Quantification of Outcome Measures for Mind Body Interventions

Massachusetts General Hospital, Boston MA

Investigators

Linked publications & trials

Abstract

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.