NCT03756545已完成不适用
Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Change in CAPS Total Scores
研究概览
简要总结
The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 - 65 years
- •Able to read and comprehend Hebrew
- •Arrived in the ER because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster.
排除标准
- •Individuals with known claustrophobia
- •Individuals with history of substance abuse
- •Individuals with current or past psychotic or bipolar I disorder
- •Individuals with chronic PTSD at the time of the current trauma
- •Individuals on psychotropic medication or recreational drugs in the week that precedes the MRI
- •Individuals with hearing problems
- •Individuals with head trauma with coma exceeding 30 minutes
- •Individuals which can't perform MRI due to safety reasons (e.g. irremovable metals in their body)
结局指标
主要结局
Change in CAPS Total Scores
时间窗: one-, six- and fourteen months following a traumatic event
The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5).
次要结局
未报告次要终点
研究者
michal roll
Prof. Talma Hendler
Tel-Aviv Sourasky Medical Center
研究点 (1)
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