Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

BMC Psychiatry

Study Protocol

Levente Kriston¹  Martin Härter¹  Elisabeth Schramm²  Mathias Berger²  Ingo Zobel²  Martin Hautzinger³ 

[1] Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany;Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Hauptstraße 5, 79104, Freiburg, Germany;Department of Psychology, University of Tuebingen, Christophstr. 2, 72072, Tuebingen, Germany;

关键词: Major Depressive Episode;    Brief Symptom Inventory;    Chronic Depression;    Childhood Trauma Questionnaire;    Dysthymic Disorder;   

DOI  :  10.1186/1471-244X-11-134

 received in 2011-06-10, accepted in 2011-08-17,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundEffective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment.Methods/DesignThe present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied.DiscussionThe study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients.Trial registrationClinicalTrials.gov (NCT00970437).

【 授权许可】

CC BY   
© Schramm et al; licensee BioMed Central Ltd. 2011