Breathing Meditation Intervention for Post Traumatic Stress Disorder

 描述（由申请人提供）： 创伤后应激障碍（PTSD）是由于暴露于创伤性事件而发展的病症，其特征在于对与该创伤相关的刺激的强烈生理和心理反应。PTSD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，从伊拉克和阿富汗返回的退伍军人中有13%被诊断为创伤后应激障碍。最近的报告也强调了创伤后应激障碍与自杀有关--这一事实可能解释了退伍军人中自杀行为的惊人增长。一些研究表明，冥想疗法可能有助于治疗PTSD。Sudarshan Kriya Yoga（SKY）是一种冥想技术，涉及一系列呼吸练习，并已显示出治疗PTSD的希望。有几条证据表明，这种冥想技巧为治疗PTSD提供了坚实的基础。首先，呼吸冥想技术提供了一种强大的方法来平衡PTSD中经常加剧的自主神经系统活动。其次，它们促进放松反应，对抗过度觉醒，并导致更平静的方法来应对困难和挑战。第三，可以改善睡眠质量。这在治疗创伤后应激障碍中可能很重要，因为记忆在睡眠期间通过一个被称为巩固的过程编码成长期存储。PTSD中常见的睡眠紊乱（噩梦和失眠）可能会导致记忆巩固中断。因此，改善睡眠可能会改善PTSD。 尽管有很有希望的发现，冥想还没有在退伍军人中得到充分的研究，以推荐其在治疗创伤后应激障碍中的广泛使用。这项提案的目的是检查SKY冥想疗法对具有临床显著PTSD症状的退伍军人的影响。SKY干预将与通常用于治疗患有PTSD的退伍军人的认知加工疗法（CPT）进行比较。CPT将作为"仅认知"版本（CPT-C）给予，其在治疗PTSD中有效。退伍军人将被随机分配到两组之一（SKY，CPT-C;每组n = 38），治疗将在六周内进行。将使用"非劣效性"实验设计，适用于主要 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PTSD症状将在治疗前（即，基线）、治疗结束时、治疗后1个月和治疗后12个月。将在基线和治疗结束时进行其他测量，包括自主觉醒（心率）和认知功能，包括记忆巩固。我们还将监测辍学率，因为这些在传统的创伤后应激障碍治疗计划中可能很高。基于我们在患有PTSD的退伍军人中使用SKY的初步研究和现有文献，我们预计SKY治疗后PTSD症状的严重程度将降低，这种效果在临床上不会低于CPT-C，并且脱落率不会高于CPT-C。这些发现将为SKY治疗患有PTSD的退伍军人的疗效提供强有力的证据。我们还预计，PTSD临床指标的改善将与记忆巩固的改善相关，反映了治疗后睡眠的改善。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干预措施侧重于PTSD的不同方面; SKY干预措施侧重于呼吸和放松技巧，而CPT-C则侧重于通过认知重建来修改对创伤的理解。出于这个原因，SKY干预可能对过度唤醒的退伍军人更有效（例如心率加快）。相比之下，CPT-C干预可能对具有更多认知症状的退伍军人更有效（例如，闪回，注意力困难），因为CPT-C解决了认知过程。该项目的长期目标是进行一项全面的多中心随机对照临床研究 在退伍军人中试用SKY冥想。

 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.