Clinical trial NCT04887116: Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
Official title: Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Virtual reality
VR
Healthcare workers
COVID-19
Pandemic
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2021-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Change in Clinician Administered PTSD Score (CAPS-V)
timeFrame: Baseline to approximately five weeks
measure: Feasibility Indicator: Recruitment
timeFrame: Baseline
measure: Feasibility Indicator: Enrollment
timeFrame: Baseline
measure: Feasibility Indicator: Retention
timeFrame: Post-Treatment Assessment at approximately 5 weeks
measure: Acceptability Indicator: Satisfaction
timeFrame: Post-Treatment Assessment at approximately 5 weeks
Secondary outcomes:
measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale
timeFrame: Baseline to approximately five weeks
measure: Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology
timeFrame: Baseline to approximately five weeks
measure: Change in score on the Insomnia Sleep Index
timeFrame: Baseline to approximately five weeks
measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline to approximately five weeks
measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R)
timeFrame: Baseline to approximately five weeks
measure: Change in score on the Modified Moral Injury Events Scale
timeFrame: Baseline to approximately five weeks
measure: Change in score on the Sheehan Disability Scale (SDS)
timeFrame: Baseline to approximately five weeks
measure: Change in score on the Social Adjustment Scale (SAS)
timeFrame: Baseline to approximately five weeks
measure: Change in score on the Moral Distress Scale
timeFrame: Baseline to approximately five weeks
measure: Change in score on the Quality of Life Inventory
timeFrame: Baseline to approximately five weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: JoAnn Difede, PhD
role: PRINCIPAL_INVESTIGATOR
References: