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.

This work was supported by the Traumatic Brain Injury Clinical Trials Network, Grant No. U01 HD042738, sponsored by the National Center for Medical Rehabilitation Research, National Institutes of Health (National Institute of Child Health and Human Development) and the Neuro-Cognitive Rehabilitation Research Network, Grant No. R24 HD050836, sponsored by the National Institutes of Health (National Institute of Child Health and Human Development). We thank Nancy Temkin, PhD, Emilia Bagiella, PhD and William Friedewald, MD for helpful comments on the manuscript, and Alison Sattler for assistance with manuscript preparation.