Recruiting
Early Phase 1

Virtual Reality

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04887116

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Exposure Therapy

Study Details

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 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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT04887116

Start date

Oct 5, 2023

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Exposure Therapy

Virtual Reality Exposure Therapy

Interventions

Virtual Reality Exposure Therapy

Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.

Primary outcome measure

  • Change in Clinician Administered PTSD Score (CAPS-V) [ Time Frame: Baseline to approximately five weeks ]
  • Feasibility Indicator: Recruitment [ Time Frame: Baseline ]
  • Feasibility Indicator: Enrollment [ Time Frame: Baseline ]
  • Feasibility Indicator: Retention [ Time Frame: Post-Treatment Assessment at approximately 5 weeks ]
  • Acceptability Indicator: Satisfaction [ Time Frame: Post-Treatment Assessment at approximately 5 weeks ]

Central Contacts and Locations

Central contacts

Isabelle McLeod Daphnis, BS

3108256016sum4009@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Isabelle McLeod Daphnis, BS

3018256016sum4009@med.cornell.edu

Principal Investigator:

JoAnn Difede, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • PTSD
  • Virtual reality
  • VR
  • Healthcare workers
  • COVID-19
  • Pandemic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.