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）：关于思维身体干预措施的研究已经确定了通过诱导放松反应（RR）（一种协调的，系统性的心理生理学和行为反应，与知名的战斗机抗压/压力响应相反，可以减少感知到的慢性心理压力及其症状及其症状，并增强幸福感和健康的能力。但是，对以前使用的减轻压力的结果指标的特征鲜为人知，包括其精度，可靠性和有效性，收集条件的重要性，客观和主观度量之间的关系以及通过不同的身心干预的这些结果度量的行为。该应用旨在通过一项为期8周的干预措施的随机对照试验解决这些问题，并在正常，健康的受试者中具有冥想，瑜伽和压力教育的行为安慰剂控制。全面的电池：1）对心理压力，心理健康和福祉的主观自我报告措施； 2）来自血液样本的基因组表达度量； 3）将在基线，终止治疗和长期随访中获取血液，唾液和尿液样品的生化测定。所有结果措施将进行全面的比较统计分析，以确定其相对的精度，可靠性和有效性以及在所有三种治疗条件下它们之间的相关性。这项研究将提供有关最可靠，准确和成本效益的结果指标的新颖和重要信息，以及其在思维医学研究方案中的最佳方法。这项研究的结果还将提供有关相对较新的基因组表达结果指标的作用和潜在功效的新的和有价值的信息，及其与以前使用的成果指标的关系中的关系。最后，这项研究将确定所有这些措施在纯粹的认知RR思维方式干预（冥想）之间以及包括物理成分（瑜伽）的另一个措施之间的一致性以及在这些结果度量中是否存在微妙的差异。 公共卫生相关性：本研究旨在提供有关心理自我报告，生化和基因组成果的相对精确，可靠性和有效性的新信息，以进行身体干预以及它们之间的相关性。这些信息对于确定最可靠，准确和成本效益的结果指标以及其在未来的Mind Mindus Medicine研究方案中的最佳方法至关重要。因此，这将有助于增强心智干预的未来研究研究的质量和有效性，这些研究既有效又具有成本效益，既可以预防和治疗医学和心理状况。