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Recruiting NCT04887116

Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

Early Phase I Interventional Posttraumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Exposure Therapy.
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale [Time frame: Baseline to approximately five weeks]
  • Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology [Time frame: Baseline to approximately five weeks]
  • Change in score on the Insomnia Sleep Index [Time frame: Baseline to approximately five weeks]
  • Change in score on the PTSD Checklist for DSM-5 (PCL-5) [Time frame: Baseline to approximately five weeks]
  • Change in Score on the Occupational Stress Inventory Revised (OSI-R) [Time frame: Baseline to approximately five weeks]
  • Change in score on the Modified Moral Injury Events Scale [Time frame: Baseline to approximately five weeks]
  • Change in score on the Sheehan Disability Scale (SDS) [Time frame: Baseline to approximately five weeks]
  • Change in score on the Social Adjustment Scale (SAS) [Time frame: Baseline to approximately five weeks]
  • Change in score on the Moral Distress Scale [Time frame: Baseline to approximately five weeks]
  • Change in score on the Quality of Life Inventory [Time frame: Baseline to approximately five weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT04887116 · 20-04021926

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗