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临床试验/NCT00889005
NCT00889005已完成不适用

Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2009年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
2
主要终点
Severity of PTSD Symptoms

研究概览

简要总结

This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face CBT one month from the traumatic event. The study's main hypothesis is that early telephone-based CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.

详细描述

Post-traumatic Stress Disorder (PTSD) is a prevalent and pervasive mental disorder. Studies have shown that there is a significant reluctance to use mental health services by trauma-exposed individuals at high risk for developing PTSD. Providing clinical services in combat or disaster zone might be difficult. Trauma-focused cognitive behavioral therapy (CBT) effectively reduces the prevalence of PTSD among recent survivors. Telephone based CBT was found to be effective in mood and anxiety disorders, but has not been tried in PTSD. Establishing the effectiveness of telephone based CBT has significant service delivery and public health implications. Preventing PTSD significantly reduces individuals' suffering and disability We will screen, by telephone, up to 1200 survivors of traumatic events, from a general hospital emergency department trauma registry list, randomize the first 240 with ASD or Acute PTSD to either early, telephone based cognitive behavioral therapy (ET_CBT) (n=120) or a no-treatment control condition (n=120). We will provide five sessions of ET-CBT to the former and compare the two groups three and eight months later.

Survivors from both groups who will continue to have PTSD at three months (after either treatment or waiting list), will receive 12 sessions of face-to-face, trauma focused CBT. A first phase of the study will consist of establishing the acceptance of ET-CBT and its main components (e.g., exposure to traumatic reminders) by survivors, and optimizing the protocol. It will involve 20 survivors and no randomization. Subsequent to that phase we will start recruiting for the main study. The study's main hypothesis is that early CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.

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
None

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

  • Exposure to psychologically traumatic events
  • Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder
  • Up to four weeks after trauma exposure

排除标准

  • Chronic PTSD
  • Past and present psychosis, bipolar disorder, opiate or stimulants use
  • Medical or surgical condition that interfere with subjects ability to participate in the study or sign an informed consent
  • Lack of fluency in the study's main language (Hebrew)

研究组 & 干预措施

Cognitive Behavioral Therapy

Experimental

Five sessions of trauma-focused, telephone based cognitive behavioral therapy, followed by assessment and referral to clinical treatment if needed.

干预措施: Telephone Based Cognitive Behavioral Therapy (Other)

Waitlist control group

No Intervention

Five weeks without active intervention, followed by assessment and referral to clinical treatment if needed.

结局指标

主要结局

Severity of PTSD Symptoms

时间窗: Up to ten months

Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria

次要结局

未报告次要终点

研究者

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

Aria Shalev

Professor of Psychiatry

Hadassah Medical Organization

研究点 (2)

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