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Editorial |

Large-Scale Study Suggests Specific Indicators for Combined Cognitive Therapy and Pharmacotherapy in Major Depressive Disorder

Michael E. Thase, MD1,2,3
[+] Author Affiliations
1Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia
2Department of Psychiatry, Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania
3Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
JAMA Psychiatry. 2014;71(10):1101-1102. doi:10.1001/jamapsychiatry.2014.1524.
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The article by Hollon and colleagues1 in this issue of JAMA Psychiatry describes the main findings of one of the most important studies ever undertaken to evaluate the merits of combining psychotherapy and pharmacotherapy for treatment of major depressive disorder (MDD). This randomized clinical trial (RCT) compared the outcomes of patients who received the Beck model of cognitive therapy (CT) in combination with a flexible, algorithm-guided pharmacotherapy protocol vs those who received pharmacotherapy alone. The study is important because of the topic—MDD is one of the world’s great public health problems and the combination of psychotherapy and pharmacotherapy has long been advocated as a preferred approach to optimize outcomes—and the approach taken, a large-scale (N = 452), 3-center study with adequate power to test both main effects and possible interactions across both short-term and continuation phases of study treatment. Thus, unlike the conventional, more narrowly focused, and smaller-scale RCT, which might be delimited to comparing response rates across 8 to 16 weeks of randomized treatment, clinicians in the current study could make multiple adjustments in the treatment regimen across up to 19 months to achieve remission, and during up to 42 months of continuation therapy to prevent relapse and foster recovery.

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Blinding and Bias in Depression Trials
Posted on November 30, 2014
Douglas Berger, M.D., Ph.D.
Meguro Counseling Center, Tokyo, Japan
Conflict of Interest: None Declared

A large problem in the study by Hollon et al. is that it was not double blind--neither the subjects nor treaters were blind to the treatment(s) given. Raters were masked, but this does not make the study single blind either--single blind is defined as when subjects are blind (1). Masked raters can only record any bias coming out of the subject-treater system.

Hiding the allocation of an intervention in a clinical trial is critical for avoiding bias in a study of major depression where endpoints are subjective (2). A small amount of expectation and hope in an unblinded study with subjective endpoints may easily bias the subjects’ report of change in depressive symptoms and a large N, as in this study, may actually validate a biased outcome to “statistical significance”.

Lack of blinding may still lead to valid results where there are objective endpoints--for example death rate, MI incidence, etc.--where any treatment effect would be great vs. random error and bias (3), but small random error and bias compared with treatment effect is not the case in a depression study with subjective endpoints.

An alternative conclusion to the results of Hollon et al. could be that the milder cases of depression included more persons who did not have a depression responsive to medical intervention (4), while for those with more severe depression, there was both a pharmacologic response as well as hope and expectation in the subjects who received cognitive therapy, biasing the results to the combination therapy. We do not assert this to be true, only that it is just as possible as the conclusion that combination therapy is more effective for severe depression and that the methodology of this clinical trial is not robust enough to opine a claim of superior efficacy for combination therapy.

(1) Friedman LM, Furgerg CD, DeMets DL. Fundamentals of Clinical Trials, Third Edition. Springer; 1998 (or do an internet search for: “definition of single-blind”). 

(2) Schulz, KF, Grimes DA, Blinding in Randomised Trials: hiding who got what. The Lancet, 2002:359; 696-700. Feburary 23, 2002. 

(3) Piantadosi S. Clinical Trials: A Methodologic Perspective, 2nd ed. New York: Wiley-Interscience; 2005. 

(4) Khan A, Leventhal R, Khan SR, Brown WA. Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol. 2002;22:40-45.

Doug Berger, M.D., Ph.D. U.S. Board-Certified Psychiatrist

Tokyo, Japan

www.megurocounseling.com, www.japanpsychiatrist.com

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