Cognitive Determinants of Psychoeducation and Information in Psychoses

Schizophrenia Clinical Trial

— COGPIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00646256
• Other study ID #: DFG Ja 680 / 4-2, 4-3
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2008
• Last updated: March 25, 2008
• Start date: February 2006

Study information

• Verified date: March 2008
• Source: German Research Foundation
• Contact: Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.
• Phone: +49 (0)89-4140 4278
• Email: th.jahn[@]lrz.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Inpatients

• Informed consent

• German as first language or very good knowledge of German

Exclusion Criteria:

• Mental retardation

• Any serious somatic illness

Study Design

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

Related Conditions & MeSH terms

• Delusional Disorders (ICD-10)
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technical University of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	illness knowledge, adherence to treatment, insight to the illness, satisfaction with treatment. 9-month follow-up: number of rehospitalizations, days in hospital		Baseline, after cognitive training, after psychoeducation, 9-month after end of psychoeducation
Secondary	Psychopathological status
Secondary	Psychosocial rehabilitation