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

摘要: 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 the difficulty specifying ingredients, rehabilitation researchers face designing or selecting appropriate control comparison conditions test efficacy of complex treatments. Based on lessons learned a cognitive-behavioural intervention for anger self-management people traumatic brain injury (TBI) National Institutes Health (NIH)-funded TBI Clinical Trials Network, we review advantages, disadvantages applications variety interventions. We discuss controls which active withheld (no-treatment controls, waitlist placebo-analogue designs); involve naturally occurring devised usual care treatments; compare (dismantling designs, dose equivalence trials). Recommendations developing groups maximise both equipoise participant enrolment/retention discussed.