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Trial of Cognitive Behavioral Therapy for Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by Philipps University Marburg Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00300651
First received: March 8, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

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

Secondary Outcome Measures:
  • 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
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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 8, 2006
Last Updated: March 8, 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

ClinicalTrials.gov processed this record on September 21, 2017