NCT00161408UnknownNot Applicable
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
University Hospital Tuebingen5 sites in 1 country106 target enrollmentStarted: December 1, 2000Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 106
- Locations
- 5
- Primary Endpoint
- relapse
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
relapse
Secondary Outcomes
- social functioning
- quantitative measures of symptoms
- cognitive functioning
- quality of life
Investigators
Study Sites (5)
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