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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887116
• Other study ID #: 20-04021926
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 5, 2023
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Weill Medical College of Cornell University
• Contact: Isabelle McLeod Daphnis, BS
• Phone: 3108256016
• Email: sum4009[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Virtual Reality Exposure Therapy
Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility Indicator: Recruitment	Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.	Baseline
Primary	Feasibility Indicator: Enrollment	Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.	Baseline
Primary	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
Primary	Acceptability Indicator: Satisfaction	Acceptability and treatment satisfaction will be rated with a Likert scale.	Post-Treatment Assessment at approximately 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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