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

描述(由申请人提供)： 目的：这项先导性研究将确定在患有创伤后应激障碍(PTSD)的退伍军人中进行创伤敏感型哈达瑜伽方案研究的可行性，这些退伍军人经历了军中性创伤(MST)。作为这项研究的一部分，我们将描述这一人群的创伤后应激障碍症状、精神和医学并存、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：招聘和保留、数据收集以及干预方案的可接受性和实施。参与者对干预的忠诚度和瑜伽教师对干预的忠诚度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记物(细胞因子)和心理生理学标记物(黑暗增强的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来评估创伤敏感型哈达瑜伽干预的实施情况，采用纵向的前测-后测设计。女性退伍军人将从VAMC创伤恢复计划妇女/MST计划中招募。患有创伤后应激障碍、慢性疼痛和睡眠障碍的退伍军人将接受为期10周的瑜伽干预；将同时提供注意力控制支持小组。目标样本量为40。将在干预之前、第五次会议之后、最后一次会议后2周和3个月收集定量数据，得出所有参与者总共6个月的数据。焦点小组将在这些相同的时间点进行，以及在第一次瑜伽课程之后进行。方法：变量包括创伤后应激障碍症状、精神和内科合并症、躯体症状、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措施；临床医生实施的心理措施，例如CAPS；医疗记录数据；以及诊断措施，包括腕部活动描记、心率变异性、黑暗增强的惊吓反应和炎症细胞因子。使用名义小组程序，通过焦点小组获得有关影响干预措施保留率和可接受性的数据。将根据这些重点小组的定性数据，对招聘程序、保留战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，改善功能。这些积极的影响可能会改善生活质量(QOL)，并最大限度地减少创伤后应激障碍的重大医疗后果，包括心血管和代谢性疾病。更大规模的临床试验可能会提供足够的证据来支持针对女性退伍军人的创新型补充或替代医学(CAM)创伤后应激障碍治疗的临床指南，该指南可以传播到全国的退伍军人医学中心。

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.