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

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Virtual reality, VR, Healthcare workers, COVID-19, Pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Exposure Therapy

Arm Description

Virtual Reality Exposure Therapy

Outcomes

Primary Outcome Measures

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.
Feasibility Indicator: Recruitment
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Retention
Feasibility assessment will include retention defined as the number of participants completing the full intervention.
Acceptability Indicator: Satisfaction
Acceptability and treatment satisfaction will be rated with a Likert scale.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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.
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.
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.

Full Information

First Posted
May 13, 2021
Last Updated
August 8, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04887116
Brief Title
Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers and Patients Consequent to the COVID-19 Pandemic
Official Title
Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers and Patients Consequent to the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Virtual reality, VR, Healthcare workers, COVID-19, Pandemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Exposure Therapy
Arm Type
Experimental
Arm Description
Virtual Reality Exposure Therapy
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Score (CAPS-V)
Description
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-V) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Time Frame
Baseline to approximately five weeks
Title
Feasibility Indicator: Recruitment
Description
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Time Frame
Baseline
Title
Feasibility Indicator: Enrollment
Description
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Time Frame
Baseline
Title
Feasibility Indicator: Retention
Description
Feasibility assessment will include retention defined as the number of participants completing the full intervention.
Time Frame
Post-Treatment Assessment at approximately 5 weeks
Title
Acceptability Indicator: Satisfaction
Description
Acceptability and treatment satisfaction will be rated with a Likert scale.
Time Frame
Post-Treatment Assessment at approximately 5 weeks
Secondary Outcome Measure Information:
Title
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale
Description
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.
Time Frame
Baseline to approximately five weeks
Title
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology
Description
16-item self-report measure. Scored between 0-27. Higher scores indicate greater symptom severity.
Time Frame
Baseline to approximately five weeks
Title
Change in score on the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline to approximately five weeks
Title
Change in score on the PTSD Checklist for DSM-5 (PCL-5)
Description
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Time Frame
Baseline to approximately five weeks
Title
Change in Score on the Occupational Stress Inventory Revised (OSI-R)
Description
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.
Time Frame
Baseline to approximately five weeks
Title
Change in score on the Modified Moral Injury Events Scale
Description
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.
Time Frame
Baseline to approximately five weeks
Title
Change in score on the Sheehan Disability Scale (SDS)
Description
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).
Time Frame
Baseline to approximately five weeks
Title
Change in score on the Social Adjustment Scale (SAS)
Description
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.
Time Frame
Baseline to approximately five weeks
Title
Change in score on the Moral Distress Scale
Description
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.
Time Frame
Baseline to approximately five weeks
Title
Change in score on the Quality of Life Inventory
Description
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.
Time Frame
Baseline to approximately five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle McLeod Daphnis, BS
Phone
3108256016
Email
sum4009@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnn Difede, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle McLeod Daphnis, BS
Phone
301-825-6016
Email
sum4009@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
JoAnn Difede, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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