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The dilemma of the control condition in experience-based cognitive and behavioural treatment research 

Authors: Tessa Harta; Jesse R. Fannb; Thomas A. Novackc
Affiliations:   a Moss Rehabilitation Research Institute and Department of Rehabilitation Medicine, Jefferson Medical College, Philadelphia, PA, USA
b Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA
c Department of Rehabilitation Medicine, University of Alabama at Birmingham, AL, USA
DOI: 10.1080/09602010601082359
Publication Frequency: 6 issues per year
Published in: journal Neuropsychological Rehabilitation, Volume 18, Issue 1 January 2008 , pages 1 - 21
First Published: January 2008
Formats available: HTML (English) : PDF (English)
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Abstract

Rehabilitation using cognitive and behavioural treatment methods (i.e., experience-based interventions) faces particular challenges in improving its evidence base through rigorous studies such as randomised controlled trials (RCTs). Experience-based treatments are often complex, with multiple “active ingredients” that may be difficult to characterise. In addition to the difficulty in specifying treatment ingredients, experience-based rehabilitation researchers face challenges in designing or selecting appropriate control or comparison conditions to test the efficacy of complex treatments. Based on lessons learned in designing a cognitive-behavioural intervention for anger self-management for people with traumatic brain injury (TBI) for the National Institutes of Health (NIH)-funded TBI Clinical Trials Network, we review the advantages, disadvantages and applications of a variety of control conditions for experience-based interventions. We discuss controls in which active treatments are withheld (no-treatment controls, waitlist controls, and placebo-analogue designs); controls that involve comparison to naturally occurring or devised usual care treatments; and conditions that compare active treatments (dismantling designs, dose controls, and equivalence trials). Recommendations for selecting and developing control groups that maximise both equipoise and participant enrolment/retention are discussed.
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