The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of promising mind and body interventions. These mind and body approaches are widely used by the public, and they are increasingly recognized to provide a non-pharmacological approach to symptom management (e.g., chronic pain, mild depression, anxiety, etc.). These approaches can be utilized by individuals to help prevent, treat, or self-manage various conditions (e.g., stress, musculoskeletal pain, headache, promote wellness), as well as being complementary to treatment offered by conventional health care. For the purposes of the current funding opportunity announcement (FOA), mind and body interventions include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), or a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR).
There is a need for research to evaluate mind and body approaches as they are used and delivered to determine whether they are safe and efficacious/effective for given conditions/disorders. For clinical trials to address this need they must be well designed and test hypotheses that will guide decisions about the inclusion of a given intervention/approach into the delivery of health care for a given condition or disorder. To that end, it is typically necessary to conduct a series of early-phase clinical trials to gather the multiple types of preliminary data needed to design subsequent large and rigorous efficacy or effectiveness studies. Although the scientific literature may provide the rationale for conducting an efficacy or effectiveness trial, investigators often lack critical information about key variables needed to implement such a trial. Some key aspects that may need further investigation to plan the future trial could include finalizing the intervention delivery method, the outcome(s), or recruitment strategy necessary to design an efficacy or effectiveness trial. Early phase clinical trials can fill this information gap, thereby improving study design and knowledge of trial feasibility. Later phase trials can go further by exploring, developing, and testing adaptive interventions; optimizing an intervention to have a greater impact on the potential mechanism of action; assessing whether the intervention can be delivered with fidelity across sites in preparation for a future multi-site trial; or determining the optimal duration or frequency of the intervention to be used in the future multi-site trial.
For more information about what NCCIH recommends for the multi-staged process for mind and body intervention development and testing, see the NCCIH website (http://NCCIH.nih.gov/grants/mindbody/stages).
Considerations for Selection of Study Design
For mind and body interventions that either are or can be delivered in groups, investigators must have a strong rationale for the choice among trial designs options. The selection of study design should be guided by decisions about how best to deliver the intervention and by concerns regarding contamination and logistics.
In traditional randomized clinical trials (RCTs), individual participants are randomized to receive an intervention that is delivered individually (e.g. spinal manipulation, acupuncture, or individually delivered hypnosis). When an intervention can be delivered in a group format there are several methods of randomizing participants to the intervention. The first option is an individually randomized group treatment trial (IRGTs), where individual participants are randomized to one of the interventions but the intervention is delivered in small groups (e.g. yoga, Mindfulness Based Stress Reduction, or tai chi classes). The second option is a group-randomized trial (GRTs), also called cluster-randomized trial (cRCTs), where groups of participants are randomized to study conditions, often defined by their workplace, school, primary care provider, or community. In cRCTs, the intervention provided to the randomized groups can be delivered individually, in small groups, or to the entire group.
The study team biostatistician will need to consider how the chosen study design led to the proposed data analysis and sample size estimates. The justification should include discussion of the positive intraclass correlation expected in data obtained from participants in the same groups, or clusters (IRGT cRCT, or GRT). In general, these types of studies need to consider how the data analysis and sample size address the extra variation expected in the data and the degrees of freedom available to estimate that extra variation. Failure to account for this variable in the sample size calculation can result in underpowered studies.
- New Applications: June 2, 2017; October 3, 2017; February 2, 2018; June 1, 2018; October 3, 2018; February 1, 2019; May 31, 2019; October 3, 2019; and January 31, 2020
- Resubmission, Revision, and Renewal Applications: October 18, 2017, February 20, 2018, June 14, 2018, October 17, 2018, February 15, 2019, June 14, 2019, October 17, 2019, February 14, 2020
- Letters of intent are due 30 days prior
Filed Under: Funding Opportunities