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

 描述（由申请人提供）： 目的：该项目的总体目标是最大限度地提高经历过军事性创伤（MST）的女性创伤后应激障碍（PTSD）退伍军人的健康，社会功能和生活质量。这项随机对照试验（RCT）的具体目的是评估专门为经历性创伤的女性设计的创伤敏感瑜伽干预与金标准PTSD治疗（认知加工疗法-认知）相比的有效性，以1）治疗PTSD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，3）减少经历MST的女性退伍军人与PTSD相关的生物和心理生理反应。研究计划：这项拟议的四年RCT是我们的NRI试点研究（NRI 12 - 417）的下一步，在该研究中，我们证明了招募、保留、随机化、干预实施和数据收集（包括生物学和心理生理学数据）的可行性。寻求创伤后应激障碍治疗并报告慢性疼痛和失眠的女性退伍军人将从亚特兰大VAMC创伤康复计划女性创伤计划中招募。参与者（n = 210）将被随机分配到创伤敏感瑜伽（每周10次）或认知加工治疗（每周12次）;两种干预方案都是数据驱动的。目标入组样本量为210，目标最终样本量为100或更多。根据初步研究结果，我们保守地允许保留50%-60%。方法：数据收集：数据将在四个点收集，从基线到干预后3个月.我们将包括自我报告，临床评估和生物学和心理生理学标志物作为结局指标。具体结果包括PTSD症状严重程度、慢性疼痛、失眠、社会功能、生活质量、细胞因子（IL-6、IL-10）、C反应蛋白、黑暗增强惊吓和心率变异性。数据分析：将使用t检验、Mann Whitney非参数检验和卡方检验（如适用）进行基线时组间比较。将使用多水平混合模型（MLM）分析组间随时间推移的差异。MLM随时间推移调整损耗（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：女性退伍军人的经验MST和创伤后应激障碍在惊人的速度;一致报告的患病率为VHA患者样本中的两个是20%或更多。MST和PTSD使这一人群面临严重的身心健康症状的风险，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提供足够的证据，以支持一种创新的，补充的和替代的创伤后应激障碍治疗的女性退伍军人谁经历了MST。减少痛苦症状和PTSD相关的心理生理压力的积极影响可能会改善社会功能和生活质量，并最大限度地减少PTSD在这一人群中的重大医疗后果。这种新的、基于证据的PTSD治疗可以补充现有的基于证据的PTSD治疗方式。基于本临床试验证据的这种创新干预的临床指南可以传播到全国的VA医疗中心并在其中实施。

 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.