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Selecting the ‘Right’ Comparators for Meditative Movement Interventions

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April 18, 2016
Lanay M. Mudd, Ph.D.
Lanay M. Mudd, Ph.D.

Program Director, Division of Extramural Research
National Center for Complementary and Integrative Health

View Dr. Mudd's biographical sketch

In a typical work week, I talk to several potential grant applicants about their specific aims and/or research questions as they develop a grant proposal. While these conversations often center on the development of a mind-body intervention, occasionally I get asked, “What would be the best control group for this intervention?” In reality, there is no easy answer to this question.

The development of an appropriate comparator is a critical, yet often overlooked piece of designing rigorous trials of mind-body interventions. In a tutorial session at the upcoming International Congress for Integrative Medicine and Health (ICIMH), I have invited three current NCCIH Grantees, Crystal Park, Ph.D., Robert Saper, M.D., M.P.H., and Anand Dhruva, M.D., to help me delve deeper into the process of selecting comparators for meditative movement interventions (i.e., yoga, tai chi, and qi gong).

By their very nature, yoga, tai chi, and qi gong, are multi-component interventions including meditative techniques, breathing exercises and forms of physical activity. In addition, all of these interventions can provide nonspecific effects such as expectations for improvement, teacher attention, and social support. Investigators employing these therapies as a health intervention often struggle to define the mechanism of effect, which renders the selection of the most appropriate comparator group difficult.

In our session, we will:

  1. Review the process of defining the hypothesis of interest and using that hypothesis to guide the selection of a comparator group.
  2. Discuss the pros and cons of comparing separate elements of each therapy (e.g., yogic breathing vs. poses) versus examining them as a whole therapy, and the research questions these different approaches could answer. The importance of precise measurement techniques relevant to meditative movement therapies to allow for more rigorous hypothesis testing will be highlighted.
  3. Discuss NCCIH funding opportunities, such as PAR-14-182, which can be used to develop both intervention and comparator conditions.
  4. Conclude the session with interactive Q&A time where I will pose common research question scenarios to the panelists and ask them to suggest their “ideal comparator group” for that scenario.

We look forward to a lively discussion at ICIMH and hope you can join us there!

Comments

Comments are now closed for this post.

How, when, and where do I access this blog/information about “Selecting the Right Comparators”? Is it something that will be streamed live, or do I have to attend the International Congress in person? I can’t attend, so will it also be recorded and available at a later date?Thank you. 

When and where is this happening?  I am interested!

I am a senior who has practiced and been certified in Holistic Health modalities including the “Awareness through Movement” through the Feldenkrais Method.  I work with other seniors to assist them with breathing, movement and balance. My interest is to continue receiving information to enhance and further my background and offer this to others.

We have been quite involved in this space and would love to participate — provide insight or listen in. Can you give more information on how to access this session. We work with Dr Larkey and published some of the earliest papers on Meditative Movement (dynamic meditation).Most recent project is a collaboration with the Mayo Clinic, AZ State U and the Institute of Integral Qigong and Tai Chi (IIQTC);The Press Release:https://asunow.asu.edu/20151130-discoveries-healing-inside-out?utm_campaign=HUB_ASU+NOW+12-1-15&utm_medium=email&utm_source=Now%20publication%20list&utm_term=HUB&utm_content=%20https%3a%2f%2fasunow.asu.edu%2f20151130-discoveries-healing-inside-outDr Roger Jahnke, OMDhttp://IIQTC.orghttp://HealthAction.net

I think the answer to selecting the “right” comparator for meditative movement interventions (and I think this is true for all body-based interventions) involves the investigator having a hypothesis/idea/background concept for the mechanism that (s)he thinks underlies the clincial benefit of the intervention. From that as a starting point the “right” comparator/control should be designed to “not” activate/engage/enhance that mechanism. Really not radically different from the idea of a placebo pill which does not activate the pathway an investigational drug its thought to activate. Without such an approach to selecting the comparator, then even if the intervention vs the comparator produces clinical benefit, one has no useful information whether  the benefit arose from some unique or special property of the intervention or because it simply engaged a mechanim that either many-other or commonly-used  interventions can also engage, ie. one hasn’t gotten as much bang for their buck as that they could have. While a positive clinical effect for the intervention vs the “right” comparator based upon a mechanistic hypothesis/idea background concept doesn’t prove that the proposed mechanism is correct, it provides a basis for enhancing our knowledge by enabling the design of subsequent intervention studies to uniquely activate a similar proposed mechanism or by assessing whether other successful mind-body interventions could reasonably be considered to activate the same mechanism.

In my opinion, selecing an appropriate ”control group” for randomized trials on complementary (or holistic) therapies is unusally complicated due to the usually ignored conflict between two significant and opposing research paradigms (i.e., a reductionistic approach that attempts to identify the “critical or therapeutic ingredients” of an intervention versus a holistic, comprehensive approach that treats an intervention as “more than the sum of its parts” and therefore, cannot be dissected).Several authors have written papers discussing this dilemma, but it is difficult to change (or open) the minds of scientists and reviewers who have spent their entire careers influenced by scientific methods used in bench research or drug studies.  I appreciate the attempts made to address this topic!

I just heard about this presentation and will not be able to attend the conference on such short notice.  Could this session be recorded and accessed at a later date?  I really need to learn from this presentation to inform my research.

This is so important! As a mindful movement educator who works with people diagnosed with cancer, we need more information on the specific protocols that are indicated. The term “yoga” itself is so vast and encompassing, and includes so many different styles and techniques. And within the yoga community, there is much disagreement about which approach is best. It would be great to do dismantling trials as well as comparitive trials by style of yoga or techniques practiced. It is like calling all pharmaceutical interventions “medicine” and saying that medicine works. For who, how, when? Thank you so much, Dr. Mudd and staff!]

This page last modified April 25, 2016