Prevention of Post Traumatic Stress Disorder by Early Treatment
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
- 否
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)
Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
干预措施: Cognitive Behavioral Therapy (Procedure)
Cognitive Therapy
Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
干预措施: Cognitive Therapy (Procedure)
SSRI (escitalopram)
Twenty milligrams daily of escitalopram (blinded capsules)
干预措施: Escitalopram (Drug)
Placebo
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
Aria Shalev
Emeritus Professor of Psychiatry
Hadassah Medical Organization
