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 Blind Primary Purpose: Treatment
Official Title:	Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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:

Related Info This link exits the ClinicalTrials.gov site


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 June 27, 2017

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