Quantification of Outcome Measures for Mind Body Interventions

描述(申请人提供)：关于身心干预的研究已经确定，它们能够通过诱导放松反应(RR)来减少被感知的慢性心理压力及其症状，并提高福祉和幸福感。放松反应是一种与众所周知的战斗或逃跑/压力反应相反的协调的系统性心理生理和行为反应。然而，关于以前使用的减压结果测量的特点，包括它们的精确度、可靠性和有效性，收集条件的重要性，客观和主观测量之间的关系，以及这些结果测量在不同的心身干预下的行为，人们知之甚少。这项应用旨在通过一项为期8周的随机对照试验来解决这些问题，干预包括冥想、瑜伽和压力教育行为安慰剂三个治疗分支，受试者为正常、健康、感觉到中度至重度压力的受试者。将在基线、治疗结束和长期随访时获得一系列全面的：1)感知的心理压力、心理健康和幸福感的主观自我报告测量；2)血液样本的基因组表达测量；以及3)血液、唾液和尿液样本的生化分析。将对所有结果指标进行全面的比较统计分析，以确定它们在所有三种治疗条件下的相对精确度、可靠性和有效性以及它们之间的相关性强度。这项研究将提供有关心身医学研究方案中最可靠、准确和成本效益最高的结果指标及其最佳给药方法的新的和重要的信息。这项研究的结果还将提供关于相对较新的基因组表达结果测量的作用和潜在疗效及其与先前在心身医学中使用的结果测量的关系的新的和有价值的信息。最后，这项研究将确定纯粹基于认知RR的心身干预(冥想)和另一种包括身体成分的干预(瑜伽)之间所有这些测量的一致性，以及它们之间在这些结果测量中是否存在细微差异。

DESCRIPTION (provided by applicant): Research on mind-body interventions has established their capability for reducing perceived chronic psychological stress and its symptoms and enhancing well-being and wellness through induction of the relaxation response (RR), a coordinated, systemic psychophysiological and behavioral response that is opposite to the well-known fight-or-flight/stress response. However, there is little known about the characteristics of previously used outcome measures for stress reduction including their precision, reliability, and validity, the importance of collection conditions, the relationship between objective and subjective measures and the behavior of these outcome measures with different mind-body interventions. This application aims to address these issues with a randomized controlled trial of an 8-week intervention with three treatment arms of meditation, yoga and a stress-education behavioral placebo control in normal, healthy subjects with moderate to severe perceived stress. A comprehensive battery of: 1) subjective self-report measures of perceived psychological stress and mental health and well-being; 2) genomic expression measures from blood samples; and 3) biochemical assays from blood, saliva and urine samples will be acquired at baseline, end- treatment and long-term follow-up. All outcome measures will be subjected to comprehensive comparative statistical analyses to determine their relative precision, reliability and validity and the strength of correlations between them for all three treatment conditions. This study will provide novel and important information regarding the most reliable, accurate and cost-effective outcome measures and the optimum method of their administration in mind-body medicine research protocols. The results of this study will also provide new and valuable information on the role and potential efficacy of the relatively new genomic expression outcome measure and its relationship to previously used outcome measures in mind-body medicine. Finally, this study will determine how consistent all of these measures are between a purely cognitive RR-based mind-body intervention (meditation) and another that includes a physical component (yoga) and whether there are subtle differences between them in these outcome measures.