Concept: Phased Innovation Award for Mechanistic Studies To Optimize Mind and Body Interventions in NCCIH High-Priority Research Topics
Council Date: August 26, 2015
Program Director: Wen G. Chen, Ph.D.
The National Center for Complementary and Integrative Health (NCCIH, formerly the National Center for Complementary and Alternative Medicine) is committed to the rigorous investigation of promising mind and body interventions. Mind and body interventions cover a variety of procedures or techniques administered by a trained practitioner, taught by a teacher, or self-administered, which engages nonpharmacological manipulations to the mind and/or body to improve function and symptoms. These interventions are commonly used for symptom management, particularly for pain, sleep disturbance, or mental health conditions, which are commonly managed in primary care (e.g. mild-to-moderate depression, anxiety, and post-traumatic stress).
Traditionally, exploratory clinical trials of mind and body interventions involve subjects selected on the basis of clinical indications and outcomes focused on symptom reduction. Such trials, whether positive or not with respect to symptom change or functional outcomes, provide little information about how the intervention might work in relation to the underlying cause of the clinical condition or its impact on the intermediate mechanisms, and therefore provide little guidance for further research to enhance the clinical effects of the intervention. To address this need, NCCIH intends to encourage research that studies mind and body interventions in stages by incorporating mechanisms of action and developing validated methods to assess and modulate those mechanisms. Using this approach, the first stage is to demonstrate that a proposed intervention affects a hypothesized biological signature, psychological process, or mechanism of action. At this stage, the intervention is used as a probe with the immediate goal of determining whether a biological or psychological mechanism is affected by the intervention rather than attempting to demonstrate clinical efficacy. Once an association between the proposed mechanism and intervention is established, this mechanism can then be utilized in clinical studies or potentially manipulated to test its association with the therapeutic outcomes. This phased strategy to probe the mechanisms underlying mind and body interventions encourages highly innovative projects, with the recognition that such projects may entail a greater failure rate, while managing the risk by requiring a demonstration of the intervention’s association with an underlying mechanism (e.g., biological or physiological mechanism) of action in humans before moving to the next step of clinical evaluation. NCCIH views this early mechanistic exploratory phase as efficient means to allow for development of better strategies to optimize the impact of mind and body interventions.
The general concept and the plans for support of mechanistic studies of mind and body interventions was previously presented and supported at the February 2014 NCCIH (formerly known as NCCAM) advisory council. We seek a formal voting on this specific initiative at the August 2015 advisory council.
Purpose of Proposed Initiative
The goal of this funding opportunity is to support phased studies of complementary or integrative mind and body interventions in human subjects (e.g., meditation, spinal manipulation, massage, yoga, tai chi, hypnosis, acupuncture). Studies submitted in response to this FOA should propose research that will yield insights into the fundamental mechanisms of mind and body interventions with the goal of strengthening clinical research on the efficacy of these interventions, for example, by suggesting approaches to monitor the intervention or enhance its clinical effects. Intervention development can benefit from a phased approach. This solicitation encourages studies that will first attempt to uncover mechanisms (e.g., biological or physiological mechanisms) of mind and body interventions and then, in the second phase of investigation, utilize that mechanistic understanding to build validated clinical research tools and strengthen the clinical impact of these interventions.
Projects supported through this solicitation may be provided with two phases of support. The initial phase is intended to support hypothesis-driven pilot testing and assessment of the intervention’s proposed mechanisms of action. The second phase is intended to support larger scale validation and optimization of the initial findings. This initiative is not appropriate for randomized clinical trials with the primary objectives to determine efficacy or effectiveness. The ultimate goal of this initiative is to facilitate the translation of emerging basic science findings about the mechanisms of mind and body interventions to enhance the clinical benefit of these interventions.
Examples of the second phase study may include, but are not restricted to:
- Validation of the relationship(s) between the intervention-induced mechanism(s) and clinical outcome(s) in a more targeted, or a broader, or a larger population.
- Development of an approach to modify specific components of the mind and body intervention to enhance the clinical outcome.
- Development or testing a noninvasive device to modulate the hypothesized mechanism.
- Examination of potential synergy with another therapy that has been shown to affect the same presumed mechanism or process.