frame: Up to 8 weeks
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 7 Oct 2021.
- Derived from this study: PubMed 38194247Espinola CW, Nguyen B, Torres A, Sim W, Rueda A, Beavers L, Campbell DM, Jung H, Lou W, Kapralos B, Peter E, Dubrowski A, Krishnan S, Bhat V. Digital Interventions for Stress Among Frontline Health Care Workers: Results From a Pilot Feasibility Cohort Trial. JMIR Serious Games. 2024 Jan 9;12:e42813. doi: 10.2196/42813.
- Derived from this study: PubMed 34871178Nguyen B, Torres A, Sim W, Kenny D, Campbell DM, Beavers L, Lou W, Kapralos B, Peter E, Dubrowski A, Krishnan S, Bhat V. Digital Interventions to Reduce Distress Among Health Care Providers at the Frontline: Protocol for a Feasibility Trial. JMIR Res Protoc. 2022 Feb 16;11(2):e32240. doi: 10.2196/32240.
- 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 Educational moral injury video in people with Moral Injury and Distress, Emotional, 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 3 inclusion and 1 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 7 Oct 2021. 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?
Feasibility evaluation of the virtual reality environment (time frame: 60 minutes (during the intervention)). 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 NCT05001542, 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 7 Oct 2021.