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Clinical Trial Summary

The major objective of this randomized controlled study is to compare a new conceptualized personalized concept of Cognitive Behavioral Analysis System of Psychotherapy (CBASPersonalized) with a six-week waiting-list control (WLC) group and a version of Cognitive Behavioral Therapy (CBIntegrative) in the treatment of patients with persistent depressive disorder (PDD), childhood maltreatment, and treatment-resistance. Both active groups will be offered as treatment-phase programs (six-week inpatient-treatment and optional six-week blended-online-aftercare) in combination with standardized pharmacotherapy in a routine clinical inpatient setting. This study addresses the primary research question: Is the intensive six-week inpatient CBASPersonalized treatment more effective than a six-week WLC in a clinical sample of PDD patients? In addition, CBASPersonalized will be compared with CBIntegrative investigating differential indication by moderator, mediator, and process analyses.


Clinical Trial Description

Background: Persistent depressive disorder (PDD) is a prevalent disabling disorder. Given its high degree of treatment-resistance (TR), comorbidity, and suicidality, this patient group constitutes a massive health problem. The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) was specifically developed for the outpatient treatment of PDD showing superiority to active control groups in some studies, yet not to the 'gold-standard' Cognitive Behavioral Therapy (CBT). In addition, non-remission and relapse rates of CBASP are relatively high, which might be caused by the fact that within the original CBASP-concept the frequent comorbid disorders are not sufficiently addressed. Thus, an optimized personalized CBASP-concept (CBASPersonalized) was established including the interpersonal CBASP-strategies while adding evidence-based intrapersonal strategies being tailored to the specific comorbid problems. In this study, the investigators will compare CBASPersonalized with I) a six-week waiting-list control (WLC) and II) CBT integrating strategies from the Acceptance and Commitment Therapy (CBIntegrative). Both active groups will be offered as treatment-phase programs (six-week inpatient-treatment and optional six-week blended-online-aftercare) in combination with standardized pharmacotherapy in a routine clinical inpatient setting.

Methods: In the proposed prospective, mono-site, evaluator-blinded, randomized-controlled study, 192 PDD patients with childhood maltreatment and TR will be included. The study addresses the primary research question: Is the six-week inpatient CBASPersonalized-treatment more effective than a six-week WLC in PDD? It is hypothesized that six weeks after randomization, CBASPersonalized will significantly outperform WLC concerning reduction in depressive symptomatology (according to the 24-item version of the Hamilton Rating Scale of Depression, HRSD). In addition, the investigators will compare CBASPersonalized with CBIntegrative investigating differential indication by moderator, mediator, and process analyses. Primary and secondary outcome will be analyzed using analysis of covariance (ANCOVA) controlling for pre-treatment scores. Moderator, mediator, and process analyses will be performed using multiple regression and linear mixed models. A follow-up survey 6 months after end of treatment will provide important results on long-term treatment outcome.

Discussion: The results of this study may have the potential to alleviate the burden of this serious and cost-intensive disease while improving public health. In addition, moderator and mediator analyses may guide personalized treatment and enable therapists to address psychotherapeutic needs of PDD patients more specifically. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03616665
Study type Interventional
Source Philipps University Marburg Medical Center
Contact Eva-Lotta Brakemeier, Prof. Dr.
Phone +491711278600
Email eva-lotta.brakemeier@uni-marburg.de
Status Not yet recruiting
Phase N/A
Start date November 20, 2018
Completion date May 20, 2021

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