Yoga for female veterans with PTSD symptoms and military sexual trauma exposure

描述（由申请人提供）： 目的：这项试点研究将确定在经历过军事性创伤（MST）的创伤后应激障碍（PTSD）女性退伍军人中进行创伤敏感哈他瑜伽方案研究的可行性。作为本研究的一部分，我们将描述该人群的PTSD症状特征、精神和医学共病、身体症状和功能状态。在这项研究中，我们将评估可行性的几个组成部分，包括：招募和保留，数据收集，以及干预方案的可接受性和实施。参与者的坚持和瑜伽教师的忠诚干预将作为实施可行性的组成部分进行评估。我们还将评估特定的生物标志物（细胞因子）和心理生理学标志物（黑暗增强惊吓反应和心率变异性），作为量化这种干预的有益效果的潜在手段。研究计划：这项可行性研究将使用混合方法，以评估实施创伤敏感的哈他瑜伽干预，采用纵向前测后测设计。女退伍军人将从VAMC创伤恢复计划妇女/MST计划中招募。患有创伤后应激障碍的退伍军人报告MST，慢性疼痛和睡眠障碍将提供为期10周的瑜伽干预;注意力控制支持小组将同时提供。目标样本量为40。将在干预前、第五次会议后、最后一次会议后2周和3个月收集定量数据，从而获得所有参与者的数据，共6个月。焦点小组将在这些相同的时间点以及第一次瑜伽课程后进行。研究方法：变量包括PTSD症状、精神和医学共病、身体症状特征、功能状态、慢性疼痛、睡眠障碍和生理反应，包括心理生理和炎症反应。这些将使用症状自我报告测量;临床医生管理的心理测量，例如CAPS;医疗记录数据;和诊断测量，包括腕关节活动记录、心率变异性、黑暗增强惊吓反应和炎性细胞因子。将通过焦点小组，使用名义小组程序，获得关于对干预措施的保留和可接受性的影响的数据。将根据这些焦点小组定性数据对招募过程、保留策略和干预方案进行修改。临床相关性：假设结果是有利的，这项研究将建立一个随机对照试验（RCT）的可行性，主要目的是 这表明，参加瑜伽干预的女性将显著减少创伤后应激障碍症状和疼痛，改善睡眠，减少生理压力和改善功能。这些积极的影响可能会提高生活质量（QOL），并最大限度地减少创伤后应激障碍的重大医疗后果，包括心血管和代谢疾病。更大的临床试验可能提供足够的证据来支持创新的补充或替代医学（CAM）创伤后应激障碍治疗的女性退伍军人，可以传播到全国各地的VA医疗中心的临床指南。

DESCRIPTION (provided by applicant): Objectives: This pilot study will establish the feasibility of conducting a study of a trauma- sensitive Hatha yoga protocol in female Veterans with posttraumatic stress disorder (PTSD) who experienced military sexual trauma (MST). As part of this study, we will characterize the PTSD symptom profile, psychiatric and medical co-morbidities, physical symptoms, and functional status of this population. In this study, we will evaluate several components of feasibility, including: recruitment and retention, data collection, and acceptability and implementation of the intervention protocol. Participants' adherence and yoga teachers' fidelity to the intervention will be evaluated as components of implementation feasibility. We also will evaluate specific biomarkers (cytokines) and psychophysiological markers (dark enhanced startle response and heart rate variability) as potential means of quantifying the beneficial effects of this intervention. Research Plan: This feasibility study will use mixed-methods to evaluate the implementation of a trauma-sensitive Hatha yoga intervention using a longitudinal pre-test- post-test design. Female Veterans will be recruited from a VAMC Trauma Recovery Program Women's/MST Program. Veterans with PTSD who report MST, chronic pain, and sleep disturbances will be offered the 10-week yoga intervention; an attention control support group will be offered in tandem. The target sample size is 40. Quantitative data will be collected prior to the intervention, after the fifth session, and 2 weeks and 3 months after the final session, yielding data on all participants for a total of 6 months. Focus groups will be conducted at these same time points as well as after the first yoga session. Methods: Variables include PTSD symptoms, psychiatric and medical co-morbidities, physical symptom profile, functional status, chronic pain, sleep disturbance and physiological responses, including psychophysiologic and inflammatory responses. These will be measured using symptom self-report measures; clinician administered psychological measures, e.g. CAPS; medical record data; and diagnostic measures, including wrist actigraphy, heart rate variability, dark-enhanced startle response, and inflammatory cytokines. Data regarding influences on retention and acceptability of the intervention will be obtained via focus groups, using nominal group process. Modifications to the recruitment process, retention strategies, and the intervention protocol will be made as indicated by these focus group qualitative data. Clinical Relevance: Assuming the results are favorable, this study will establish feasibility for a randomized controlled trial (RCT) with a primary aim of demonstrating that women who take part in the yoga intervention will have significantly reduced PTSD symptoms and pain, improved sleep, decreased physiological stress and improved functioning. These positive effects would likely improve quality of life (QOL) and minimize the significant medical consequences of PTSD, including cardiovascular and metabolic diseases. The larger clinical trial may provide sufficient evidence to support clinical guidelines for innovative complementary or alternative medicine (CAM) PTSD treatment for female Veterans which could be disseminated to VA Medical Centers nationwide.