Prevention of PTSD by Early Treatment II: Telephone-Based CBT

描述（由申请人提供）：提出的工作目标是开发一种早期的、基于电话的、以创伤为重点的认知行为治疗干预（ET-CBT），并评估其预防创伤后应激障碍（PTSD）的功效。创伤后应激障碍是一种常见的、致残的、难以治疗的疾病。目前的证据支持面对面以创伤为中心的认知行为疗法（CBT）在预防PTSD方面的有效性。然而，所需的临床资源是有限的，特别是在受战争、恐怖或灾害影响的地区。寻找通过远程通信提供CBT的方法是当务之急。以电话为基础的CBT已经成功地用于治疗焦虑和情绪障碍。对受威胁人口的研究表明，电话支持服务被广泛使用。拟议的工作将改编现有的基于电话的CBT协议，预先测试干预的初步版本的一致性，可行性和可接受性；开发一种先进的版本，并在大型随机对照试验（RCT）中进行评估。在初步评估确定其可行性、耐受性和潜在的有益效果后，一项开放标签研究将评估20名幸存者并建立干预手册。知名顾问将参与设计干预措施并监测其执行情况。对于RCT，我们将筛选1500名创伤事件幸存者，来自一家综合医院急诊创伤登记处，将前200名患有急性应激障碍（ASD）或急性创伤后应激障碍（PTSD）的患者随机分配到ET-CBT组（n=100）或无治疗组（n=100），在创伤事件发生后一个月内为前者提供ET-CBT，并在三个月后比较两组。三个月后患有PTSD的幸存者将接受面对面的CBT治疗。第二次评估，在8个月时，将检查ET-CBT恢复的稳定性，以及对ET-CBT无反应的患者进行面对面CBT的有益效果。这项建议是根据题为“暴力和创伤对精神健康的影响（PA PAR-07-315）”的R34机制提出的，该机制鼓励发展新的或经过调整的干预措施。它针对医学研究所（IOM） 2007年的建议“促进对创伤后应激障碍早期干预的具体研究”。ET-CBT的成功开发将有助于解决一个主要的服务提供问题，并为预防PTSD提供一个新的工具。它将使战争和受灾地区的幸存者能够得到及时治疗。拟议的干预措施可以很容易地转化为基于网络的语音和图像通信工具，供越来越多的人口使用。

DESCRIPTION (provided by applicant): The goal of the proposed work is to develop an early, telephone-based, trauma focused cognitive behavioral therapy intervention (ET-CBT) and evaluate its efficacy in preventing post-traumatic stress disorder (PTSD). PTSD is frequent, disabling and treatment resistant. Current evidence supports the efficacy of face-to-face trauma-focused cognitive behavioral therapy (CBT) in preventing PTSD. The required clinical resources are limited, however, particularly in war, terror or disaster-affected areas. Finding ways to deliver CBT via remote telecommunications is a high priority. Telephone based CBT has been successfully delivered in anxiety and mood disorders. Studies of populations under threat show that telephone support services are widely used. The proposed work will adapt an existing CBT protocol for telephone based delivery, pre- test a preliminary version of the intervention for consistency, feasibility and acceptance; develop an advanced version and evaluate it in a large randomized controlled trial (RCT). Following a preliminary evaluation that established it feasibility, tolerance and potential for beneficial effect, an open-label study will evaluate 20 survivors and establish the intervention's manual. Eminent consultants will participate in designing the intervention and monitoring its implementation. For the RCT, we will screen 1500 survivors of traumatic events, from a general hospital ER trauma registry, randomize the first 200 who have Acute Stress Disorder (ASD) or Acute PTSD to either ET-CBT (n=100) or no-treatment condition (n=100), provide ET-CBT to the former within a month of the traumatic event, and compare the two groups at three months. Survivors with PTSD at three months will receive face-to- face CBT. A second evaluation, at eight months will examine the stability of recovery with ET- CBT and added beneficial effect of in-person CBT in who did not respond to ET-CBT. This proposal is molded on the R34 mechanism entitled "Mental Health Consequences of Violence And Trauma (PA PAR-07-315)" that encourages the development of new or adapted interventions. It addresses to the Institute of Medicine (IOM) 2007 recommendation to "Promote specific research on early intervention in PTSD." The successful development of ET-CBT will contribute to solving a major service-delivery problem and provide a new tool for preventing PTSD. It will enable timely treatment to survivors in war and disaster-affected areas. The proposed interventions can be readily converted to web-based vehicles of voice- and image communication, available to a growing segment of the population. PUBLIC HEALTH RELEVANCE: Post-traumatic stress disorder (PTSD) is chronic, disabling and frequent among war veterans and survivors of terror, disasters and accidents. An early short psychological intervention, named Cognitive Behavioral Therapy (CBT), effectively prevents PTSD in many cases. CBT, however, is expensive and rarely available in disaster and war-prone areas. Telephone support services are widely used by threatened populations. Telephone-based CBT was effective in other anxiety and mood disorders. The proposed work will develop telephone-based CBT and test its ability to prevent chronic PTSD in recent trauma survivors with early PTSD symptoms. The successful development of telephone-based CBT will contribute to solving a major service-delivery problem and help improve the lives of many trauma survivors who otherwise may remain without adequate and timely care. The results of this work will be easily transferrable to web-based voice- or image communication and thus become available in war and disaster zones in the future. However, telephone communication is more widely available at this point, and its use in the proposed study will better represents those who need help.