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| Sponsored by: |
Philipps University Marburg Medical Center |
|---|---|
| Information provided by: | Philipps University Marburg Medical Center |
| ClinicalTrials.gov Identifier: | NCT00300651 |
Purpose
The following study addresses the hypothesis that cognitive-behavioral interventions will be effective in reducing positive and negative symptoms of schizophrenia under the conditions of the German health care system. It is also hypothesized that interventions designed to reduce delusions will reduce cognitive biases and dysfunctional self-concepts.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Delusional Disorder |
Behavioral: Cognitive Behavioral Therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia |
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | August 2009 |
Background: In spite of the proven effectiveness in a series of randomized controlled studies, cognitive-behavioural interventions for the treatment of symptoms of schizophrenia have been not yet been evaluated under the conditions of the German health care system. Additionally, it remains unclear which processes are responsible for reducing positive symptoms using CBT-interventions.
Hypothesis: The following study addresses the hypothesis that CBT will be effective in reducing positive and negative symptoms of schizophrenia. It is also hypothesized that CBT will reduce cognitive biases and dysfunctional self-concepts.
Method: 70 patients with a primary diagnosis of schizophrenia will be randomized to a CBT-treatment- and a waiting-list-control-group. CBT involves a formulation-based treatment of approximately 25 sessions by trained and supervised therapists plus standard care (psychiatric medical treatment) in an outpatient setting. Participants will be referred from cooperating psychiatrists. Patients randomized to the waiting-list condition take part in the assessment phase, then receive standard care alone for 12 weeks and are then offered CBT. The primary outcome measure will be the Positive and Negative Syndrome Scale. Additionally, depression, dysfunctional self-concepts and cognitive biases will be assessed before and after treatment.
Eligibility| Ages Eligible for Study: | 16 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
fluent in German language
Exclusion Criteria:
Contacts and Locations| Contact: Tania M Lincoln, PhD | +49 (0)6421 2823647 | lincoln@staff.uni-marburg.de |
| Contact: Winfried Rief, Prof. | +49 (0)6421 2823641 | rief@staff.uni-marburg.de |
| Germany | |
| Philipps-Universität | Recruiting |
| Marburg, Germany, 35032 | |
| Principal Investigator: Tania M Lincoln, PhD | |
| Principal Investigator: | Tania M Lincoln, PhD | Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy |
| Study Director: | Tania M Lincoln, PhD | Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy |
More Information
| Study ID Numbers: | PhilippsU |
| Study First Received: | March 8, 2006 |
| Last Updated: | March 8, 2006 |
| ClinicalTrials.gov Identifier: | NCT00300651 History of Changes |
| Health Authority: | Germany: Philipps-Universität Marburg |
|
Cognitive Behavioral Therapy Schizophrenia Cognitive Biases Efficacy |
|
Schizophrenia Schizophrenia, Paranoid Delusions |
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
|
Schizophrenia Schizophrenia, Paranoid Pathologic Processes Disease |
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
