Dosage, Feasibility, Acceptability and Usability of OTX-601
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-V (PCL-5)
研究概览
简要总结
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
详细描述
The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Posttraumatic stress disorder (PTSD) diagnosis
- •Anxiety Sensitivity Index 3 (ASI-3) scores above 24
- •PTSD Checklist for DSM-V (PCL-5) scores above 30
- •Understands and speaks English
- •Access to a smartphone that is connected to the internet
排除标准
- •Score of 24 or lower on the ASI-3
- •Score of 30 and below on the PCL-5
- •No PTSD diagnosis
- •Active psychosis
- •Acute intoxication during study baseline
- •Enrolled in another treatment research study
- •Medical illness that would prevent the completion of interoceptive exposure exercises
结局指标
主要结局
PTSD Checklist for DSM-V (PCL-5)
时间窗: Baseline, week 1, week 2, week 3, and week 7
Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.
System Usability Scale (SUS)
时间窗: week 1, week 2, and week 3
App usability will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.
次要结局
- Anxiety Sensitivity Index 3 (ASI-3)(Baseline, week 1, week 2, week 3 and week 7)