clinicaltrials.gov Identifier: NCT00970437.

<b><i>Background:</i></b> Evidence on the long-term efficacy of psychotherapeutic approaches for chronic depression is scarce. <b><i>Objective:</i></b> To evaluate the effects of the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) compared to Supportive Psychotherapy (SP) 1 year and 2 years after treatment termination. <b><i>Methods:</i></b> In this study, we present 1- and 2-year follow-up assessments of a prospective, multicenter, evaluator-blinded, randomized clinical trial of outpatients with early-onset chronic major depression (<i>n</i> = 268). The initial treatment included 32 sessions of CBASP or SP over 48 weeks. The primary outcome was the rate of “well weeks” (Longitudinal Interval Follow-Up Evaluation; no/minimal symptoms) after 1 year and 2 years. The secondary outcomes were, among others, clinician- and self-rated depressive symptoms, response/remission rates, and quality of life. <b><i>Results:</i></b> Of the 268 randomized patients, 207 (77%) participated in the follow-up. In the intention-to-treat analysis, there was no statistically significant difference between CBASP and SP patients in experiencing well weeks (CBASP: mean [SD] of 48.6 [36.9] weeks; SP: 39.0 [34.8]; rate ratio 1.26, 95% CI 0.99–1.59, <i>p</i> = 0.057, <i>d</i> = 0.18) and in remission rates (CBASP: 1 year 40%, 2 years 40.2%; SP: 1 year 28.9%, 2 years 33%) in the 2 years after treatment. Statistically significant effects were found in favor of CBASP 1 year after treatment termination regarding the rate of well weeks, self-rated depressive symptoms, and depression-related quality of life. <b><i>Conclusions:</i></b> CBASP lost its superiority over SP at some point between the first and the second year. This suggests the necessity of maintenance treatment for early-onset chronically depressed patients remitted with CBASP during the acute therapy phase, as well as the sequential integration of other treatment strategies, including medication for those who did not reach remission.

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Background: The cognitive-behavioral analysis system of psychotherapy (CBASP) was developed for the treatment of chronic, early-onset depression. However, it is unclear whether this approach can be recommended for depression in general (episodic and chronic), and no direct comparisons between CBASP with different versions of cognitive-behavioral therapy (CBT) exist. Methods: A randomized controlled trial compared 3 treatment conditions (all lasting 16 sessions) with a waiting list group (WL): CBASP, CBT with a focus on physical exercise (CBT-E), and CBT with a focus on pleasurable, low-energy and mindful activities (CBT-M). We included 173 patients and involved 41 therapists. Assessments were at baseline, after session 8, and at the end of treatment. Results: Our primary outcome Beck Depression Inventory-II indicated a general advantage of the CBT arms compared to CBASP [F(6, 154.5) = 4.2, p = 0.001], with significant contrasts in particular in favor of CBT-E. Effect sizes against WL were d = 0.91 (CBT-E), 0.87 (CBT-M), and 0.47 (CBASP). A triple interaction with an additional factor “chronic versus episodic depression” [F(6, 142.7) = 2.2, p = 0.048] indicated that the treatments resulted in different outcomes, with best results again for CBT-E in particular in episodic depression. Responder rates indicated significant improvements (56% in both CBT arms, 34% in the CBASP arm, 3.4% in WL; intention-to-treat samples). As compared to CBASP, response rates were significantly higher for CBT-E (OR = 2.48; 95% CI = 1.02–6.00) and CBT-M (OR = 2.46; 95% CI = 1.01–6.01). Conclusions: CBASP was more effective than WL, but less effective than the 2 CBT arms. This was mainly caused by an advantage of CBT interventions in episodic depression.

adult outpatients with early-onset PDD, CBASP leads to greater improvements in depression at the end of treatment [3] and 1 year later (but not beyond that) [4]. We conducted a sequential mediation analysis testing the hypothesis that the treatment effect (CBASP vs. SP) on outcome is mediated by a sequential indirect effect of treatment-specific improvements in the therapeutic relationship and a subsequent decrease in social inhibition.The inclusion and exclusion criteria of this RCT are described elsewhere [3]. Briefly, the acute-phase treatment consisted of 24 sessions of CBASP or SP over 20 weeks. In the continuation phase, 8 further sessions were administered between week 20 and 48. In CBASP, the therapeutic relationship is explicitly targeted using techniques that are collectively labeled disciplined personal involvement. For example, positive in-session experiences with the therapist are contrasted with hurtful reactions from significant others to promote safety in the therapeutic dyad (interpersonal discrimination exercise). SP calls for a far less structured approach to the therapeutic relationship and relies on the broader common factors of psychotherapy.Our analysis was performed in a modified intention-to-treat population that included all randomized patients for whom data were available for the mediating variables for at least 1 of the assessments (256 out of 268 patients, 95.5%). These mediating variables were the Helping Alliance Questionnaire (HAQ) and the Inventory of Interpersonal Problems (IIP). Outcome was measured using the clinician-rated Hamilton Rating Scale for Depression (HRSD-24). Out of the subsample analyzed in the current report, 130 patients (50.8%) were randomized to CBASP and 126 patients (49.2%) to SP. The mean age of the patients was 45.05 years (SD 11.8), 64.8% were female (n = 166). We imputed missing values for the HAQ, the IIP, and the HRSD-24 by using the mean of the posterior distribution from the fully conditional specification method obtained by the iterative Markov Chain Monte Carlo estimation.We examined sequential mediation via an ordinary leastsquares path analysis using a bootstrapping approach facilitated by the PROCESS macro version 2.16. The independent variable was group allocation (CBASP vs. SP), the dependent variable was the total score of the HRSD at week 48 (end of treatment), and the putative mediating variables were change of the HAQ between week 1 and the end of the acute treatment phase at week 20 (M 1 ) and subsequent change in the social inhibition subscale of the IIP during the continuation phase from week 20 to 48 (M 2 ). These time points were chosen to establish a temporal sequence of treatmentinduced changes in the therapeutic relationship followed by improvement in interpersonal functioning. For further details of the analysis, see Figure 1.This analysis revealed that a significant part of the association between treatment and outcome is mediated through the sequential indirect effect of improvement in HAQ (M 1 ) and reduction in the IIP social i...