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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Virtual Reality Exposure Therapy 		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.

Recruiting Locations

Weill Cornell Medicine
New York, New York 10065
Contact:
Isabelle McLeod Daphnis, BS
301-825-6016
sum4009@med.cornell.edu

More Details

NCT ID
NCT04887116
Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

Isabelle McLeod Daphnis, BS
3108256016
sum4009@med.cornell.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.