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Trial of Cognitive Behavioral Therapy for Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Delusional Disorder

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Behavioral Therapy, Schizophrenia, Cognitive Biases, Efficacy

Eligibility Criteria

16 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philipps-UniversitätRecruiting

Outcomes

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

Full Information

First Posted
March 8, 2006
Last Updated
March 8, 2006
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00300651
Brief Title
Trial of Cognitive Behavioral Therapy for Schizophrenia
Official Title
Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Delusional Disorder
Keywords
Cognitive Behavioral Therapy, Schizophrenia, Cognitive Biases, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up
Secondary Outcome Measure Information:
Title
Depression before and after treatment and at 1-year-follow-up
Title
Dysfunctional Attitudes before and after treatment and at 1-year-follow-up
Title
Cognitive biases (jumping to conclusions, attribution, theory of mind) before and after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania M Lincoln, PhD
Phone
+49 (0)6421 2823647
Email
lincoln@staff.uni-marburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Winfried Rief, Prof.
Phone
+49 (0)6421 2823641
Email
rief@staff.uni-marburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania M Lincoln, PhD
Organizational Affiliation
Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tania M Lincoln, PhD
Organizational Affiliation
Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Philipps-Universität
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania M Lincoln, PhD

12. IPD Sharing Statement

Links:
URL
http://www.psychotherapie-ambulanz-marburg.de/FrameSets/fsForschung.html
Description
Related Info

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Trial of Cognitive Behavioral Therapy for Schizophrenia

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