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Clinical Trials/NCT01029067
NCT01029067
Completed
Not Applicable

Metacognitive Training (MCT) Compared With Cognitive Remediation (CR) in Schizophrenia: a Randomized Controlled Study Over 4 Weeks

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country60 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delusions
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
60
Locations
1
Primary Endpoint
delusion severity as assessed with the Positive and Negative Syndrome Scale (PANSS); sum of item scores p1, p5, p6 and g9
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Over a period of 4 weeks, metacognitive training for schizophrenia patients (MCT), delivered both in a group and individually, is compared to cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed before intervention and four weeks later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tests. Delusion severity serves as the primary endpoint. It is assumed that MCT will improve delusion severity to a greater extent than CR in the course of 4 weeks taking medication into account.

Detailed Description

Metacognitive training for schizophrenia patients (MCT) is a manualized group intervention that can be obtained cost-free online. MCT seeks to sharpen the awareness of schizophrenia spectrum patients on cognitive biases (e.g. jumping to conclusions) contributing to delusion formation and maintenance and conveys cognitive strategies to counter these. The present trial combines group MCT with an individualized cognitive-behavioral oriented approach entitled MCT+. Patients with schizophrenia are randomly allocated to either metacognitive treatment (MCT) or cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed prior to intervention and four weeks later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tasks. Delusion scores derived from the PANSS and PSYRATS serve as main outcome parameters. We also explore if MCT improves jumping to conclusions with a probabilistic reasoning task. To make results as generalizable as possible to a typical inpatient population, broad inclusion criteria are chosen. Patients are only excluded if age is \< 18 and \> 65 years and diagnoses do not meet criteria of a schizophrenia spectrum disorder.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • schizophrenia spectrum disorder

Exclusion Criteria

  • intellectual disability (IQ \< 70)
  • unable to provide informed consent
  • hostility on PANSS \> 4
  • suspiciousness on PANSS \> 5

Outcomes

Primary Outcomes

delusion severity as assessed with the Positive and Negative Syndrome Scale (PANSS); sum of item scores p1, p5, p6 and g9

Time Frame: 4 weeks

Study Sites (1)

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