Review Of Efficacy Research

In 1989, Elkin and colleagues published the first report from what would soon become one of the most influential and controversial treatment studies, the National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Program (TDCRP). This multisite study was designed to test the efficacy of CT, interpersonal therapy, and pharmacotherapy in the context of a placebo-controlled, multisite trial (Elkin et al., 1989). Initial analyses found few significant differences between treatments across multiple outcomes; however, subsequent analyses, exploring the role ofbaseline severity, found that more severely depressed patients experienced significantly better outcomes in pharmacotherapy than in CT; moreover, there were no differences between CT and placebo (Elkin et al., 1995).

The lack of significant differences between CT and placebo among more severely depressed patients was extremely influential. Treatment guidelines stipulated a highly limited role for CT in the treatment of severely depressed patients (e.g., American Psychiatric Association, 2000), stating, for instance, "Antidepressant medications should be provided for moderate to severe major depressive disorder unless ECT [electroconvulsive therapy] is planned. ... A specific, effective psychotherapy alone as an initial treatment modality may be considered for patients with mild to moderate major depressive disorder" (p. 2).

The findings of the TDCRP and their codification in treatment guidelines were not without controversy (e.g., Jacobson & Hollon, 1996). Critics questioned the implementation of CT based on both the pattern of site differences (sites with greater CT experience had better outcomes) and the comparison of TDCRP relapse rates with other published studies (TDCRP rates were notably higher). In addition, providing supervision relatively infrequently for TDCRP therapists (i.e., monthly), critics argued, was insufficient for newly trained cognitive therapists. Critics also noted that irrespective of CT's performance during acute treatment, there were no differences in longer-term outcomes, with CT performing as well as antidepressant medication (ADM) across the 18-month follow-up.

In addition, a subsequent mega-analysis compared CT and pharma-cotherapy for more severely depressed patients across pooled data from four studies, including the TDCRP, and found no differences between CT and medication for such patients (DeRubeis, Gelfand, Tang, & Simons, 1999). The impact of these data, however, has been tempered by methodological problems of the studies included. Specifically, the quality of ADM implementation has been questioned, and the role of allegiance effects has been highlighted in the trials whose outcomes favored CT (Hollon et al., 2002). Moreover, of the studies included, only the TDCRP was placebo-controlled, thus compromising the ability of the other trials to demonstrate that the samples were pharmacologically responsive and that the ADM conditions were properly implemented (e.g., Klein, 2000).

Two recent studies have addressed specifically the role of severity in the treatment of depression. First, DeRubeis et al. (2005) compared CT to ADM (paroxetine) in a two-site, placebo-controlled design with moderate to severely depressed patients. Across the two sites (University of Pennsylvania and Vanderbilt University), 240 patients were enrolled. Results across sites suggested that CT was comparable to ADM, with overall response rates of approximately 58% in both treatment groups. However, there was a significant site X treatment interaction, with ADM significantly outperforming CT at the Vanderbilt site (and CT showing a nonsignificant advantage over ADM at the University of Pennsylvania site). This was accounted for by patient and treatment quality differences between sites. Patients with comor-bid anxiety disorders showed better outcomes in ADM than in CT across sites; however, the greater number of comorbid patients enrolled at Vanderbilt contributed to the superior outcomes of ADM compared to CT at this site. Moreover, the therapists at the University of Pennsylvania site had greater expertise in CT, and their patients demonstrated better outcomes than ADM, in contrast to the less experienced therapists at Vanderbilt

(who did better over the second half of the study once they had more training and experience).

Second, our group also recently completed a placebo-controlled trial comparing CT, ADM, and stand-alone BA therapy among depressed adults (Dimidjian et al., 2006). Randomization in this study was stratified, based on depressive severity. Results indicated no significant differences among treatments for the less severely depressed patients (consistent with the TDCRP findings). Among more severely depressed patients, BA and ADM demonstrated comparable outcomes, and both were superior to CT. In fact, approximately 25% of severely depressed patients who received CT demonstrated a pattern of "extreme nonresponse" to treatment, defined as ending treatment with scores above 30 on the BDI. In contrast to the other patients who received CT, this subgroup also showed greater functional impairment and more frequent problems with primary supports groups at intake (Coffman, Martell, Dimidjian, & Hollon, 2007). Across the 2-year follow-up, BA performance was comparable to that of CT in the prevention of relapse and recurrence (Dobson et al., in preparation).

In general, the findings from our recent study underscore the potential importance of severity in considering the provision of CT. Consistent with TDCRP findings, our results suggest that the selection of particular treatment strategies is not as critical among less severely depressed patients. The lack of significant differences among treatments for patients with less severe depression in both studies suggests an important role for psychosocial treatments, such as CT, among less severely depressed patients, particularly in light of the potential side effects associated with the use of antidepressants.

Among more severely depressed patients, however, the findings are equivocal. The results highlight the possibility that the behavioral strategies in CT may be not only necessary but also sufficient ingredients for change. Although the importance of replicating our recent work cannot be overstated, these findings highlight the promise of behavioral strategies in the treatment of depression. Additionally, the findings reported by DeRubeis and colleagues (2005) highlight the importance of ensuring high therapist competence in the delivery of CT when working with more severely depressed patients.

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