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Framework for Developing and Testing Mind and Body Interventions

SP_diagram

Introduction:

The National Center for Complementary and Integrative Health (NCCIH) provides support for research on a broad spectrum of complementary health approaches, with the goal of developing scientific evidence to inform clinical decisions by the public, health care providers, and health policymakers.

Evidence from the scientific literature may provide a plausible rationale for clinical investigation of many complementary interventions. However, investigators often lack critical information about biological effects of the intervention, outcome measures, logistical feasibility, or recruitment and retention strategies needed to design a rigorous and successful efficacy or effectiveness trial. In most cases exploratory or developmental research and pilot testing is needed to address these and related issues prior to the design and initiation of large-scale clinical studies.

Multi-phase paradigms for addressing these research needs have been very well described for pharmacologic interventions, and successfully applied to the study of many dietary supplements, botanical medicines, and probiotics. The figure above provides an analogous conceptual framework for thinking about some of the unique challenges inherent in developing and testing mind and body interventions.

The purpose for this framework as it applies to NCCIH’s interest in mind and body clinical research is to:

  1. Provide a conceptual framework for NCCIH’s clinical research in the mind and body program
  2. Clearly delineate the purpose of each stage of research development and testing
  3. Help investigators align their research interests, questions, and approach with the appropriate stage of development
  4. Provide some guidance on the available or appropriate funding mechanism(s) for each stage of research.

While this framework is presented in a linear fashion, investigation can be proposed at any stage along this continuum depending on extant data, the research environment and question, the clinical population, and the investigative team, among other factors. Below, each stage (circle) of the conceptual framework is further described.