Trial of Cognitive Behavioral Therapy for Schizophrenia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
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
Study Completion Date :	August 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

ClinicalTrials.gov Identifier:	NCT00300651 History of Changes
Other Study ID Numbers:	PhilippsU
First Posted:	March 9, 2006
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