Posttraumatic Stress Disorder
Conditions
Keywords
PTSD, Virtual reality, VR, Healthcare workers, COVID-19, Pandemic
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.
Interventions
BEHAVIORALVirtual Reality Exposure Therapy
Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.
Sponsors
Weill Medical College of Cornell University
Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Score (CAPS-V) | 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 | Baseline | Feasibility assessment will include recruitment defined as number of individuals interested in the intervention. |
| Feasibility Indicator: Enrollment | Baseline | Feasibility assessment will include enrollment defined as number of participants signing the informed consent form. |
| Feasibility Indicator: Retention | 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 | Post-Treatment Assessment at approximately 5 weeks | Acceptability and treatment satisfaction will be rated with a Likert scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale | 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. |
| Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology | Baseline to approximately five weeks | 16-item self-report measure. Scored between 0-27. Higher scores indicate greater symptom severity. |
| Change in score on the Insomnia Sleep Index | Baseline to approximately five weeks | 7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity. |
| Change in score on the PTSD Checklist for DSM-5 (PCL-5) | 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. |
| Change in Score on the Occupational Stress Inventory Revised (OSI-R) | 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. |
| Change in score on the Modified Moral Injury Events Scale | 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. |
| Change in score on the Sheehan Disability Scale (SDS) | 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). |
| Change in score on the Social Adjustment Scale (SAS) | 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. |
| Change in score on the Moral Distress Scale | 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. |
| Change in score on the Quality of Life Inventory | 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. |
Countries
United States
Contacts
CONTACTIsabelle McLeod Daphnis, BS
PRINCIPAL_INVESTIGATORJoAnn Difede, PhD
Weill Medical College of Cornell University
Outcome results
None listed