Study protocol
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
1 Department of Psychiatry and Psychotherapy, University of Tuebingen, Germany
2 Institute for Medical Biometry, University of Tuebingen, Germany
3 Department of Psychiatry and Psychotherapy, University of Düsseldorf, Germany
4 Department of Psychiatry and Psychotherapy, University of Frankfurt/Main, Germany
5 Clinical Center Fulda, Clinic for Psychiatry and Psychotherapy, Fulda, Germany
6 Department of Psychiatry and Psychotherapy, University of Cologne, Germany
7 Department of Psychiatry and Psychotherapy, University of Duisburg-Essen, Germany
8 Department of Clinical Psychology, University of Wuppertal, Germany
9 Department of Psychiatry and Psychotherapy, University of Bonn, Germany
10 Department of Psychiatry and Psychotherapy, University of Marburg, Germany
11 Department of Medical Sociology and Health Economics, Center for Psycho-social Medicine, University Medical Center Hamburg-Eppendorf, Germany
Trials 2010, 11:123 doi:10.1186/1745-6215-11-123
Published: 29 December 2010Abstract
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/Design
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.
Discussion
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.
Trial Registration
Current Controlled Trials ISRCTN29242879
