Expectation focused and frequency enhanced cognitive behavioural therapy for patients with major depression (EFFECT): a study protocol of a randomised active-control trial.

INTRODUCTION: The effectiveness of psychotherapy in depression is subject of an ongoing debate. The mechanisms of change are still underexplored. Research tries to find influencing factors fostering the effect of psychotherapy. In that context, the dose-response relationship should receive more attention. Increasing the frequency from one to two sessions per week seems to be a promising start. Moreover, the concept of expectations and its influence in depression can be another auspicious approach. Dysfunctional expectations and the lack of their modification are central in symptom maintenance. Expectation focused psychological interventions (EFPI) have been investigated, primarily in the field of depression. The aim of this study is to compare cognitive behavioural therapy (CBT) once a week with an intensified version of CBT (two times a week) in depression as well as to include a third proof-of-principle intervention group receiving a condensed expectation focused CBT. METHODS AND ANALYSIS: Participants are recruited through an outpatient clinic in Germany. A current major depressive episode, diagnosed via structured clinical interviews should present as the main diagnosis. The planned randomised-controlled trial will allow comparisons between the following treatment conditions: CBT (one session/week), condensed CBT (two sessions/week) and EFPI (two sessions/week). All treatment arms include a total dose of 24 sessions. Depression severity applies as the outcome variable (Beck Depression Inventory II, Montgomery Asberg Depression Rating Scale). A sample size of n=150 is intended. ETHICS AND DISSEMINATION: The local ethics committee of the Department of Psychology, Philipps-University Marburg approved the study (reference number 2020-68 v). The final research article including the study results is intended to be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00023203).

Two-Year Follow-Up after Treatment with the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for Early-Onset Chronic Depression.

BACKGROUND: Evidence on the long-term efficacy of psychotherapeutic approaches for chronic depression is scarce. OBJECTIVE: 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. METHODS: 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 (n = 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. RESULTS: 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, p = 0.057, d = 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. CONCLUSIONS: 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.

Comparing the Efficacy of CBASP with Two Versions of CBT for Depression in a Routine Care Center: A Randomized Clinical Trial.

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.

Effect of Disorder-Specific vs Nonspecific Psychotherapy for Chronic Depression: A Randomized Clinical Trial.

IMPORTANCE: Chronic depression is a highly prevalent and disabling disorder. There is a recognized need to assess the value of long-term disorder-specific psychotherapy. OBJECTIVE: To evaluate the efficacy of the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) compared with that of nonspecific supportive psychotherapy (SP). DESIGN, SETTING, AND PARTICIPANTS: A prospective, multicenter, evaluator-blinded, randomized clinical trial was conducted among adult outpatients with early-onset chronic depression who were not taking antidepressant medication. Patients were recruited between March 5, 2010, and October 16, 2012; the last patient finished treatment on October 14, 2013. Data analysis was conducted from March 5, 2014, to October 27, 2016. INTERVENTIONS: The treatment included 24 sessions of CBASP or SP for 20 weeks in the acute phase, followed by 8 continuation sessions during the next 28 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was symptom severity after 20 weeks (blinded observer ratings) as assessed by the 24-item Hamilton Rating Scale for Depression (HRSD-24). Secondary outcomes were rates of response (reduction in HRSD-24 score of ≥50% from baseline) and remission (HRSD-24 score ≤8), as well as self-assessed ratings of depression, global functioning, and quality of life. RESULTS: Among 622 patients assessed for eligibility, 268 were randomized: 137 to CBASP (96 women [70.1%] and 41 men [29.9%]; mean [SD] age, 44.7 [12.1] years) and 131 to SP (81 women [61.8%] and 50 men [38.2%]; mean [SD] age, 45.2 [11.6] years). The mean (SD) baseline HRSD-24 scores of 27.15 (5.49) in the CBASP group and 27.05 (5.74) in the SP group improved to 17.19 (10.01) and 20.39 (9.65), respectively, after 20 weeks, with a significant adjusted mean difference of -2.51 (95% CI, -4.16 to -0.86; P = .003) and a Cohen d of 0.31 in favor of CBASP. After 48 weeks, the HRSD-24 mean (SD) scores were 14.00 (9.72) for CBASP and 16.49 (9.96) for SP, with an adjusted difference of -3.13 (95% CI, -5.01 to -1.25; P = .001) and a Cohen d of 0.39. Patients undergoing CBASP were more likely to reach response (48 of 124 [38.7%] vs 27 of 111 [24.3%]; adjusted odds ratio, 2.02; 95% CI, 1.09 to 3.73; P = .03) or remission (27 of 124 [21.8%] vs 14 of 111 [12.6%]; adjusted odds ratio, 3.55; 95% CI, 1.61 to 7.85; P = .002) after 20 weeks. Patients undergoing CBASP showed significant advantages in most other secondary outcomes. CONCLUSIONS AND RELEVANCE: Highly structured specific psychotherapy was moderately more effective than nonspecific therapy in outpatients with early-onset chronic depression who were not taking antidepressant medication. Adding an extended phase to acute psychotherapy seems promising in this population. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00970437.