Quantification of Outcome Measures for Mind Body Interventions

身心干预结果测量的量化

• 批准号: 8541701
• 负责人: John W Denninger
• 金额: $ 67.49万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8541701
• 关键词: Address; Adult; Attention; Behavior; Behavioral; Biochemical; Biological Assay; Biological Markers; Blood; Blood specimen; Characteristics; Chronic; Chronic stress; Clinical Research; Cognition; Cognitive; Collection; DNA Sequence; Development; Education; Exhibits; Future; Genomics; Human; Immunologics; Inflammatory; Intervention; Link; Measures; Medical; Meditation; Mental Health; Metabolic; Metagenomics; Methods; Mind-Body Intervention; Molecular Profiling; Neurosecretory Systems; Outcome Measure; Patient Self-Report; Personal Satisfaction; Placebo Control; Prevention; Protocols documentation; Psychological Stress; Psychophysiology; Questionnaires; Randomized; Randomized Controlled Trials; Relative (related person); Relaxation; Research; Role; Saliva; Sampling; Stress; Symptoms; Technology; Testing; Urine; Validation; Validity and Reliability; Yoga; arm; base; biological adaptation to stress; comparative; cost effective; fighting; follow-up; innovation; interest; novel; patient population; psychologic; public health relevance; response; therapy development; tool

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.

描述（由申请人提供）：身心干预的研究已经确立了它们通过诱导放松反应（RR）来减少感知到的慢性心理压力及其症状，并增强幸福感和健康的能力，放松反应是一种协调的、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，对于以往使用的减压结果测量的特征，包括其精度、信度和效度，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身心干预下的行为，人们知之甚少。本应用程序旨在通过一项为期8周的随机对照试验来解决这些问题，其中包括冥想，瑜伽和压力教育行为安慰剂控制的三个治疗组，在正常，健康的受试者中进行中度至重度感知压力。1)主观自我报告测量感知心理压力和心理健康和福祉；2)血液样本基因组表达测定；3)在基线、治疗结束和长期随访时进行血液、唾液和尿液的生化分析。所有结果测量都将进行全面的比较统计分析，以确定它们的相对精度、可靠性和有效性，以及它们在所有三种治疗条件下的相关性强度。本研究将为身心医学研究方案中最可靠、最准确、最具成本效益的结果测量方法及其最佳管理方法提供新颖而重要的信息。本研究的结果还将提供新的和有价值的信息，关于相对较新的基因组表达结果测量的作用和潜在功效，以及它与先前使用的结果测量在身心医学中的关系。最后，本研究将确定所有这些测量在纯粹基于认知rr的身心干预（冥想）和另一个包括身体成分（瑜伽）之间的一致性，以及它们之间在这些结果测量中是否存在细微差异。