Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility Indicator: Enrollment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A COVID-19 patient or any healthcare worker providing medical care or support who experiences occupational-related trauma
- •English-speaking
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Reality Exposure Therapy
Virtual Reality Exposure Therapy
干预措施: Virtual Reality Exposure Therapy (Behavioral)
结局指标
主要结局
Feasibility Indicator: Enrollment
时间窗: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Recruitment
时间窗: Baseline
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Retention
时间窗: Post-Treatment Assessment at approximately 5 weeks
Feasibility assessment will include retention defined as the number of participants completing the full intervention.
Change in Clinician Administered PTSD Score (CAPS-V)
时间窗: 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.
Acceptability Indicator: Satisfaction
时间窗: Post-Treatment Assessment at approximately 5 weeks
Acceptability and treatment satisfaction will be rated with a Likert scale.
次要结局
- Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale(Baseline to approximately five weeks)
- Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology(Baseline to approximately five weeks)
- Change in score on the Insomnia Sleep Index(Baseline to approximately five weeks)
- Change in score on the PTSD Checklist for DSM-5 (PCL-5)(Baseline to approximately five weeks)
- Change in Score on the Occupational Stress Inventory Revised (OSI-R)(Baseline to approximately five weeks)
- Change in score on the Modified Moral Injury Events Scale(Baseline to approximately five weeks)
- Change in score on the Sheehan Disability Scale (SDS)(Baseline to approximately five weeks)
- Change in score on the Social Adjustment Scale (SAS)(Baseline to approximately five weeks)
- Change in score on the Moral Distress Scale(Baseline to approximately five weeks)
- Change in score on the Quality of Life Inventory(Baseline to approximately five weeks)