Trauma-sensitive yoga for female Veterans with PTSD who experienced military sexual trauma

 描述(由申请人提供)： 目的：本项目的总体目标是最大限度地提高患有创伤后应激障碍(PTSD)的退伍军人的健康、社会功能和生活质量，她们曾经历过军中性创伤(MST)。这项随机对照试验(RCT)的具体目的是评估专门为经历过性创伤的女性设计的创伤敏感瑜伽干预措施的有效性，与黄金标准的创伤后应激障碍治疗方法--认知处理疗法--进行比较，以1)治疗创伤后应激障碍及其慢性疼痛和失眠的共病症状，2)改善社会功能和生活质量，以及3)减少与创伤后应激障碍相关的生物和心理生理反应。研究计划：这项拟议的四年随机对照试验是我们的NRI试点研究(NRI 12-417)之后的下一步，在该研究中，我们论证了招募、保留、随机化、干预实施和数据收集的可行性，包括生物和心理生理学数据。寻求治疗创伤后应激障碍的女性退伍军人报告慢性疼痛和失眠，将从亚特兰大VAMC创伤恢复计划妇女创伤计划招募。参与者(n=210)将被随机分配到创伤敏感瑜伽(每周10次)或认知处理疗法-认知(每周12次)；两种干预方案都是数据驱动的。目标招生样本规模为210人，目标最终样本为100人或更多。根据初步研究结果，我们保守地允许50%-60%的保留率。方法：资料收集：于干预后4个点收集数据，基线时间为3个月。我们将包括自我报告、临床评估以及生物和心理生理学指标作为结果衡量标准。具体结果包括创伤后应激障碍症状严重程度、慢性疼痛、失眠、社交功能、生活质量、细胞因子(IL-6、IL-10)、C反应蛋白、黑暗强化惊厥和心率变异。数据分析：基线分组之间的比较将使用t检验、Mann Whitney非参数检验和卡方检验进行。多水平混合模型(MLM)将被用来分析随着时间的推移群体之间的差异。MLM随着时间的推移调整损耗(缺失数据)，并在时间点之间应用适当的相关性结构。临床相关性：女性退伍军人经历MST和PTSD的比率令人震惊；在VHA患者样本中，这两种疾病的一贯报告患病率均为20%或更高。MST和PTSD将这些人群置于显著的身心健康症状的风险中，包括慢性疼痛、自杀和消极的健康行为。这项随机对照试验可能会提供足够的证据，支持对经历过MST的退伍军人进行一种创新的、补充的和替代的PTSD治疗。减少痛苦症状和与创伤后应激障碍相关的心理生理压力的积极效果可能会改善社会功能和生活质量，并将创伤后应激障碍在这一人群中的重大医疗后果降至最低。这种新的循证创伤后应激障碍治疗可以补充现有的循证创伤后应激障碍治疗方式。基于这项临床试验证据的这一创新干预的临床指南可以在全国范围内的退伍军人医学中心传播和实施。

 DESCRIPTION (provided by applicant): Objectives: The overall goal of this project is to maximize the health, social functioning, and quality of life of women Veterans with posttraumatic stress disorder (PTSD) who have experienced military sexual trauma (MST). The specific aims of this randomized controlled trial (RCT) are to evaluate the effectiveness of a trauma-sensitive yoga intervention designed specifically for women who experienced sexual trauma as compared to a gold-standard PTSD treatment, Cognitive Processing Therapy-Cognitive, to 1) treat PTSD and its co-morbid symptoms of chronic pain and insomnia, 2) improve social functioning and quality of life, and 3) reduce the biological and psychophysiologic responses associated with PTSD in women Veterans who experienced MST. Research Plan: This proposed four year RCT is the next step following our NRI Pilot Study (NRI 12-417) in which we demonstrated the feasibility of recruitment, retention, randomization, intervention implementation, and data collection, including biological and psychophysiological data. Women Veterans seeking treatment for PTSD who report chronic pain and insomnia will be recruited from the Atlanta VAMC Trauma Recovery Program Women's Trauma Program. Participants (n=210) will be randomly assigned to trauma-sensitive yoga (10 weekly sessions) or Cognitive Processing Therapy-Cognitive (12 weekly sessions); both intervention protocols are data-driven. The target enrollment sample size is 210, with a target final sample of 100 or more. We are conservatively allowing for 50%-60% retention, based on pilot study results. Methods: Data Collection: Data will be collected at four points, baseline through 3-months post- intervention. We will include self-report, clinical assessments and biologic and psychophysiologic markers as outcome measures. Specific outcomes include PTSD symptom severity, chronic pain, insomnia, social functioning, quality of life, cytokines (IL-6, IL-10), C- reactive protein, dark-enhanced startle, and heart rate variabiliy. Data Analysis: Comparisons between the groups at baseline will be run using t-tests, Mann Whitney non-parametric tests, and chi-square tests as appropriate. Multilevel mixed models (MLM) will be used to analyze the differences between the groups over time. MLM adjusts for attrition (missing data) over time and applies appropriate correlation structure between the time points. Clinical Relevance: Women Veterans experience MST and PTSD at alarming rates; consistently reported prevalence rates for both among VHA patient samples are 20% or more. MST and PTSD put this population at risk for significant physical and mental health symptoms, including chronic pain, suicide, and negative health behaviors. This RCT may provide sufficient evidence to support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. The positive effects of reducing distressing symptoms and PTSD-related psychophysiological stress would likely improve social functioning and quality of life and minimize the significant medical consequences of PTSD in this population. This new, evidence-based PTSD treatment could supplement existing evidence-based PTSD treatment modalities. Clinical guidelines for this innovative intervention based on evidence from this clinical trial could be disseminated to and implemented in VA Medical Centers nationwide.