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Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00161408
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161408


Locations
Germany
Department of Psychiatry and Psychotherapy, University of Bonn
Bonn, Germany, 53105
Department of Psychiatry and Psychotherapy, University of Cologne
Cologne, Germany, 50924
Department of Psychiatry and Psychotherapy, University of Duesseldorf
Duesseldorf, Germany, 40629
Department of Psychiatry and Psychotheray, University of Muenchen
Muenchen, Germany, 80336
Department of Psychiatry and Psychotherapy, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Stefan Klingberg, PD Dr. phil. Dipl. Psych. University Hospital Tuebingen
  More Information

ClinicalTrials.gov Identifier: NCT00161408     History of Changes
Other Study ID Numbers: 01GI9932-P2223
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by University Hospital Tuebingen:
schizophrenia, first episode, cognitive behavioural therapy, psychoeducation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders