Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Not Applicable

• Conditions: Schizophrenic Disorders

• Registration Number: NCT00161408
• Lead Sponsor: University Hospital Tuebingen

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 Timeline

• Study Start: 2000-12
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Last Update Submitted: 2005-09-08
• Study First Posted: 2005-09-12
• Last Update Posted: 2005-09-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
relapse

Secondary Outcome Measures

Name	Time	Method
social functioning
quantitative measures of symptoms
cognitive functioning
quality of life

Trial Locations

Locations (5)

Department of Psychiatry and Psychotherapy, University of Bonn; 🇩🇪 Bonn, Germany

Department of Psychiatry and Psychotherapy, University of Cologne; 🇩🇪 Cologne, Germany

Department of Psychiatry and Psychotherapy, University of Duesseldorf; 🇩🇪 Duesseldorf, Germany

Department of Psychiatry and Psychotherapy, University of Tuebingen; 🇩🇪 Tuebingen, Germany

Department of Psychiatry and Psychotheray, University of Muenchen; 🇩🇪 Muenchen, Germany