Quantification of Outcome Measures for Mind Body Interventions

身心干预结果测量的量化

• 批准号: 8303957
• 负责人: HERBERT BENSON
• 金额: $ 11.9万
• 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/8303957
• 关键词: AT-10; Address; Adult; Amygdaloid structure; Attention; Behavior; Behavioral; Biochemical; Biological Markers; Characteristics; Chronic stress; Clinical; Clinical Research; Cognition; Collection; Control Groups; DNA Sequence; Data; Data Collection; Development; Education; Enrollment; Funding; Future; Genomics; Grant; Health Care Costs; Human; Immunologics; Individual; Inflammatory; Institutional Review Boards; Intervention; Investigation; Link; Measurement; Measures; Meditation; Metabolic; Metagenomics; Methods; Metric; Mind-Body Intervention; Molecular Profiling; Morbidity - disease rate; National Center for Complementary and Alternative Medicine; Neurosecretory Systems; Outcome; Outcome Measure; Parents; Participant; Patient Self-Report; Peripheral; Personal Satisfaction; Protocols documentation; Psychological Stress; Psychophysiology; Randomized; Randomized Controlled Trials; Relative (related person); Relaxation; Reporting; Research; Research Personnel; Stress; Structure; Symptoms; Technology; Testing; Time; Validation; Work; Yoga; allostatic load; base; biological adaptation to stress; body-mind; cohort; cost; cost effective; fighting; follow-up; gray matter; indexing; innovation; mortality; neuroimaging; novel; prevent; programs; psychologic; psychosocial; public health relevance; relating to nervous system; response; tool

DESCRIPTION (provided by applicant): This is a competing revision of R01 AT006464-01; the original proposal was a response to RFA AT-10-001, Translational Tools for Clinical Studies of CAM Interventions. The original proposal consists of a randomized, controlled trial of meditation and yoga compared with an attention control group in stressed but otherwise healthy subjects. The central hypothesis of the original application is that changes in psychological variables will be linked to changes in genomic expression profiles and neuroendocrine and pro-inflammatory biomarkers. This revision 1) expands the biochemical outcome variables assessed and 2) includes neuroimaging outcome measures. Adding these outcome measurements will leverage the existing protocol to expand our investigation of translational tools to the allostatic load and neuroimaging realms. First, this revision proposes to include the entire battery of measures to assess allostatic load, in order to provide a more rigorous and meaningful way to assess the effect of yoga and meditation on psychosocial and physical stress. The additional allostatic load composite measure will help determine which genomic changes may be associated with decreased morbidity and mortality, an immediately meaningful association with implications for the effect of the relaxation response on stress and potential effects on health care costs. Second, this revision proposes to include neuroimaging to assess two neural biomarkers of stress reduction that are associated with participation in meditation-based stress reduction programs. The revision hypothesizes that one of these neural biomarkers (effective connectivity) will be differentially impacted by yoga and meditation, while the other (change in amygdala gray matter structure) will be common to both. The investigators have worked with NCCAM to refine and optimize the original proposed protocol in response to NCCAM input; during this time the project has been on clinical hold. The protocol is finalized, IRB approval was granted on January 31, 2011, and the clinical hold is expected to be released by NCCAM on July 15, 2011. Importantly, no grant funds for subject recruitment, data collection, or interventio provision have yet been spent. The resulting delay in starting recruitment allows for the combination of the genomic expression, self-report and biochemical measurements included in the original proposal with the neuroimaging and allostatic load measures included in this proposed revision. The original project proposed to enroll 210 participants over 3.5 years; 50 of these participants will have been enrolled by April 1, 2012 (the proposed start date of this revision); 160 individuals will be available to participate in the neuroimaging protocol. The full array of allostatic measures will be collected on all 210 participants, as collection of these measures does not incur any additional costs; we are primarily requesting funds for analysis of the allostatic load metrics and for the collection and analysis of the neuroimaging data.

描述（由申请人提供）：这是R01 AT006464-01的竞争性修订；最初的建议是对RFA AT-10-001的回应，这是CAM干预临床研究的转化工具。最初的提案由与压力但健康的受试者中的注意力控制组相比，由冥想和瑜伽的随机对照试验组成。原始应用的中心假设是，心理变量的变化将与基因组表达谱的变化以及神经内分泌和促炎生物标志物有关。此修订版1）扩展了评估的生化结果变量，2）包括神经影像学指标。添加这些结果测量将利用现有协议将我们对转化工具的调查扩展到同种异体 负载和神经成像领域。首先，此修订建议包括评估同种异体负荷的全部措施，以提供一种更严格和有意义的方法来评估瑜伽和冥想对心理社会和身体压力的影响。附加的同层负荷综合措施将有助于确定哪些基因组变化可能与发病率和死亡率降低有关，这与对放松反应对压力的影响以及对医疗保健成本的潜在影响的影响的影响是有意义的。其次，该修订建议包括神经影像学评估与参与基于冥想的压力减轻计划有关的两种降低压力的神经生物标志物。修订假设这些神经生物标志物之一（有效的连通性）将受到瑜伽和冥想的差异影响，而另一种神经生物标志物将受到瑜伽和冥想的影响（杏仁核灰质结构的变化）将是两者共有的。研究人员已与NCCAM合作，以响应NCCAM输入来完善和优化原始提出的协议。在此期间，该项目一直在临床上。该协议是最终确定的，IRB的批准是 授予2011年1月31日，预计NCCAM将于2011年7月15日发布临床保留。重要的是，尚未花费用于招募主题，数据收集或干预措施的赠款资金。启动募集的最终延迟允许将原始建议中的基因组表达，自我报告和生化测量结果与本提出的修订中包含的神经成像和同性载荷测量进行结合。最初的项目提议在3。5年内招募210名参与者；这些参与者中有50名将在2012年4月1日之前入学（此次修订的拟议开始日期）；有160个人将可以参加神经影像学方案。所有210名参与者都将收集一系列同性措施，因为这些措施的收集不会产生任何额外的费用；我们主要要求提供资金以分析同层负载指标以及收集和分析神经成像数据。