Quantification of Outcome Measures for Mind Body Interventions

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，CAM干预的临床研究翻译工具的回应。最初的建议包括一项随机对照试验，对压力较大但其他方面健康的受试者进行冥想和瑜伽，并与注意力控制组进行比较。最初应用的中心假设是，心理变量的变化将与基因组表达谱以及神经内分泌和促炎生物标志物的变化有关。这一修订1)扩展了评估的生化结果变量，2)包括了神经成像结果测量。添加这些结果测量将利用现有的协议将我们对翻译工具的研究扩展到异构体 负荷和神经成像领域。首先，这次修订建议包括评估静力负荷的整套措施，以便提供一种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。额外的恒定负荷综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的降低相关，这与松弛反应对压力的影响以及对医疗费用的潜在影响立即有意义的关联。其次，这项修订建议包括神经成像，以评估两个与参与基于冥想的压力减轻计划相关的压力减轻的神经生物标志物。这项修订假设，其中一个神经生物标记物(有效连接性)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)将对两者都有共同影响。研究人员与NCCAM合作改进和优化了最初提出的方案，以响应NCCAM的输入；在此期间，该项目一直被临床搁置。协议最终敲定，IRB批准 2011年1月31日批准，临床搁置预计将于2011年7月15日由NCCAM发布。重要的是，还没有用于招募受试者、收集数据或提供干预措施的赠款资金。因此推迟开始招募，可以将原提议中包括的基因组表达、自我报告和生化测量与本拟议修订本中包括的神经成像和恒定负荷措施结合起来。最初的项目建议在3.5年内招募210名参与者；其中50名参与者将在2012年4月1日(本次修订的拟议开始日期)之前招募；160名个人将可参与神经成像方案。由于收集这些措施不会产生任何额外费用，我们将收集所有210名参与者的全部非平衡措施；我们主要是为分析非平衡负荷指标以及收集和分析神经成像数据申请资金。

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.