Trial of Cognitive Behavioral Therapy for Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00300651|
Recruitment Status : Unknown
Verified March 2006 by Philipps University Marburg Medical Center.
Recruitment status was: Recruiting
First Posted : March 9, 2006
Last Update Posted : March 9, 2006
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Delusional Disorder||Behavioral: Cognitive Behavioral Therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia|
|Study Start Date :||March 2006|
|Estimated Study Completion Date :||August 2009|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300651
|Contact: Tania M Lincoln, PhD||+49 (0)6421 firstname.lastname@example.org|
|Contact: Winfried Rief, Prof.||+49 (0)6421 email@example.com|
|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|