Preventing Hung Juries About Therapy Studies Donald F. Klein Columbia University ABSTRACT A series of arguments are presented that emphasize the importance of comparatively evaluating psychotherapies with appropriate pharmacotherapy and pill placebo. The lack of a pill-placebo arm has rendered moot those studies that compared pharmacotherapy directly with psychotherapy because of the lack of an internal sample defining calibration with regard to medication responsivity. The National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Program is critically discussed because this program incorporated the recommended design features but still led to substantial controversy. The inclusion of a pill-placebo arm in future therapeutic studies is most desirable. NIMH should initiate a funded program specifically for multisite, pill-placebo-controlled studies of psychotherapy, pharmacotherapy, and their combination, jointly sponsored and supervised by skilled psychopharmacologists and psychotherapists. This research is based on the National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Program Public Use Data Tape and Documentation. The NIMH Treatment of Depression Collaborative Research Program is a multisite program initiated and sponsored by the Psychosocial Treatments Research Branch, Division of Extramural Research Programs (now part of the Mood, Anxiety, and Personality Disorders Research Branch, Division of Clinical Research), NIMH. The program was funded by Cooperative Agreements with six participating sites: George Washington University (MH 33762), University of Pittsburgh (MH 33753), University of Oklahoma (MH 33760), Yale University (MH 33827), Clark Institute of Psychiatry (MH 38231), and Rush Presbyterian–St. Luke's Medical Center (MH 35017). The principal NIMH collaborators were Irene Elkin, Coordinator (now at the University of Chicago); M. Tracie Shea, Associate Coordinator (now at Brown University); John P. Docherty, (now at Nashua Brookside Hospital); and Morris B. Parloff, (now at Georgetown University). The principal investigators and project coordinators at the three participating research sites were Stuart M. Sotsky and David Glass, George Washington University; Stanley D. Imber and Paul A. Pilkonis, University of Pittsburgh; and John T. Watkins (now at the Atlanta Center for Cognitive Therapy) and William Leber, University of Oklahoma. The principal investigators and project coordinators at the three sites responsible for training therapists were as follows: Myrna Weissman (now at Columbia University), Eve Chevron, and Bruce J. Rousanville, Yale University; Brian F. Shaw (now at Toronto Hospital, University of Toronto) and T. Michael Vallis (now at Dalhousie University), Clarke Institute of Psychiatry; and Jan A. Fawcett and Phillip Epstein, Rush Presbyterian–St. Luke's Medical Center. Collaborators in the data management and data analysis aspects of the program were C. James Klett, Joseph F. Collins, and Roderic Gillis of the Veterans Administration Cooperative Studies Program, Perry Point, Maryland. I acknowledge the help of Donald Ross, Robin Garfinkel, and Michael Liebowitz. Correspondence may be addressed to Donald F. Klein, New York State Psychiatric Institute, Unit 22, Columbia University, 722 West 168th Street, New York, New York, 10032. Received: June 29, 1995 Revised: August 30, 1995 Journal of Consulting and Clinical Psychology © 1996 by the American Psychological Association February 1996 Vol. 64, No. 1, 81-87 For personal use only--not for distribution. Page 1 of 1112/13/2000http://spider.apa.org/ftdocs/ccp/1996/february/ccp64181.htmlAccepted: September 6, 1995 In this issue, Jacobson and Hollon state, "It is all too easy to fall into the trap of interpreting data selectively in the service of an a priori position" ( 1996, p. 74 ). This is certainly true. As Abelson (1995) stated: If a result of a study is contrary to prior beliefs, the strongest holders of those prior beliefs will tend to marshal various criticisms of the study's methodology, come up with alternative interpretations of the results, and spark a possibly long-lasting debate (p. 11). I hope that this discussion will help the field focus on the data and designs necessary to allow thoughtful, independent assessments of psychotherapy and pharmacotherapy efficacy. With regard to the Treatment of Depression Collaborative Research Program (TDCRP), Jacobson and Hollon summarized that "Klein was right all along," and that "differences favoring pharmacotherapy over CBT [cognitive—behavioral treatment] were consistent across measures and represented more than random fluctuations in the data" ( 1996, p. 75 ). Perhaps I should quit here but there is much more to address, so, not so fast! I remind the reader that the TDCRP study concluded as follows. Thus, there is no evidence in the major analyses that either of the psychotherapies was inferior to the standard reference treatment, at termination of treatment on measures of depressive symptoms or general functioning. These statistical analyses did not, of course, permit the inference that the psychotherapies and the standard reference treatment were "equal" in effectiveness. However, since we had satisfactory power in these analyses for detecting large effect size differences between pairs of treatment (in the total unstratified sample), it is unlikely that very large or important differences were missed. ( Elkin et al., 1989, p. 977 ) Despite Elkin et al.'s disclaimer that they were not asserting that the treatments were equal, they felt that nothing important had been missed. Therefore, as a practical matter, one could choose one treatment as well as the other. Their statement fostered the interpretation that medication and psychotherapy were equivalent for depression, as evidenced by a (still-unretracted) front page article in the New York Times ( Psychotherapy is as Good as Drug, 1986 ). It is these scientifically and socially misleading conclusions that require forthright criticism. However, it was only with the belated release of the final public access data tape by the National Institute of Mental Health (NIMH; in late 1994) that these analyses became possible. Data collection was completed in 1984. Jacobson and Hollon (1996) cite an article by Elkin et al. (1996) , that reportedly supports the views expressed in this article concerning the superiority of
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