Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group

Abstract

This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions.

ACKNOWLEDGMENTS

The authors wish to thank the study interventionists (Fredda Jaffe, Dr. Janyce Vick) and staff at the University of Washington Northwest Research Group on Aging (Amy Moore, Cathy Blackburn, Martha Cagley, Felicia Fleming, June van Leynseele, Kendra Wight, and Raquelle Williams) and Group Health Research Institute (Kathleen Saunders, Megan Addis, Shirley Meyer, and Patricia Yarbro) for their invaluable assistance in conducting this study.

FUNDING

This study was supported by Public Health Service grant R01-AG031126.

Additional information

Funding

This study was supported by Public Health Service grant R01-AG031126.