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NCT Number: NCT04887116

Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

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.

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Key information

Conditions

Posttraumatic Stress Disorder COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

Isabelle McLeod Daphnis, BS

CONTACT

[email protected]

301-825-6016

JoAnn Difede, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtual reality exposure therapy

Behavioral

Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.

Primary outcomes

  1. Change in Clinician Administered PTSD Score (CAPS-V)

    Time frame: Baseline to approximately five weeks

    Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-V) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

  2. Feasibility Indicator: Recruitment

    Time frame: Baseline

    Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.

  3. Feasibility Indicator: Enrollment

    Time frame: Baseline

    Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

  4. Feasibility Indicator: Retention

    Time frame: Post-Treatment Assessment at approximately 5 weeks

    Feasibility assessment will include retention defined as the number of participants completing the full intervention.

  5. Acceptability Indicator: Satisfaction

    Time frame: Post-Treatment Assessment at approximately 5 weeks

    Acceptability and treatment satisfaction will be rated with a Likert scale.

Secondary outcomes

  1. Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale

    Time frame: Baseline to approximately five weeks

    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.

  2. Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology

    Time frame: Baseline to approximately five weeks

    16-item self-report measure. Scored between 0-27. Higher scores indicate greater symptom severity.

  3. Change in score on the Insomnia Sleep Index

    Time frame: Baseline to approximately five weeks

    7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.

  4. Change in score on the PTSD Checklist for DSM-5 (PCL-5)

    Time frame: Baseline to approximately five weeks

    The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

  5. Change in Score on the Occupational Stress Inventory Revised (OSI-R)

    Time frame: Baseline to approximately five weeks

    The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.

  6. Change in score on the Modified Moral Injury Events Scale

    Time frame: Baseline to approximately five weeks

    11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree).

    Score range is 11-66, with higher scores reflecting greater moral injury.

  7. Change in score on the Sheehan Disability Scale (SDS)

    Time frame: Baseline to approximately five weeks

    10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

  8. Change in score on the Social Adjustment Scale (SAS)

    Time frame: Baseline to approximately five weeks

    Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome.

  9. Change in score on the Moral Distress Scale

    Time frame: Baseline to approximately five weeks

    21 item self-report measure measuring moral distress (the emotional state that arises from a situation when an individual feels that the ethically correct action to take is different from what he/she is tasked with doing). Score range is 0-336. Higher scores indicate greater moral distress.

  10. Change in score on the Quality of Life Inventory

    Time frame: Baseline to approximately five weeks

    The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighbourhood, and community. Higher scores indicate higher level of quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle McLeod Daphnis, BS

CONTACT

[email protected]

3108256016

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Cornell University

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 14, 2021
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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