Posttraumatic Stress DisorderEarly Phase 1NCT04887116
Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
A Early Phase 1 study testing Virtual Reality Exposure Therapy in people with Posttraumatic Stress Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Virtual Reality Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Isabelle McLeod Daphnis, BS, 3018256016, sum4009@med.cornell.edu
JoAnn Difede, PhD
About this study
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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Virtual Reality Exposure Therapy
- Keywords
- PTSD, Virtual reality, VR, Healthcare workers, COVID-19, Pandemic
- Medical subject headings
- Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure TherapyBehavioural
Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Virtual Reality Exposure Therapy Receives: Behavioral: Virtual Reality Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to approximately five weeks
Feasibility Indicator: Recruitment
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Measured: Baseline
Feasibility Indicator: Enrollment
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Measured: Baseline
Feasibility Indicator: Retention
Feasibility assessment will include retention defined as the number of participants completing the full intervention.
Measured: Post-Treatment Assessment at approximately 5 weeks
Acceptability Indicator: Satisfaction
Acceptability and treatment satisfaction will be rated with a Likert scale.
Measured: Post-Treatment Assessment at approximately 5 weeks
Secondary outcomes (10)
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.
Measured: Baseline to approximately five weeks
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.
Measured: Baseline to approximately five weeks
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.
Measured: Baseline to approximately five weeks
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.
Measured: Baseline to approximately five weeks
Change in Score on the Occupational Stress Inventory Revised (OSI-R)
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.
Measured: Baseline to approximately five weeks
Change in score on the Modified Moral Injury Events Scale
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.
Measured: Baseline to approximately five weeks
Change in score on the Sheehan Disability Scale (SDS)
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).
Measured: Baseline to approximately five weeks
Change in score on the Social Adjustment Scale (SAS)
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.
Measured: Baseline to approximately five weeks
Change in score on the Moral Distress Scale
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.
Measured: Baseline to approximately five weeks
Change in score on the Quality of Life Inventory
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.
Measured: Baseline to approximately five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start5 Oct 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Sponsor
- Investigators
- JoAnn Difede, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887116
- Sponsor's protocol ID
- 20-04021926
- Status last verified
- Sep 2026
- First submitted
- 13 May 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
- ClinicalTrials.gov ID
- NCT04887116
- Acronym / sponsor ID
- 20-04021926
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Virtual reality, VR, Healthcare workers, COVID-19, Pandemic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Behavioral: Virtual Reality Exposure TherapyVirtual Reality Exposure Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Exposure TherapyTen ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person. | Behavioural | Virtual Reality Exposure Therapy |
Primary outcome
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.
Feasibility Indicator: Recruitment
Time frame: Baseline
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment
Time frame: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
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.
Acceptability Indicator: Satisfaction
Time frame: Post-Treatment Assessment at approximately 5 weeks
Acceptability and treatment satisfaction will be rated with a Likert scale.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JoAnn Difede, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual Reality Exposure Therapy in people with Posttraumatic Stress Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle McLeod Daphnis, BS (3108256016, sum4009@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician Administered PTSD Score (CAPS-V) (time frame: Baseline to approximately five weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.