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Clinical Trials/NCT01546467
NCT01546467
Unknown
Not Applicable

Cognitive Remediation in Early Phase Psychosis

Oslo University Hospital1 site in 1 country50 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Oslo University Hospital
Enrollment
50
Locations
1
Primary Endpoint
MATRICS Consensus Cognitive Battery (MCCB)
Last Updated
14 years ago

Overview

Brief Summary

The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).

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

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Early phase schizophrenia, schizoaffective disorder, psychosis NOS
  • Less than 5 years since start of adequate treatment for psychotic disorder
  • Age between 18-40
  • Norwegian speaking (sufficiently to understand and complete assessments)

Exclusion Criteria

  • Traumatic brain injury
  • Neurological disorder as determined by medical history
  • IQ below 70

Outcomes

Primary Outcomes

MATRICS Consensus Cognitive Battery (MCCB)

Time Frame: Change in MCCB performance from baseline to 4 months and 9 months

Included in the MCCB are measures of the following cognitive domains: Speed of Processing, Attention, Working memory, Verbal learning, Visual Learning, Reasoning and problem solving and Social Cognition. In addition the following tests are included: HVLT-R and BVMT-R delayed recall to measure memory, TMTB (Halstead Reitan) and Color Word Inteference Test (D-KEFS) to measure executive functioning), Digit span (WAIS-III)to measure working memory, Grooved Pegboard (Halstead Reitan) to measure motor function.

UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)

Time Frame: Change in UPSA-B performance from baseline to 4 months and 9 months

Cognitive Assessment Interview (CAI)

Time Frame: Change in CAI scores from baseline to 4 months and 9 months

Social Functioning Scale (SFS)

Time Frame: Change in SFS scores from baseline to 4 months and 9 months

Secondary Outcomes

  • Calgary Depression Scale(Change in CDS scores from baseline to 4 months and 9 months)
  • Global Assessment of Function (GAF)- split version(Change in GAF scores from baseline to 4 months and 9 months)
  • event related fMRI(Change in BOLD fMRI signal from baseline to 4 months)
  • Rosenberg Self-Esteem Scale (RSES)(Change in RSES scores from baseline to 4 months and 9 months)

Study Sites (1)

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