Trial of Cognitive Behavioral Therapy for Schizophrenia
Recruitment status was: Recruiting
Behavioral: Cognitive Behavioral Therapy
|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
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300651
|Marburg, Germany, 35032|
|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|