Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

September 8, 2005 updated by: University Hospital Tuebingen
The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
relapse

Secondary Outcome Measures

Outcome Measure
quality of life
quantitative measures of symptoms
social functioning
cognitive functioning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Stefan Klingberg, PD Dr. phil. Dipl. Psych., University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 8, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01GI9932-P2223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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