title: Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: the POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial.
abstract: BACKGROUND
  It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention.
  
  
  METHODS
  The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency.
  
  
  CONCLUSIONS
  This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion on psychotherapy in psychotic disorders, and to help implement psychotherapy in routine care. Furthermore, the study will allow drawing conclusions about the mediators of treatment effects of CBT of psychotic disorders.
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Tuebingen, Germany. stefan.klingberg@med.uni-tuebingen.de
authors.forename: Stefan
authors.initials: S
authors.lastname: Klingberg
authors.forename: Andreas
authors.initials: A
authors.lastname: Wittorf
authors.forename: Christoph
authors.initials: C
authors.lastname: Meisner
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Wölwer
authors.forename: Georg
authors.initials: G
authors.lastname: Wiedemann
authors.forename: Jutta
authors.initials: J
authors.lastname: Herrlich
authors.forename: Andreas
authors.initials: A
authors.lastname: Bechdolf
authors.forename: Bernhard W
authors.initials: BW
authors.lastname: Müller
authors.forename: Gudrun
authors.initials: G
authors.lastname: Sartory
authors.forename: Michael
authors.initials: M
authors.lastname: Wagner
authors.forename: Tilo
authors.initials: T
authors.lastname: Kircher
authors.forename: Hans-Helmut
authors.initials: HH
authors.lastname: König
authors.forename: Corinna
authors.initials: C
authors.lastname: Engel
authors.forename: Gerhard
authors.initials: G
authors.lastname: Buchkremer
mesh_terms: D002983:Clinical Competence; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D006801:Humans; D010349:Patient Compliance; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000628:therapy*; D012107:Research Design; D016037:Single-Blind Method