title: The dilemma of the control condition in experience-based cognitive and behavioural treatment research.
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.
authors.affiliation: Department of Rehabilitation Medicine, Jefferson Medical College, Philadelphia, PA, USA. thart@einstein.edu
authors.forename: Tessa
authors.initials: T
authors.lastname: Hart
authors.forename: Jesse R
authors.initials: JR
authors.lastname: Fann
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Novack
mesh_terms: D000786:Anger; D001521:Behavior Therapy / Q000379:methods*; D001930:Brain Injuries / Q000150:complications / Q000523:psychology* / Q000534:rehabilitation*; D019317:Evidence-Based Medicine; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D036302:Therapeutic Human Experimentation