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Open Access Study protocol

Psychoanalytic and cognitive-behavior therapy of chronic depression: study protocol for a randomized controlled trial

Manfred E Beutel1*, Marianne Leuzinger-Bohleber2, Bernhard Rüger3, Ulrich Bahrke2, Alexa Negele2, Antje Haselbacher1, Georg Fiedler4, Wolfram Keller5 and Martin Hautzinger6

Author Affiliations

1 Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany

2 Sigmund-Freund-Institute, Goethe-University Frankfurt, University of Kassel, Frankfurt, Germany

3 Center for Documentation, Statistics, and Data analyses, Ludwig-Maximilians University Munich, Munich, Germany

4 Department of Psychosomatic Medicine and Psychotherapy, University Clinic Hamburg-Eppendorf, Hamburg, Germany

5 Clinics in the Theodor-Wenzel-Werk, Department of Psychosomatic Medicine and Psychotherapy, Berlin, Germany

6 Section Clinical Psychology & Psychotherapy, University Hospital Tübingen, Tübingen, Germany

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Trials 2012, 13:117  doi:10.1186/1745-6215-13-117

Published: 26 July 2012

Abstract

Background

Despite limited effectiveness of short-term psychotherapy for chronic depression, there is a lack of trials of long-term psychotherapy. Our study is the first to determine the effectiveness of controlled long-term psychodynamic and cognitive-behavioral (CBT) treatments and to assess the effects of preferential vs. randomized assessment.

Methods/design

Patients are assigned to treatment according to their preference or randomized (if they have no clear preference). Up to 80 sessions of psychodynamic or psychoanalytically oriented treatments (PAT) or up to 60 sessions of CBT are offered during the first year in the study. After the first year, PAT can be continued according to the ‘naturalistic’ usual method of treating such patients within the system of German health care (normally from 240 up to 300 sessions over two to three years). CBT therapists may extend their treatment up to 80 sessions, but focus mainly maintenance and relapse prevention. We plan to recruit a total of 240 patients (60 per arm). A total of 11 assessments are conducted throughout treatment and up to three years after initiation of treatment. The primary outcome measures are the Quick Inventory of Depressive Symptoms (QIDS, independent clinician rating) and the Beck Depression Inventory (BDI) after the first year.

Discussion

We combine a naturalistic approach with randomized controlled trials(RCTs)to investigate how effectively chronic depression can be treated on an outpatient basis by the two forms of treatment reimbursed in the German healthcare system and we will determine the effects of treatment preference vs. randomization.

Trial registration

http://www.controlled-trials.com/ISRCTN91956346 webcite

Keywords:
Chronic depression; Cognitive behavioral therapy; Psychodynamic psychotherapy