Trial of Cognitive Behavioral Therapy for Schizophrenia

NCT ID: NCT00300651

Last Updated: 2006-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Delusional Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Principal Investigators

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Tania M Lincoln, PhD

Role: PRINCIPAL_INVESTIGATOR

Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy

Tania M Lincoln, PhD

Role: STUDY_DIRECTOR

Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy

Locations

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Philipps-Universität

Marburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Tania M Lincoln, PhD

Role: CONTACT

+49 (0)6421 2823647

Winfried Rief, Prof.

Role: CONTACT

+49 (0)6421 2823641

Related Links

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Other Identifiers

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PhilippsU

Identifier Type: -

Identifier Source: org_study_id