Quantification of Outcome Measures for Mind Body Interventions

描述（由申请人提供）：关于身心干预的研究已经确定了他们通过诱导放松反应（RR）来减少感知的慢性心理压力及其症状并增强幸福感和健康的能力，这是一种协调的、系统的心理生理和行为反应，与众所周知的战斗或逃跑/压力反应相反。然而，很少有人知道的特点，以前使用的结果测量的压力减轻，包括其精度，可靠性和有效性，收集条件的重要性，客观和主观的措施和这些结果的行为与不同的身心干预措施之间的关系。本申请旨在通过一项为期8周的随机对照试验来解决这些问题，该试验采用冥想，瑜伽和压力教育行为安慰剂对照三种治疗方法，在具有中度至重度感知压力的正常健康受试者中进行干预。全面的电池：1）感知心理压力和心理健康和幸福的主观自我报告测量; 2）来自血液样品的基因组表达测量;和3）来自血液、唾液和尿液样品的生化测定将在基线、治疗结束和长期随访时获得。将对所有结局指标进行综合比较统计分析，以确定其相对精度、可靠性和有效性以及所有三种治疗条件下它们之间的相关性强度。这项研究将提供新的和重要的信息，最可靠的，准确的和具有成本效益的结果的措施和最佳的管理方法，在心身医学研究协议。这项研究的结果还将提供新的和有价值的信息的作用和潜在的疗效相对较新的基因组表达结果的措施，其关系到以前使用的结果措施在身心医学。最后，这项研究将确定所有这些措施之间的一致性是一个纯粹的认知RR为基础的身心干预（冥想）和另一个包括身体成分（瑜伽），以及是否有微妙的差异，他们在这些结果的措施。 公共卫生相关性：本研究的目的是提供新的信息的相对精度，心理自我报告，生化和基因组结果的身心干预措施的有效性和可靠性，以及它们之间的相关性的强度。这些信息将是重要的，以确定最可靠的，准确的和具有成本效益的结果的措施，并在未来的身心医学研究协议的最佳管理方法。因此，这将有助于加强未来身心干预研究的质量和有效性，这些研究既有效又具有成本效益，可用于预防和治疗医疗和心理疾病。

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. PUBLIC HEALTH RELEVANCE: This study aims to provide novel information on the relative precision, reliability and validity of psychological self-report, biochemical and genomic outcome measures for mind body interventions, and on the strength of correlations between them. This information will be important for the determination of the most reliable, accurate and cost-effective outcome measures and the optimum method of their administration in future mind body medicine research protocols. This will therefore serve to strengthen the quality and validity of future research studies of mind body interventions, which are both efficacious and cost-effective, for both prevention and treatment of medical and psychological conditions.