Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms in a Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms between baseline and week 7
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 efficacy of OTX-601 (intervention) compared to OTX-003 (comparator) 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
- Treatment
- 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
研究组 & 干预措施
OTX-601
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD
干预措施: OTX-601 Digital Therapeutic (Device)
OTX-003
OTX-003 is a smartphone application developed as a comparator to OTX-601 and designed to match its interface while providing no active PTSD treatment.
干预措施: OTX-003 Comparator app (Device)
结局指标
主要结局
Change in PTSD symptoms between baseline and week 7
时间窗: Baseline, 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.
次要结局
- Change in PTSD symptoms at weeks 15 and 27(Week 15, Week 27)
- Change in well-being at weeks 7, 15, and 27(Week 7, Week 15, Week 27)
- Change in Anxiety Sensitivity at weeks 7, 15, and 27(Week 7, Week 15, Week 27)
- Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3(Week 3)
- Change in Generalized Anxiety Disorder at weeks 7, 15, and 27(Week 7, Week 15, Week 27)
- App usability at week 3(Week 3)