Cognitive Remediation in Early Phase Psychosis

Not Applicable

• Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis NOS
• Interventions: Behavioral: Cognitive remediation

• Registration Number: NCT01546467
• Lead Sponsor: Oslo University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-01-12
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-01
• Last Update Submitted: 2012-03-01
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive remediation	Cognitive remediation	30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program)

Primary Outcome Measures

Name	Time	Method
MATRICS Consensus Cognitive Battery (MCCB)	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)	Change in UPSA-B performance from baseline to 4 months and 9 months
Cognitive Assessment Interview (CAI)	Change in CAI scores from baseline to 4 months and 9 months
Social Functioning Scale (SFS)	Change in SFS scores from baseline to 4 months and 9 months

Secondary Outcome Measures

Name	Time	Method
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	Event-related fMRI will be performed to measure neuronal activity during a spatial working memory tasks and an executive planning task. All fMRI data will be collected on Ullevål's 3 T General Electric Sigma HDx scanner.
Rosenberg Self-Esteem Scale (RSES)	Change in RSES scores from baseline to 4 months and 9 months

Trial Locations

Locations (1)

Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.; 🇳🇴 Oslo, Norway