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

描述(由申请人提供)：拟议工作的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)，并评估其在预防创伤后应激障碍(PTSD)方面的效果。创伤后应激障碍是常见的、致残的和治疗耐药的疾病。目前的证据支持面对面创伤为重点的认知行为疗法(CBT)在预防创伤后应激障碍方面的有效性。然而，所需的临床资源有限，特别是在受战争、恐怖或灾害影响的地区。寻找通过远程电信交付CBT的方法是当务之急。基于电话的CBT已经成功地用于焦虑和情绪障碍。对受到威胁的人群的研究表明，电话支持服务被广泛使用。拟议的工作将使现有的CBT方案适用于基于电话的交付，预先测试干预的初步版本的一致性、可行性和接受性；开发高级版本并在大型随机对照试验(RCT)中对其进行评估。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名幸存者并制定干预手册。知名顾问将参与设计干预措施并监测其执行情况。对于随机对照试验，我们将从综合医院急诊室创伤登记中筛选1500名创伤事件幸存者，将前200名患有急性应激障碍(ASD)或急性PTSD的患者随机分为ET-CBT(n=100)和未治疗(n=100)，在创伤事件发生后一个月内为前者提供ET-CBT，并在三个月时比较两组。三个月后患有创伤后应激障碍的幸存者将接受面对面的CBT。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无效的人进行面对面CBT的有益影响。这项建议是以题为“暴力和创伤的精神健康后果(PA PAR-07-315)”的R34机制为蓝本的，该机制鼓励发展新的或经调整的干预措施。它针对医学研究所(IOM)2007年的建议，即“促进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交付问题，并为预防创伤后应激障碍提供一个新的工具。它将使战争和受灾地区的幸存者能够得到及时的治疗。拟议的干预措施可以很容易地转换为基于网络的语音和图像通信工具，可供越来越多的人口使用。 公共卫生相关性：创伤后应激障碍(PTSD)是一种慢性、致残的疾病，在退伍军人和恐怖、灾难和事故的幸存者中经常发生。早期的短期心理干预，称为认知行为疗法(CBT)，在许多情况下有效地预防了创伤后应激障碍。然而，CBT价格昂贵，在灾害和战争多发地区很少使用。受威胁人口广泛使用电话支持服务。基于电话的CBT对其他焦虑和情绪障碍有效。这项拟议的工作将开发基于电话的CBT，并测试其在最近出现早期PTSD症状的创伤幸存者中预防慢性PTSD的能力。基于电话的CBT的成功开发将有助于解决一个主要的服务提供问题，并有助于改善许多创伤幸存者的生活，否则他们可能仍然得不到适当和及时的护理。这项工作的成果将很容易转移到基于网络的语音或图像通信，从而在未来的战争和灾区可用。然而，电话交流在这一点上更加普遍，在拟议的研究中使用电话将更好地代表那些需要帮助的人。

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.