Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Virtual Reality Exposure TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to approximately five weeks
2

Feasibility Indicator: Recruitment

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

Time frame
Baseline
3

Feasibility Indicator: Enrollment

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

Time frame
Baseline
4

Feasibility Indicator: Retention

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

Time frame
Post-Treatment Assessment at approximately 5 weeks

Secondary outcomes

1

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.

Time frame
Baseline to approximately five weeks
2

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.

Time frame
Baseline to approximately five weeks
3

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.

Time frame
Baseline to approximately five weeks
4

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.

Time frame
Baseline to approximately five weeks

Other outcomes

Sponsors and contacts

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