Breathing Meditation Intervention for Post Traumatic Stress Disorder

 描述(由申请人提供)： 创伤后应激障碍(PTSD)是由于暴露在创伤事件中而发展起来的一种疾病，其特征是对与创伤相关的刺激产生强烈的生理和心理反应。创伤后应激障碍在退伍军人的疾病负担中占很大比例。最近的一项研究发现，从伊拉克和阿富汗归来的退伍军人中，有13%的人被诊断出患有创伤后应激障碍。最近的报告还强调，创伤后应激障碍与自杀行为有关--这一事实可能解释了回国退伍军人中自杀行为的惊人上升。几项研究表明，以冥想为基础的治疗可能对治疗创伤后应激障碍有帮助。苏达山·克莉亚瑜伽(Sky)是一种冥想技术，涉及一系列呼吸练习，在治疗创伤后应激障碍方面表现出了希望。有几条证据表明，这种冥想技术为治疗创伤后应激障碍提供了坚实的基础。首先，呼吸冥想技术为平衡自主神经系统活动提供了一种强有力的方法，这种活动在创伤后应激障碍患者中经常会增强。其次，它们促进放松反应，以对抗过度唤醒，并导致对困难和挑战采取更冷静的方法。第三，它们可能会改善睡眠质量。这在治疗创伤后应激障碍时可能很重要，因为记忆在睡眠期间通过一种称为巩固的过程被编码成长期存储。在创伤后应激障碍(噩梦和失眠)中常见的睡眠障碍可能会导致记忆巩固被打乱。因此，睡眠改善可能会导致创伤后应激障碍的改善。 尽管有了令人振奋的发现，但冥想在退伍军人中还没有得到充分的研究，无法推荐其在治疗创伤后应激障碍中的广泛使用。这项建议的目标是检查天空冥想疗法对具有临床显著创伤后应激障碍症状的退伍军人的影响。天空干预将被比作认知处理疗法(CPT)，后者通常用于治疗患有创伤后应激障碍的退伍军人。CPT将作为对治疗创伤后应激障碍有效的“纯认知”版本(CPT-C)给予。退伍军人将被随机分配到两组中的一组(Sky，CPT-C；每组38人)，治疗将在六周内进行。“非劣势”实验设计将被适当地用于试验，在该试验中， 目的是证明一种新的干预措施(SKY)与标准干预措施一样有效。患者的创伤后应激障碍症状将在治疗前(即基线)、治疗结束时、治疗后一个月和治疗后12个月进行监测。其他措施将在基线和治疗结束时采取，包括自主唤醒(心率)和认知功能，包括记忆巩固。我们还将监测辍学率，因为在传统的创伤后应激障碍治疗计划中，辍学率可能很高。根据我们在患有PTSD的退伍军人中使用SKY的初步研究和现有文献，我们预计使用SKY治疗后PTSD症状的严重程度将会减轻，这种影响不会在临床上低于CPT-C，退学率不会高于CPT-C。这些发现将为Sky治疗患有创伤后应激障碍的退伍军人的有效性提供强有力的证据。我们还预计，创伤后应激障碍临床测量的改善将与记忆巩固的改善相关，反映出治疗后睡眠的改善。个体对治疗的反应也可能受到其基线特征的影响。Sky和CBT-C干预侧重于创伤后应激障碍的不同方面；Sky干预侧重于呼吸和放松技巧，而CPT-C侧重于通过认知结构调整改变对创伤的理解。出于这个原因，天空干预对于过度唤醒(例如心率加快)的退伍军人可能更有效。相比之下，CPT-C干预对有更多认知症状(如闪回、注意力障碍)的退伍军人可能更有效，因为CPT-C涉及认知过程。该项目的长期目标是进行全功能的多中心随机对照临床试验。 退伍军人天空冥想试验。

 DESCRIPTION (provided by applicant): Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to a traumatic event and is characterized by intense physiological and psychological reactivity to stimuli associated with that trauma. PTSD represents a substantial proportion of the burden of illness among Veterans. A recent study found that PTSD was diagnosed in 13% of Veterans returning from Iraq and Afghanistan. Recent reports have also highlighted that PTSD is associated with suicidality - a fact that may explain the alarming rise of suicidal behavior amongst returning Veterans. Several studies suggest that meditation-based treatments may be helpful in treating PTSD. Sudarshan Kriya Yoga (SKY) is a meditation technique that involves a sequence of breathing exercises and has shown promise in treating PTSD. There are several lines of evidence to suggest that such meditation techniques provide a solid foundation for treating PTSD. First, breathing meditation techniques offer a powerful method for balancing autonomic nervous system activity that is often heightened in PTSD. Second, they promote the relaxation response that counters hyperarousal and results in a calmer approach to difficulties and challenges. Third, they may improve sleep quality. This may be important in treating PTSD because memories are encoded into long-term storage during sleep via a process known as consolidation. It is possible that the disturbed sleep which is common in PTSD (nightmares and insomnia) lead to disrupted memory consolidation. Therefore improvement in sleep may lead to improvement in PTSD. Despite promising findings, meditation has not been sufficiently studied in Veterans to recommend its widespread use in treating PTSD. The goal of this proposal is to examine the effects of SKY meditation therapy on Veterans with clinically significant PTSD symptoms. SKY intervention will be compared to cognitive processing therapy (CPT) that is commonly used to treat Veterans with PTSD. CPT will be given as a "cognitive only" version (CPT-C) which is efficacious in treating PTSD. Veterans will be randomly assigned to one of the two groups (SKY, CPT-C; n=38 per group) and treatment will be delivered over a six-week period. A "noninferiority" experimental design will be used as is appropriate for trials in which the primary objective is to show that a novel intervention (SKY) is as effective as the standard intervention. Patients' PTSD symptoms will be monitored across time; before treatment (i.e., baseline), at the end of treatment, one month after treatment and 12 months after treatment. Other measures will be taken at baseline and at the end of treatment, and will include autonomic arousal (heart rate) and cognitive functioning including memory consolidation. We will also monitor dropout rates as these can be high in conventional PTSD treatment programs. Based on our preliminary studies using SKY in Veterans with PTSD and the existing literature, we expect that PTSD symptom severity will be reduced following treatment with SKY, that this effect will not be clinically infeior to CPT-C and that the dropout rates will be no higher than CPT-C. Such findings would provide strong evidence for the efficacy of SKY in treating Veterans with PTSD. We also expect that improvements in clinical measures of PTSD will correlate with improvements in memory consolidation, reflecting improvements in sleep following treatment. It is also likely that the individual's response to treatment will be influenced by their baseline characteristics. The SKY and CBT-C interventions focus on different aspects of PTSD; the SKY intervention focuses on breathing and relaxation techniques whereas CPT-C focuses on modifying the understanding of trauma through cognitive restructuring. For this reason the SKY intervention may be more effective for Veterans who have exaggerated arousal (e.g. heightened heart rate). In contrast the CPT-C intervention may be more effective for Veterans who have more cognitive symptoms (e.g., flashbacks, attentional difficulties) since CPT-C addresses cognitive processes. The long term goal of this project is to conduct a fully-powered multi-center randomized controlled clinical trial of SKY meditation in Veterans.