Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

October 27, 2025 updated by: Weill Medical College of Cornell University
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 environment to treat PTSD including sub threshold PTSD symptoms in HCWs who experience occupational related trauma (e.g., working with COVID-19 patients) and COVID-19 patients. An independent evaluator will assess symptoms of PTSD and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. Participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of PTSD. Remote participants will receive VR headsets after the baseline assessment and will keep them for the duration of the study. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • JoAnn Difede, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A COVID-19 patient or any healthcare worker providing medical care or support who experiences occupational-related trauma
  • English-speaking
  • Age ≥18
  • Medically stable
  • Diagnosed with PTSD or sub threshold 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Exposure Therapy
Behavioral: Virtual Reality Exposure Therapy
Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician Administered PTSD Score (CAPS-V)
Time Frame: Baseline to approximately five weeks
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
Time Frame: Baseline
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Baseline
Feasibility Indicator: Enrollment
Time Frame: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Baseline
Feasibility Indicator: Retention
Time Frame: Post-Treatment Assessment at approximately 5 weeks
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
Time Frame: Post-Treatment Assessment at approximately 5 weeks
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
Time Frame: Baseline to approximately five weeks

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
Time Frame: Baseline to approximately five weeks
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 PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline to approximately five weeks
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)
Time Frame: Baseline to approximately five weeks
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
Time Frame: Baseline to approximately five weeks

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)
Time Frame: Baseline to approximately five weeks
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)
Time Frame: Baseline to approximately five weeks
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
Time Frame: Baseline to approximately five weeks
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
Time Frame: Baseline to approximately five weeks
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
Change in score on the Insomnia Sleep Index
Time Frame: Baseline to approximately five weeks
7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.
Baseline to approximately five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Cornell University

Investigators

  • Principal Investigator: JoAnn Difede, PhD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-04021926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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