Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital Tuebingen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00161408
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014