Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers and Patients Consequent to the COVID-19 Pandemic

Study Overview
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Brief Summary
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Healthcare workers and COVID-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The best-validated treatment for PTSD is exposure therapy. Exposure therapy help patients suffering from PTSD to revisit and overcome their traumatic experiences. Including virtual reality in exposure therapy has a long history in treating PTSD; and has been used to treat military veterans and first-responders following 9/11. The investigators are developing and testing a virtual reality platform to be used in treating healthcare workers and COVID-19 patients who develop PTSD resulting from their experiences in the COVID-19 pandemic. Participants will complete ten ninety minute sessions, twice a week for five weeks aimed at mitigating their symptoms of PTSD. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.

Official Title
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Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers and Patients Consequent to the COVID-19 Pandemic

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Virtual Reality Exposure Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A COVID-19 patient or any healthcare worker providing medical care or support for COVID-19 patients English-speaking Age ≥18 Medically stable Diagnosed with PTSD Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments Stable on psychotropic medication for the prior 60 days Exclusion Criteria: Current significant unstable medical illness such that the participant could not attend sessions regularly or complete assessments Patients who in the investigator's judgment pose a current homicidal, suicidal or other risk Lifetime or Current diagnosis of schizophrenia or other psychotic disorder Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months History of motion sickness or seizures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Exposure Therapy<br>Virtual Reality Exposure Therapy | Behavioral: Virtual Reality Exposure Therapy<br>* Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Score (CAPS-V) | Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-V) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity. | Baseline to approximately five weeks | 
| Feasibility Indicator: Recruitment | Feasibility assessment will include recruitment defined as number of individuals interested in the intervention. | Baseline | 
| Feasibility Indicator: Enrollment | Feasibility assessment will include enrollment defined as number of participants signing the informed consent form. | Baseline | 
| Feasibility Indicator: Retention | Feasibility assessment will include retention defined as the number of participants completing the full intervention. | Post-Treatment Assessment at approximately 5 weeks | 
| Acceptability Indicator: Satisfaction | Acceptability and treatment satisfaction will be rated with a Likert scale. | Post-Treatment Assessment at approximately 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale | Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity. | Baseline to approximately five weeks | 
| Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology | 16-item self-report measure. Scored between 0-27. Higher scores indicate greater symptom severity. | Baseline to approximately five weeks | 
| Change in score on the Pittsburgh Sleep Quality Index (PSQI) | 24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered good. A score of greater than 5 refers to poor sleep quality. | Baseline to approximately five weeks | 
| Change in score on the PTSD Checklist for DSM-5 (PCL-5) | The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity. | Baseline to approximately five weeks | 
| Change in Score on the Occupational Stress Inventory Revised (OSI-R) | The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event. | Baseline to approximately five weeks | 
| Change in score on the Modified Moral Injury Events Scale | 11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury. | Baseline to approximately five weeks | 
| Change in score on the Sheehan Disability Scale (SDS) | 10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). | Baseline to approximately five weeks | 
| Change in score on the Social Adjustment Scale (SAS) | Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome. | Baseline to approximately five weeks | 
| Change in score on the Moral Distress Scale | 21 item self-report measure measuring moral distress (the emotional state that arises from a situation when an individual feels that the ethically correct action to take is different from what he/she is tasked with doing). Score range is 0-336. Higher scores indicate greater moral distress. | Baseline to approximately five weeks | 
| Change in score on the Quality of Life Inventory | The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighbourhood, and community. Higher scores indicate higher level of quality of life. | Baseline to approximately five weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Virtual reality, VR, Healthcare workers, COVID-19, Pandemic