Trial of Cognitive Behavioral Therapy for Schizophrenia
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia |
- Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up
- Depression before and after treatment and at 1-year-follow-up
- Dysfunctional Attitudes before and after treatment and at 1-year-follow-up
- Cognitive biases (jumping to conclusions, attribution, theory of mind) before and after treatment
| 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:
- persons with a primary diagnosis of schizophrenia, schizoaffective disorder, delusional disorder acute or in incomplete remission a value of at least 3 on delusions, P1, P3 or G9 in Positive and Negative Syndrome Scale
fluent in German language
Exclusion Criteria:
- severe organic brain disease
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00300651
| 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00300651 History of Changes |
| Other Study ID Numbers: | PhilippsU |
| Study First Received: | March 8, 2006 |
| Last Updated: | March 8, 2006 |
| Health Authority: | Germany: Philipps-Universität Marburg |
Keywords provided by Philipps University Marburg Medical Center:
|
Cognitive Behavioral Therapy Schizophrenia Cognitive Biases Efficacy |
Additional relevant MeSH terms:
|
Disease Psychotic Disorders Schizophrenia |
Mental Disorders Pathologic Processes Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on February 25, 2015