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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
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Delusional Disorder Behavioral: Cognitive Behavioral Therapy Phase 3

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up

Secondary Outcome Measures :
  1. Depression before and after treatment and at 1-year-follow-up
  2. Dysfunctional Attitudes before and after treatment and at 1-year-follow-up
  3. Cognitive biases (jumping to conclusions, attribution, theory of mind) before and after treatment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations

Information from the National Library of Medicine

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


Contacts
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

Locations
Germany
Philipps-Universität Recruiting
Marburg, Germany, 35032
Principal Investigator: Tania M Lincoln, PhD         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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:
ClinicalTrials.gov Identifier: NCT00300651     History of Changes
Other Study ID Numbers: PhilippsU
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: March 9, 2006
Last Verified: March 2006

Keywords provided by Philipps University Marburg Medical Center:
Cognitive Behavioral Therapy
Schizophrenia
Cognitive Biases
Efficacy

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders