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临床试验/NCT02033395
NCT02033395Unknown不适用

A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).

研究概览

简要总结

This observational study follows subjects who have been exposed to a traumatic event and are at risk of developing PTSD symptoms. Participants are recruited within six hours of a traumatic event, and, starting from the recruitment session, are then examined on six set points of time within a period of thirteen months. The examinations include both biological studies of cortisol in hair, blood and saliva, and psychological examinations and questionaires that assess the development and severity of PTSD symptoms.

The novel method of sampling hair cortisol allows investigators to retroactively estimate the mean levels of blood cortisol during the tree months prior to the sampling.

The study aims at further illuminating the correlation between cortisol levels both prior and following a traumatic event, and the development and severity of PTSD symptoms

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Experienced a traumatic and were at risk (or perceived risk) of serious injury to themselves or others in their surroundings.
  • Signed an informed consent form.

排除标准

  • Age under 18 or over
  • Severe or complex physical injury, such as severe head trauma, massive burns or injuries that require surgery under full anesthesia.
  • A personal history of Psychotic state or PTSD.
  • Pregnancy
  • Weight below 45 Kg or over 120 Kg.
  • Hair shorter than 1.5 cm.

结局指标

主要结局

PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).

时间窗: 13 months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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