NCT04887116 Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
| NCT ID | NCT04887116 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-10-05 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
JoAnn Difede, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT04887116 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04887116 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04887116 currently recruiting?
Yes, NCT04887116 is actively recruiting participants. Contact the research team at sum4009@med.cornell.edu for enrollment information.
Where is the NCT04887116 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04887116 clinical trial?
NCT04887116 is sponsored by Weill Medical College of Cornell University. The principal investigator is JoAnn Difede, PhD at Weill Medical College of Cornell University. The trial plans to enroll 20 participants.