Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
Primary Purpose
Schizophrenic Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
cognitive behavioural therapy
psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenic Disorders focused on measuring schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
Eligibility Criteria
Inclusion Criteria: diagnosis of schizophrenic disorder according to ICD 10: F20 first episode age between 18 and 55 willingness to give informed consent also to a double blind pharmacological treatment study Exclusion Criteria: residence outside of the catchment area insufficient knowledge of the German language substance abuse or addiction as primary clinical problem serious physical illness organic brain disease pregnancy contraindications to neuroleptic treatment
Sites / Locations
- Department of Psychiatry and Psychotherapy, University of Bonn
- Department of Psychiatry and Psychotherapy, University of Cologne
- Department of Psychiatry and Psychotherapy, University of Duesseldorf
- Department of Psychiatry and Psychotheray, University of Muenchen
- Department of Psychiatry and Psychotherapy, University of Tuebingen
Outcomes
Primary Outcome Measures
relapse
Secondary Outcome Measures
quantitative measures of symptoms
social functioning
cognitive functioning
quality of life
Full Information
NCT ID
NCT00161408
First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00161408
Brief Title
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
Official Title
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
5. Study Description
Brief Summary
The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia
Detailed Description
Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (ICP) of 8 sessions or a "cognitive behavioral treatment" (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms.
The primary endpoint is relapse at the one and two year follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenic Disorders
Keywords
schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioural therapy
Intervention Type
Behavioral
Intervention Name(s)
psychoeducation
Primary Outcome Measure Information:
Title
relapse
Secondary Outcome Measure Information:
Title
quantitative measures of symptoms
Title
social functioning
Title
cognitive functioning
Title
quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of schizophrenic disorder according to ICD 10: F20
first episode
age between 18 and 55
willingness to give informed consent also to a double blind pharmacological treatment study
Exclusion Criteria:
residence outside of the catchment area
insufficient knowledge of the German language
substance abuse or addiction as primary clinical problem
serious physical illness
organic brain disease
pregnancy
contraindications to neuroleptic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Klingberg, PD Dr. phil. Dipl. Psych.
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University of Cologne
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University of Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40629
Country
Germany
Facility Name
Department of Psychiatry and Psychotheray, University of Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
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Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
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