About this trial
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
This trial does not accept healthy volunteersQualifiers
A COVID-19 patient or any healthcare worker providing medical care or support who experiences occupational-related trauma
English-speaking
Age ≥18
Medically stable
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Virtual Reality Exposure Therapy
BehavioralTen ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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 Insomnia Sleep Index
7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.
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.
Sponsors and contacts
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Weill Medical College of Cornell University
Lead sponsor
Cornell University
Collaborator