Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in Clinician Administered PTSD Score (CAPS-V) [Срок оценки: Baseline to approximately five weeks]
• Feasibility Indicator: Recruitment [Срок оценки: Baseline]
• Feasibility Indicator: Enrollment [Срок оценки: Baseline]
• Feasibility Indicator: Retention [Срок оценки: Post-Treatment Assessment at approximately 5 weeks]
• Acceptability Indicator: Satisfaction [Срок оценки: Post-Treatment Assessment at approximately 5 weeks]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT04887116 · 20-04021926

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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