On July 8–9, 2008, the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH) held a 2-day workshop in Bethesda, Maryland on meditation for health purposes. It was co-sponsored by the National Cancer Institute (NCI), the National Institute on Aging (NIA), the NIH Office of Behavioral and Social Sciences (OBSSR), and the Canadian Institutes of Health Research (INMHA, ICRH). The purpose of the meeting was to articulate potential goals and directions for research on the mechanisms and efficacy of meditation practices for a variety of health concerns. Experts from a range of disciplines and with a wide range of involvement in the field of meditation research were asked to critically examine the current state of science on meditation for health, and to identify existing or potential intersections and contributions from their fields to further this area of science. This group developed a set of critical questions and approaches that could better inform future research in this area.
The workshop participants highlighted the need to strengthen the evidence base regarding the mechanisms of action, and the efficacy and effectiveness of meditation for physical and mental health outcomes. It was noted that outcomes of interest would include not only the potential for the prevention of disease and modification of disease course, but also the management of symptoms and promotion of positive health and well-being. The participants also emphasized the need for greater collaboration among research teams, with a goal of improving cross-study comparability.
Specific needs and recommendations that were articulated to enhance further development of the evidence base included investigations in foundational clinical research and translational tools, treatment development studies, and a range of study designs testing efficacy.
Foundational clinical research. Foundational research to provide the basic information on which subsequent investigations of efficacy and effectiveness should be built is essential. Such foundational studies must be designed to forecast clinical relevance.
Clarify biological mechanisms and pathways by which meditative strategies may impact on health
Identify biological measures of the impact of meditation
Develop valid, standardized, unbiased, and objective measures and instruments to describe meditative interventions and assess dose effects
Develop precise criteria (processes and practices) of intervention fidelity for specific meditation practices
Develop indices of expectancy and adherence specific to investigations of meditation practices
Treatment development. Studies to develop meditation-based treatments could allow meditation strategies to be optimized for specific health conditions and populations.
Develop standardized treatment protocols for specific mental and physical health disorders to improve reproducibility, quality assurance, and cross-study comparability
Identify well-characterized patient populations for inclusion in subsequent efficacy studies
Develop strategies for monitoring and identifying potential risks and adverse effects
Studies to enhance the evidence base for efficacy. A variety of study types and designs are needed to contribute to the evidence base, ranging from retrospective and prospective observational studies to well-designed clinical efficacy investigations. Such studies must be well-controlled and focused, and will further the evidence base for potential clinical applications.
Explore opportunities to add measures and gather important descriptive data including recurrent cross-sectional studies such as large national surveys (NHANES, NHIS) and on-going cohort investigations
Ensure that studies are sufficiently powered and that the study designs are appropriate to answer the research questions
Incorporate inclusion of specific biological and psychological outcomes, with plausible mechanisms linking the specific meditative practice with relevant outcomes
Ensure outcomes are clinically significant, measurable, and linked to health importance, including short-term and long-term measures of symptom management, coping with illness, quality of life, prevention of disease, and biological indices of health and disease from multiple systems
Develop and incorporate validated and standardized measures of expectancy, treatment adherence, and treatment fidelity for cross-study comparisons. Such cross-study comparisons would be particularly powerful should there be a well-characterized participant specimen repository available for investigations conducted using standardized measures and protocols.
Include appropriate control groups that are carefully developed with a consideration of the specific question(s) to be addressed. Factors to be controlled should be specifically identified (e.g., contextual factors not relevant to the specific study hypotheses such as time, attention, built environment, etc)
Integrate masking strategies to reduce sources of bias. As with the control group design, such strategies must be developed in light of specific potential sources of bias.
Essential to the success of research to understand and assess the role of meditation for health purposes are focused, effective multidisciplinary and transdisciplinary collaborative teams that incorporate expertise in basic science including cognitive and behavioral neuroscience, translational science, contemplative practices, clinical trials development, medicine, psychology, and biostatistical and trial design strategies and tools.
Source: NCCAM, http://nccam.nih.gov/news/2008/070808.htm?nav=rss