īecause control group design continues to be a challenge for researchers, the purpose of this paper is to provide perspectives on important considerations and make recommendations about control group design in mind-body therapy research.
Although guidelines have been proposed for the development of yoga and tai chi interventions for randomized trials and recommendations have been made about the appropriate reporting of research findings, one important methodological dilemma that has remained largely unexplored in the literature is the issue of appropriate control group design. However, numerous methodological issues have been cited in research in this area, such as a lack of consistency between research question and design, unclear treatment protocols and reporting of findings, and lack of appropriate bias controls, among others (for additional perspectives on general methodological challenges with various mind-body modalities, see ). It is relevant and important to test these interventions with appropriately designed randomized controlled trials (RCTs). Yoga and tai chi are two mind-body therapies that hold promise as complementary therapeutic interventions for clinical conditions such as depression. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research.Īs the state of the science progresses in the field of complementary and alternative medicine (CAM), it is imperative for researchers to develop well-designed clinical trials that clearly and systematically develop a base of evidence to support effects and efficacy of mind-body therapies. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question whether the control group addresses performance, expectation, and detection bias whether the control group is ethical, feasible, and attractive and whether the control group is designed to adequately control for nonspecific intervention effects. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups.
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