Psychological Intervention for Relapse Prevention in First Episode Schizophrenia - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00161408

Purpose

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

Condition	Intervention
Schizophrenic Disorders	Behavioral: cognitive behavioural therapy Behavioral: psychoeducation

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

relapse

Secondary Outcome Measures:

quantitative measures of symptoms
social functioning
cognitive functioning
quality of life

Estimated Enrollment:	106
Study Start Date:	December 2000
Estimated Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161408

Locations

Germany
Department of Psychiatry and Psychotherapy, University of Tuebingen
Tuebingen, Germany, 72076
Department of Psychiatry and Psychotherapy, University of Bonn
Bonn, Germany, 53105
Department of Psychiatry and Psychotherapy, University of Duesseldorf
Duesseldorf, Germany, 40629
Department of Psychiatry and Psychotherapy, University of Cologne
Cologne, Germany, 50924
Department of Psychiatry and Psychotheray, University of Muenchen
Muenchen, Germany, 80336

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Stefan Klingberg, PD Dr. phil. Dipl. Psych.

University Hospital Tuebingen

More Information

Study ID Numbers:	01GI9932-P2223
Study First Received:	September 8, 2005
Last Updated:	September 8, 2005
ClinicalTrials.gov Identifier:	NCT00161408
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:

schizophrenia, first episode, cognitive behavioural therapy, psychoeducation

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009