- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00646256
Cognitive Determinants of Psychoeducation and Information in Psychoses (COGPIP)
March 25, 2008 updated by: German Research Foundation
Psychoeducation in Patients With Schizophrenia: Neuropsychological Performance and Cognitive Training as Determinants of Outcome
The aim of the study is to examine whether the efficacy of psychoeducation in patients with schizophrenia or schizoaffective disorders is dependent on their cognitive performance level and if a preceding cognitive training can enhance the therapeutic effects of psychoeducation
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Schizophrenic inpatients are examined shortly after admission with a broad battery of clinical and neurological rating scales and neuropsychological tests.
They are then randomized to either standard treatment (including antipsychotic medications, art and occupational therapy, psychotherapy) or to standard treatment plus daily computerbased cognitive training (COGPACK; ten 1-hour sessions over two weeks).
After repetition of the broad assessment battery all patients (and some of their family members) take part in a bifocal psychoeducation group program (eight 1-hour sessions over four weeks).
Specific pre-post measures are illness knowledge, self and expert ratings of adherence to treatment, insight to the illness, treatment satisfaction.
The study also includes a 9-month follow-up, with number of rehospitalizations, days in hospital and psychopathology as the primary outcome measures.
Study Type
Interventional
Enrollment (Anticipated)
120
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 Contact
- Name: Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.
- Phone Number: +49 (0)89-4140 4278
- Email: th.jahn@lrz.tum.de
Study Locations
-
-
-
Munich, Germany, 81675
- Recruiting
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technical University of Munich
-
-
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
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inpatients
- Informed consent
- German as first language or very good knowledge of German
Exclusion Criteria:
- Mental retardation
- Any serious somatic illness
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: no training
|
|
Experimental: COGPACK training
|
Bifocal psychoeducation group program (Munich Psychoses Information Program - PIP) with preceding computerbased cognitive training program (COGPACK)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
illness knowledge, adherence to treatment, insight to the illness, satisfaction with treatment. 9-month follow-up: number of rehospitalizations, days in hospital
Time Frame: Baseline, after cognitive training, after psychoeducation, 9-month after end of psychoeducation
|
Baseline, after cognitive training, after psychoeducation, 9-month after end of psychoeducation
|
Secondary Outcome Measures
Outcome Measure |
---|
Psychopathological status
|
Psychosocial rehabilitation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Jahn, Prof. Dr. phil. Dipl.-Psych., Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klnikum rechts der Isar, Technbical Univesity Munich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2006
Primary Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
March 25, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (Estimate)
March 28, 2008
Study Record Updates
Last Update Posted (Estimate)
March 28, 2008
Last Update Submitted That Met QC Criteria
March 25, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFG Ja 680 / 4-2, 4-3
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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