Cognitive Determinants of Psychoeducation and Information in Psychoses (COGPIP)
Primary Purpose
Schizophrenia, Delusional Disorders (ICD-10)
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
COGPACK training, psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizoaffective, schizotypal
Eligibility Criteria
Inclusion Criteria:
- Inpatients
- Informed consent
- German as first language or very good knowledge of German
Exclusion Criteria:
- Mental retardation
- Any serious somatic illness
Sites / Locations
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technical University of MunichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
no training
COGPACK training
Arm Description
Outcomes
Primary Outcome Measures
illness knowledge, adherence to treatment, insight to the illness, satisfaction with treatment. 9-month follow-up: number of rehospitalizations, days in hospital
Secondary Outcome Measures
Psychopathological status
Psychosocial rehabilitation
Full Information
NCT ID
NCT00646256
First Posted
March 25, 2008
Last Updated
March 25, 2008
Sponsor
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00646256
Brief Title
Cognitive Determinants of Psychoeducation and Information in Psychoses
Acronym
COGPIP
Official Title
Psychoeducation in Patients With Schizophrenia: Neuropsychological Performance and Cognitive Training as Determinants of Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Delusional Disorders (ICD-10)
Keywords
schizoaffective, schizotypal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no training
Arm Type
No Intervention
Arm Title
COGPACK training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
COGPACK training, psychoeducation
Intervention Description
Bifocal psychoeducation group program (Munich Psychoses Information Program - PIP) with preceding computerbased cognitive training program (COGPACK)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Psychopathological status
Title
Psychosocial rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients
Informed consent
German as first language or very good knowledge of German
Exclusion Criteria:
Mental retardation
Any serious somatic illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.
Phone
+49 (0)89-4140 4278
Email
th.jahn@lrz.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.
Organizational Affiliation
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klnikum rechts der Isar, Technbical Univesity Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technical University of Munich
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
20048350
Citation
Pitschel-Walz G, Bauml J, Frobose T, Gsottschneider A, Jahn T. Do individuals with schizophrenia and a borderline intellectual disability benefit from psychoeducational groups? J Intellect Disabil. 2009 Dec;13(4):305-20. doi: 10.1177/1744629509353237.
Results Reference
derived
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Cognitive Determinants of Psychoeducation and Information in Psychoses
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