Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Schizophrenic Disorders Clinical Trial

Official title:

Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00161408
• Other study ID #: 01GI9932-P2223
• Status: Active, not recruiting
• Phase: N/A
• First received: September 8, 2005
• Last updated: September 8, 2005
• Start date: December 2000
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenic Disorders

Intervention

Behavioral:
• cognitive behavioural therapy

• psychoeducation

Locations

Country	Name	City	State
Germany	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 Psychotheray, University of Muenchen	Muenchen
Germany	Department of Psychiatry and Psychotherapy, University of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse
Secondary	quantitative measures of symptoms
Secondary	social functioning
Secondary	cognitive functioning
Secondary	quality of life