Cognitive Determinants of Psychoeducation and Information in Psychoses (COGPIP)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2008 by German Research Foundation.
Recruitment status was Recruiting

Sponsor:

Information provided by:

German Research Foundation

ClinicalTrials.gov Identifier:

NCT00646256

First received: March 25, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 25, 2008

Last Updated Date

March 25, 2008

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Psychopathological status
Psychosocial rehabilitation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cognitive Determinants of Psychoeducation and Information in Psychoses

Official Title ^ICMJE

Psychoeducation in Patients With Schizophrenia: Neuropsychological Performance and Cognitive Training as Determinants of Outcome

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Delusional Disorders (ICD-10)

Intervention ^ICMJE

Behavioral: COGPACK training, psychoeducation

Bifocal psychoeducation group program (Munich Psychoses Information Program - PIP) with preceding computerbased cognitive training program (COGPACK)

Study Arm (s)

No Intervention: no training
Experimental: COGPACK training
Intervention: Behavioral: COGPACK training, psychoeducation

Publications *

Pitschel-Walz G, Bäuml J, Froböse 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Completion Date

Not Provided

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Inpatients
Informed consent
German as first language or very good knowledge of German

Exclusion Criteria:

Mental retardation
Any serious somatic illness

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.

+49 (0)89-4140 4278

th.jahn@lrz.tum.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00646256

Other Study ID Numbers ^ICMJE

DFG Ja 680 / 4-2, 4-3

Has Data Monitoring Committee

Responsible Party

Prof. Dr. phil. Dipl.-Psych. Thomas Jahn, Technical University of Munich

Study Sponsor ^ICMJE

German Research Foundation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klnikum rechts der Isar, Technbical Univesity Munich

Information Provided By

German Research Foundation

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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