NCT05001542

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

July 28, 2021

Last Update Submit

October 5, 2021

Conditions

Keywords

DepressionAnxietyStressMoral InjuryMoral DistressLoneliness

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 minutes (during the intervention)

Secondary Outcomes (1)

  • Feasibility evaluation of a mobile platform to understand the continuum of stress and moral distress.

    Up to 8 weeks

Study Arms (1)

Experimental Arm

EXPERIMENTAL

VR simulation exercise with a digital follow-up component to help assess the physiological and psychological indicators of moral distress

Other: Educational moral injury video

Interventions

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

Experimental Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Staff or healthcare providers working at Unity Health Toronto
  • 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)
  • \- Non-Unity Health Toronto staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

  • 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.

  • Nguyen 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Venkat Bhat, MD MSc

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 12, 2021

Study Start

May 31, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

October 7, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations