Objective 2: Advance Research on the Whole Person and on the Integration of Complementary and Conventional Care

Over the years, much of the NCCIH research portfolio has evolved to become somewhat homogeneous⁠–⁠for example, research on meditation, mindfulness, and yoga, all of which remain important. However, exciting opportunities are emerging to carefully explore new paths toward whole person research. This will require both fundamental science and methods development using a range of approaches to address multiple aspects of a person or animal model. Mechanistic research may, as appropriate, study the impact of single or multicomponent interventions (experimental input or independent variables) on single or multisystem outcomes (output or dependent variables). Rigorous methods (e.g., factorial designs, principal component analyses) will be needed to support these variably complex study designs. The use of artificial intelligence to analyze multidimensional datasets offers exciting new opportunities that can be applied to whole person research, including identifying temporal changes in multisystem physiological patterns and defining the phenotypes of individuals more or less likely to respond to a treatment.

A comprehensive program in whole person research can collectively support a balance of analytical and synthetic approaches to elucidate individual mechanisms and understand how these mechanisms interact.

NCCIH hopes to expand research on integrated multicomponent therapies. One challenge in clinical research on complex interventions is that researchers may want to tailor the interventions to specific populations, study individual components, or change the intervention to make it more convenient, but these modifications may make replication difficult and reduce the effect size of the intervention. It is important to have a reproducible intervention or algorithm of care that can be consistently delivered by different clinicians at different sites to conduct multisite trials to assess efficacy or effectiveness of the multicomponent intervention. Another challenge is how to power a study for multiple primary outcomes. NCCIH is also interested in the development of innovative strategies to evaluate multiple outcomes in a single trial.

NCCIH-supported research has demonstrated that mind and body therapies are effective at improving symptoms in conditions such as pain and anxiety. While these therapies have shown promise, the efficacy of any single-modality treatment is typically modest, and finding a way to enhance the effect size of clinical outcomes is a crucially important goal. Multicomponent strategies may enhance the benefit to individuals by simultaneously targeting multiple pathways and may be more effective than a treatment used in isolation. It is also important to study multicomponent interventions that combine conventional and complementary approaches.

There is a fundamental lack of translational research on the mechanisms of resilience and health restoration in humans. In particular, the mechanisms of nutritional, psychological, and physical interventions in restoring health after an acute illness or recovery from a chronic condition are an understudied area that needs a multisystem approach to identify mechanisms and predictive biomarkers that could be used to optimize their effects. NCCIH seeks to support research that could expand the mechanistic and evidence base on complementary health approaches for preventing mental, emotional, and behavioral disorders and for promoting psychological and physical health, resilience, and health restoration.

NCCIH is particularly interested in studies on the efficacy and effectiveness of complementary and integrative health approaches aimed at managing pain, anxiety, and depression. The Center has invested in pragmatic research to study pain management.

Many research organizations, including NIH, support learning health care systems in which research is embedded into the delivery of care. In this type of system, data are collected every time a patient receives care, and over time, the system “learns” whether and how well the care worked. Whenever something is learned with this approach, it can be quickly applied and adopted.

Embedded pragmatic trials within a health care system are often challenging. Research and patient care have long been conceptualized as separate activities that take place in different locations under different types of oversight, and the types of recordkeeping used in clinical care, including electronic health records, may not always meet research needs. However, these challenges are beginning to be overcome, and innovative approaches continue to be developed allowing for informative research to be conducted in the actual settings where integrative health care is practiced. These approaches include pragmatic trials that employ rigorous experimental designs.

Given the widespread use of complementary health approaches, opportunities exist to employ clinical outcomes and effectiveness research methodologies to collect real-world evidence about the use of specific complementary approaches for health care, health promotion, resilience, and health restoration. This can include identifying the basic elements of health care systems that optimally support the implementation of a patient-centered, multicomponent approach to health care delivery. Pursuing this type of research requires creative collaboration with those who provide care in settings where integration of complementary health approaches could be studied. The real-world settings for such research could be quite varied, and may include schools, nursing homes, hospices, safety net clinics, Federally Qualified Health Centers, cancer treatment facilities, and settings that provide care for military personnel and veterans. NCCIH is continuing to build on initiatives such as the NIH Health Care Systems Research Collaboratory and the NIH–U.S. Department of Defense (DoD)–U.S. Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC).