BRAVEMIND: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy System for MST
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safely deliverable
研究概览
简要总结
The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.
The following hypotheses will be tested:
- Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates that are similar to existing Prolonged Exposure (PE) therapy delivered in military samples (20-40%) and by the absence of any critical incidents.
- Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and psychophysiological measures) following treatment.
- Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) compared to wait-list results.
详细描述
Pre-Treatment Assessment:
Potential subjects will be asked to provide a copy of their DD214 to verify their military service record. Once a potential participant has met all screening inclusion and exclusion criteria and consented to participate, the CAPS will be administered to determine current PTSD status.
Randomization:
Following pre-treatment assessment, patients will be randomized to receive VRET (Virtual Reality Exposure Therapy) immediately or wait 6 weeks during which time they will continue to receive usual care. Wait-listed participants will be reassessed prior to beginning their course of treatment with the Clinician Administered PTSD Scale (CAPS), PTSD Checklist-Military (PCL-M), Beck Depression Inventory-II (BDI-II), and psychophysiological measures. This pre-treatment assessment visit will last about 2-3 hours.
Therapy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be 45 males and females between ages of 18 and 65
- •Participants must meet DSM-V criteria for PTSD due to military sexual trauma (MST)
- •Patients must be literate in English
- •Patients must be medically stable
- •Participants must comprehend his or her role in the study and the risks involved
排除标准
- •Patients with a history of mania, schizophrenia, or other psychoses
- •Patients with active suicidal risk
- •Patients with current alcohol or drug dependence
- •Patients unable to wear the VR head mounted display
- •Patients on psychotropic medications must have been on a stable dose for at least 2 months prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study
研究组 & 干预措施
VRET Immediate treatment
Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately
干预措施: Virtual Reality Exposure Therapy (VRET) (Behavioral)
Waitlist
6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment.
干预措施: Virtual Reality Exposure Therapy (VRET) (Behavioral)
结局指标
主要结局
Safely deliverable
时间窗: 2 years
Treatment dropout rates that are similar to existing PE delivered in military samples (20-40%) and by the absence of any critical incidents.
Reduction in PTSD and depression
时间窗: 3 months
Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) following treatment.
Reduction in PTSD and depression: wait-list comparator
时间窗: 6 months
Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHG-9 scores and psychophysiological measures) compared to wait-list results.
次要结局
未报告次要终点
研究者
Barbara O. Rothbaum, PhD
Professor
Emory University