title: 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.
abstract: BACKGROUND
  Effective 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
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT00970437).
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Hauptstraße 5, 79104 Freiburg, Germany. Elisabeth.Schramm@uniklinik-freiburg.de
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Schramm
authors.forename: Martin
authors.initials: M
authors.lastname: Hautzinger
authors.forename: Ingo
authors.initials: I
authors.lastname: Zobel
authors.forename: Levente
authors.initials: L
authors.lastname: Kriston
authors.forename: Mathias
authors.initials: M
authors.lastname: Berger
authors.forename: Martin
authors.initials: M
authors.lastname: Härter
mesh_terms: D000293:Adolescent; D000328:Adult; D017668:Age of Onset; D000368:Aged; D002908:Chronic Disease; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care / Q000379:methods*; D011613:Psychotherapy / Q000379:methods*; D012944:Social Support