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Randomized Controlled Trial
. 2016 Sep-Oct;14(5):514-27.
doi: 10.1080/15402002.2015.1036271. Epub 2015 Oct 20.

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

Benjamin H Balderson  1 , Susan M McCurry  2 , Michael V Vitiello  3 , Susan M Shortreed  1 , Bruce D Rybarczyk  4 , Francis J Keefe  5 , Michael Von Korff  1
Affiliations
Randomized Controlled Trial

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

Benjamin H Balderson et al. Behav Sleep Med. 2016 Sep-Oct.

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.

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