Trial of Cognitive Behavioral Therapy for Schizophrenia

Schizophrenia Clinical Trial

Official title:

Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00300651
• Other study ID #: PhilippsU
• Status: Recruiting
• Phase: Phase 3
• First received: March 8, 2006
• Last updated: March 8, 2006
• Start date: March 2006
• Est. completion date: August 2009

Study information

• Verified date: March 2006
• Source: Philipps University Marburg Medical Center
• Contact: Tania M Lincoln, PhD
• Phone: +49 (0)6421 2823647
• Email: lincoln[@]staff.uni-marburg.de
• Is FDA regulated: No
• Health authority: Germany: Philipps-Universität Marburg
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delusional Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Cognitive Behavioral Therapy

Locations

Country	Name	City	State
Germany	Philipps-Universität	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up
Secondary	Depression before and after treatment and at 1-year-follow-up
Secondary	Dysfunctional Attitudes before and after treatment and at 1-year-follow-up
Secondary	Cognitive biases (jumping to conclusions, attribution, theory of mind) before and after treatment