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临床试验/NCT00146900
NCT00146900已完成不适用

Prevention of Post Traumatic Stress Disorder by Early Treatment

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2004年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
298
试验地点
1
主要终点
Post-traumatic Stress Disorder (chronic) by CAPS scores.

研究概览

简要总结

To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.

详细描述

Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Adults survivors of traumatic events

排除标准

  • Traumatic brain injury
  • Lifetime psychosis
  • Life time (prior) PTSD
  • Medical conditions forbidding SSRIs

研究组 & 干预措施

Prolonged Exposure (CBT)

Experimental

Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy

干预措施: Cognitive Behavioral Therapy (Procedure)

Cognitive Therapy

Active Comparator

Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.

干预措施: Cognitive Therapy (Procedure)

SSRI (escitalopram)

Experimental

Twenty milligrams daily of escitalopram (blinded capsules)

干预措施: Escitalopram (Drug)

Placebo

Placebo Comparator

Two concealed placebo pills resembling 10mg escitalopram tablets

干预措施: Placebo (Other)

结局指标

主要结局

Post-traumatic Stress Disorder (chronic) by CAPS scores.

时间窗: Four months, seven months, 14 moths, two years

次要结局

  • Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview)(Four months, seven months, 14 moths, two years)
  • Symptoms of depression as per the Beck Depression Inventory (BDI)(Four months, seven months, 14 moths, two years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aria Shalev

Emeritus Professor of Psychiatry

Hadassah Medical Organization

研究点 (1)

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