Quantification of Outcome Measures for Mind Body Interventions

身心干预结果测量的量化

• 批准号: 8144828
• 负责人: HERBERT BENSON
• 金额: $ 44.16万
• 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/8144828
• 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. 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.

描述（由申请人提供）：身心干预研究已证实其能够通过诱导放松反应（RR）来减少感知的慢性心理压力及其症状，增强幸福感和健康水平，放松反应是一种协调的、系统性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，人们对以前使用的减压结果测量的特征（包括其精确度、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身心干预下的行为知之甚少。本申请旨在通过一项随机对照试验来解决这些问题，该试验对具有中度至重度感知压力的正常健康受试者进行为期 8 周的干预，包括冥想、瑜伽和压力教育行为安慰剂对照三个治疗组。全面的：1）感知心理压力以及心理健康和幸福的主观自我报告测量； 2) 血液样本的基因组表达测量； 3) 将在基线、治疗结束和长期随访时对血液、唾液和尿液样本进行生化检测。所有结果测量都将接受全面的比较统计分析，以确定其相对精度、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。这项研究将提供关于最可靠、准确和具有成本效益的结果测量及其在身心医学研究方案中的最佳管理方法的新颖且重要的信息。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功效及其与之前在身心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的身心干预（冥想）和另一种包含身体成分（瑜伽）的干预措施之间的所有这些措施的一致性，以及它们在这些结果措施中是否存在细微的差异。 公共卫生相关性：本研究旨在提供有关身心干预的心理自我报告、生化和基因组结果测量的相对精确性、可靠性和有效性的新信息，以及它们之间的相关性强度。这些信息对于确定未来身心医学研究方案中最可靠、最准确和最具成本效益的结果测量及其最佳管理方法非常重要。因此，这将有助于加强未来身心干预研究的质量和有效性，这些干预措施对于预防和治疗医学和心理疾病来说既有效又具有成本效益。