Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trialReport as inadecuate




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 - Download this document for free, or read online. Document in PDF available to download.

Trials

, 11:123

First Online: 29 December 2010Received: 27 September 2010Accepted: 29 December 2010DOI: 10.1186-1745-6215-11-123

Cite this article as: Klingberg, S., Wittorf, A., Meisner, C. et al. Trials 2010 11: 123. doi:10.1186-1745-6215-11-123

Abstract

BackgroundIt 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-DesignThe 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.

DiscussionThis 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 RegistrationCurrent Controlled Trials ISRCTN29242879

List of abbreviations usedBMBFBundesministerium für Bildung und Forschung German Federal Ministry of Education and Research

CBTCognitive Behavioral Therapy

CDSSCalgary Depression Rating Scale for Schizophrenia

CGIClinical Global Impression

CONSORTConsolidated Standards of Reporting Trials

CTS-PsyCognitive Therapy Scale for Psychosis

DGPPNDeutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde German Psychiatric Association

DSM-IVDiagnostic and Statistical Manual of Mental Disorders, Forth Edition

DSMCData and safety monitoring committee

eCRFelectronic Case Report Form

TAUTreatment As Usual

FSKNFrankfurt Self-Concept Scales

IMBInstitute for Medical Biometry

IQIntelligence Quotient

mCBTmodified Cognitive Behavioral Therapy

MWT-BMehrfachwahl Wortschatz Intelligenztest multiple choice vocabulary intelligence test

PANSSPositive and Negative Syndrome Scale

SCID-IStructured Clinical Interview for the DSM-IV, Axis I

STSupportive Therapy

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-11-123 contains supplementary material, which is available to authorized users.

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Author: Stefan Klingberg - Andreas Wittorf - Christoph Meisner - Wolfgang Wölwer - Georg Wiedemann - Jutta Herrlich - Andreas Bech

Source: https://link.springer.com/







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