Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder [version 2; referees: 2 approved]

While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials. Douglas Berger ( ) Corresponding author: [email protected] Berger D. How to cite this article: Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major 2016, :638 (doi: ) Depressive Disorder [version 2; referees: 2 approved] F1000Research 4 10.12688/f1000research.6953.2 © 2016 Berger D. This is an open access article distributed under the terms of the , which Copyright: Creative Commons Attribution Licence permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) declared that no grants were involved in supporting this work. Grant information: Competing interests: No competing interests were disclosed. The author has no financial interests, activities, relationships, and affiliations other than those affiliations listed in the title page of the manuscript. There was no data collected or analyzed for this paper. 27 Aug 2015, :638 (doi: ) First published: 4 10.12688/f1000research.6953.1 Referee Status: