This trial is active, not recruiting.

Condition schizophrenic disorders
Treatments cognitive behavioural therapy, psychoeducation
Sponsor University Hospital Tuebingen
Start date December 2000
End date September 2005
Trial size 106 participants
Trial identifier NCT00161408, 01GI9932-P2223


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

time frame:

Secondary Outcomes

quantitative measures of symptoms
time frame:
social functioning
time frame:
cognitive functioning
time frame:
quality of life
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
Principal investigator Stefan Klingberg, PD Dr. phil. Dipl. Psych.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.