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R 01 AT 006464 -01的竞争版本;原始提案是对RFA AT-10-001，CAM干预临床研究转化工具的回应。最初的提议包括一项随机对照试验，将冥想和瑜伽与注意力控制组进行比较，这些受试者在压力下但在其他方面健康。原始申请的中心假设是，心理变量的变化将与基因组表达谱和神经内分泌和促炎生物标志物的变化有关。该修订版1）扩展了评估的生化结局变量，2）包括神经影像学结局指标。增加这些结果测量将利用现有的协议，以扩大我们的研究翻译工具的变静态 负荷和神经成像领域。首先，该修订建议纳入评估非稳态负荷的整套措施，以便提供更严格和更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。额外的非稳态负荷复合测量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相关，这与放松反应对压力的影响和对医疗保健费用的潜在影响的直接有意义的关联。第二，这次修订建议包括神经影像学，以评估与参与基于冥想的减压计划相关的两种减压神经生物标志物。该修订假设这些神经生物标志物之一（有效连接）将受到瑜伽和冥想的不同影响，而另一个（杏仁核灰质结构的变化）将是共同的。研究者与NCCAM合作，根据NCCAM的输入，完善和优化了最初提出的方案;在此期间，该项目一直处于临床暂停状态。方案定稿，IRB批准 于2011年1月31日获得批准，预计NCCAM将于2011年7月15日发布临床搁置。重要的是，还没有用于受试者招募、数据收集或干预提供的赠款资金。由此导致的招募开始延迟允许将原始提案中包含的基因组表达、自我报告和生化测量与本拟议修订中包含的神经影像学和非稳态负荷测量相结合。原始项目计划在3.5年内招募210名受试者;其中50名受试者将在2012年4月1日（本修订的拟定开始日期）之前入组; 160名受试者将可参与神经影像学方案。将收集所有210名参与者的全部非稳态测量结果，因为收集这些测量结果不会产生任何额外费用;我们主要要求资金用于分析非稳态负荷指标以及收集和分析神经影像学数据。