Strategic Objective 1
Advance Research on Mind and Body Interventions, Practices, and Disciplines
On this page:
- Research Challenges and Needs
The term CAM includes a large and diverse group of interventions, practices, and disciplines that are based in physical procedures or techniques administered or taught to others by a trained practitioner or teacher. They are used to improve health and well-being and in the treatment of illness or symptoms such as chronic pain or stress.
These interventions, practices, and disciplines are grouped together in this plan as mind and body* approaches because, from a research perspective, they all share a set of characteristics that create similar challenges in designing rigorous and definitive clinical investigations of their benefit and safety. For example, (1) it is generally difficult or impossible to mask practitioners and/or participants involved in clinical research, (2) claims about benefit often relate to subjective clinical outcomes, (3) in practice, the interventions are often individualized, or they are complicated procedures that are difficult to systematize or characterize fully, and (4) means to objectively measure the impact of the interventions on important biological processes are frequently lacking, particularly those that purport to act through processes not understood or well characterized by modern science.
The public’s interest in at least some of these approaches is growing. For example, NHIS data show a significant increase between 2002 and 2007 in the use of mind and body approaches such as controlled breathing practices, meditation, massage therapy, and yoga. There is also great interest across many health care disciplines regarding the potential application of some mind and body approaches to a variety of challenging health problems and to health promotion. In large part this interest is based on emerging evidence from research carried out over the past decade. For example, a large body of clinical research evidence now suggests that practices such as meditation and yoga can enhance quality of life, reduce psychological stress, and improve some mental health outcomes. At the same time, a growing body of basic research evidence suggests that mindfulness and other meditation practices engage neurobiological mechanisms known to be involved in cognition, emotion regulation, and behavior. In addition, mainstream clinical practice guidelines include evidence-based recommendations that spinal manipulation, acupuncture, and massage be considered for some patients with chronic back pain.
* Terminology: As used in this plan, mind and body encompasses interventions from the three domains of mind/body medicine, manipulative and body-based practices, and energy medicine.
Examples of CAM Mind and Body Interventions
- Breath practices
- Guided imagery
- Progressive relaxation
- Tai chi
- Spinal manipulation
- Massage therapy
- Feldenkrais method
- Alexander technique
- Trager psychophysical integration
- Healing touch
- Qi gong
- Craniosacral therapy
Specific and Nonspecific Outcomes
Many of the challenges of studying mind and body interventions are illustrated in the current state of research on acupuncture. Centuries of experience suggesting that acupuncture can be helpful in treating pain have stimulated considerable interest in scientific investigation of this ancient treatment, even though traditional teachings based on meridians and the flow of “qi” are difficult to reconcile with contemporary understanding of anatomy and neurophysiology.
The accumulated data from many clinical trials in a variety of pain conditions present a complicated picture. In efficacy-design trials where comparison has been made between “real” acupuncture and a “sham” treatment designed to be subjectively identical, differences have generally been small and not statistically significant. On the other hand, in effectiveness-design trials for a variety of conditions where acupuncture has been compared to standard care, acupuncture generally produces superior pain relief. For example, results from a series of large randomized trials supported by the German government comparing “real” and “sham” acupuncture show minimal differences in relief of pain from osteoarthritis and low-back pain. However, acupuncture plus standard care (following clinical practice guidelines) was found to yield a statistically significant and clinically meaningful superiority to standard care alone.
Thus, the current body of efficacy research provides little clinical evidence for specific effects of “real” acupuncture. At the same time the observation of substantial pain relief in effectiveness-design studies cannot be dismissed.
Research is warranted to better understand (1) the specific and the nonspecific effects involved and (2) whether either or both can be better and more intentionally employed to improve upon current strategies for treating pain. Finally, future clinical research on acupuncture must be carefully designed to ensure that controls are optimally suited for the research question being addressed.
Research Challenges and Needs
Investigators studying mind and body interventions face a number of scientifically interesting and important challenges. Foremost among them is the need to carefully define the most important research questions to be addressed, to choose appropriate experimental controls and study designs to address these questions, and to determine and validate key study design features such as the optimal frequency or duration of the intervention to be studied and measures of effect and outcome.
For example, if the research questions in a clinical trial focus on refining technique or determining a mechanism of action, incorporating a sham intervention in the study may be most appropriate. Alternatively, in cases where the most compelling and clinically relevant questions center on whether or how the intervention adds value to existing approaches (e.g., in managing a chronic symptom), an effectiveness design that entails comparison with a different treatment (rather than with a sham/placebo intervention) may be most appropriate.
Better understanding of the contributions of both specific and nonspecific effects influencing outcomes and the potential for insight into exploitation of either or both to improve symptom management or general health and well-being is needed.
For some mind and body approaches the most pressing research questions require basic or translational research aimed at developing methods or establishing amenability to scientific investigation. For example, traditional explanations for the mechanisms of action of some mind and body approaches involve processes that are not well characterized or even understood from a scientific perspective. In such cases, inability to measure objectively either the intervention itself or its effects on physiological processes is prohibitive to the design of rigorous and reproducible clinical studies. Developing such measures is therefore a more immediate research priority than efficacy studies.
For many mind and body approaches, challenges in designing and executing rigorous studies of mind and body approaches relate to the fact that most involve physical activity or procedures, or they are administered or practiced over extended periods of time, or their use in the real world is highly individualized. It is also often the case that true masking of study participants involved in a procedure (e.g., in a study of massage or meditation) is a practical impossibility. These and other problems have been encountered in other fields of biomedical research, and lessons learned in those contexts can provide important guideposts toward creative clinical research methodology.
Finally, recent research has documented the importance of contextual or nonspecific effects in the encounter between health care practitioners and their patients or clients. For example, communication on the part of the practitioner of empathy or the possibility of a positive outcome and duration of interaction can influence clinical outcomes, independent of the specific effects of interventions that the practitioner may employ. A number of mind and body interventions involve encounters between a health care provider and a patient or client in which these and other nonspecific contextual factors, expectancy, or the placebo response may contribute importantly to outcomes—particularly those involving subjective or patient-oriented benefits. Indeed, many CAM and integrative medicine practitioners intentionally seek to employ these effects to improve outcomes. Better understanding of the contributions of both specific and nonspecific effects influencing outcomes and the potential for insight into exploitation of either or both to improve symptom management or general health and well-being is needed.
Emerging evidence of promising clinical effects of many mind and body approaches points toward important opportunities to advance the science and practice of symptom management and of health promotion. In many cases the evidence is strengthened by an intriguing and growing body of basic and clinical research employing the tools and technology of the fields of neuroscience, psychoneuroimmunology, psychology, behavioral medicine, physical medicine, and biomechanics. Addressing the scientific and operational challenges confronting the study of promising mind and body interventions requires continued efforts to foster multidisciplinary collaboration that aims to engage the expertise and experience of CAM practitioners and the tools and technologies of a variety of scientific disciplines.
Understanding the Engagement of Major Pathways of Emotion Regulation by Meditative Practices
Clinical and laboratory studies of mindfulness meditation are yielding a growing body of evidence that meditation affects the mind, the brain, the body, and behavior in ways that have potential to treat many health problems and to promote healthy behavior.
For example, recent research suggests that systematic mindfulness training and other meditation practices influence areas of the brain involved in regulating awareness, attention, and emotion. Brain-imaging studies suggest that more mindful people may be better able to regulate emotional reactions or have improved self-awareness. Other research suggests that mindfulness training is associated with changes in the physical structure of the brain. Several studies suggest that meditative practices can positively affect immune function. Many of the beneficial physical effects of mindfulness training could be attributable to learning how to cope better with stress.
Ongoing NIH-supported research is investigating the use of mindfulness training in treating specific pain conditions, overeating and obesity, irritable bowel syndrome, insomnia, myocardial ischemia, and substance abuse. Mindfulness meditation is also being explored as a means of facilitating and sustaining healthy behavior change, such as smoking cessation and healthier eating habits.
Strategy 1.1: Harness state-of-the-art technologies and approaches of the neurobiological, biomechanical, behavioral, and biological sciences to:
Developing insight into biological and physiological effects and mechanisms of action of mind and body interventions is critically important in developing translational research tools and designing and executing maximally informative clinical research. It also is a crucial component of the scientific evidence base guiding clinical practice and public use and has significant potential to inform other fields of biomedical research.
Rigorous study of all clinical interventions requires well-established methodology that has undergone careful preliminary assessment and feasibility testing.
Strategy 1.2: Support translational research to build a solid biological foundation for studies of efficacy or effectiveness of mind and body interventions or disciplines.
Rigorous study of all clinical interventions requires well-established methodology that has undergone careful preliminary assessment and feasibility testing. Large clinical studies are an essential component of the evidence base regarding clinical efficacy or effectiveness. To implement such studies, treatment algorithms must be developed and validated and feasibility of accrual must be established. Methods need to be in place to measure consistency and fidelity of protocol implementation, control for practitioner variability, and monitor adherence of participants. In addition, well-characterized and meaningful clinical and laboratory outcome measures are needed to accurately assess the scope and magnitude of effects or to definitively discern a lack thereof.
Investing in development of good translational tools is essential. This investment will increase the quality and quantity of evidence garnered from large-scale clinical research, and it will help ensure that clear conclusions can be drawn from the outcomes observed. It will also augment abilities to compare results across different studies, which is essential in building a clinically useful evidence base.
Mind and Body Translational Research Needs: Selected Examples
- Developing and validating methods to assess and document interactions between providers and patients/clients so consistency can be measured or interventions reproducibly applied to other populations
- Developing and validating better objective outcome measures relevant to particular CAM interventions
- Developing and validating better measures of subjective outcomes
- Studying nonspecific contextual factors important in the interaction between CAM professionals and their patients or clients
- Defining the optimal frequency or duration of a particular CAM intervention for study in subsequent, more definitive clinical trials
- Assessing feasibility and accrual potential—e.g., implementing a particular treatment algorithm; determining the ability to recruit sufficient participants
Decisions regarding clinical research design—for example, whether to use a sham or “other treatment” control—should follow from the research question being addressed.
Strategy 1.3: Support clinical evaluation and intervention studies of mind and body interventions.
In studying this set of CAM interventions, it is particularly important that the research questions most relevant to advancing health and well-being are carefully defined and clearly articulated. Major decisions regarding clinical research design-for example, whether to use a sham or “other treatment” control-should follow from this question.
It is also critical to understand a number of considerations related to the specific population under study. Is there a standard of care or an accepted treatment for the disease or condition? What would study participants be willing to accept (e.g., treatment burden, random assignment), and how does that affect the likelihood of completing the study? How might factors such as expectancy influence responsiveness or outcomes to the intervention? Is the CAM use intended to treat conditions (e.g., pain, infection, sleeplessness), change behavior (e.g., support smoking cessation, improve medication adherence), promote overall health (e.g., healthy behavior and lifestyle modification), or a combination of these goals?
Very importantly, this work calls for creative clinical research designs and approaches that draw on the experience of other fields of biomedical and behavioral research studying procedural interventions (e.g., surgery), behavior change (e.g., cognitive-behavioral therapy), or outcomes of health interventions in real world or practice-based populations
Better Strategies for Managing Back Pain
By any measure, low-back pain is a huge public health problem. It affects approximately 25 percent of adults. While acute back pain usually resolves completely within weeks, pain becomes a chronic problem in 10 to 15 percent of cases. Costs associated with back and neck pain account for a large proportion of, and are increasing more rapidly than, overall health care expenditures.
Individuals searching for relief from chronic back pain pursue many treatment options, including opioids, injections, surgery, physical therapy, spinal manipulation, yoga, exercise therapy, acupuncture, massage, and cognitive-behavioral therapy. Often patients try different approaches, sometimes in consultation with a provider and sometimes on their own, as they search for helpful strategies. Chronic back pain is, by far, the most frequent health problem for which Americans turn to CAM. While data suggest that some interventions, both conventional and CAM, help some individuals, there is broad agreement among health care providers that none are fully satisfactory.
There is an emerging consensus that developing improved strategies for managing chronic back pain will require fresh thinking informed by:
- A better understanding of natural history and prognostic factors
- Improved diagnostic criteria and tools
- Application of state-of-the-art technologies to better elucidate biomechanics, central nervous system responses, emotional and cognitive influences, behavior, and genetics
- Pragmatic trials and outcomes research.