Cognitive Remediation in Early Phase Psychosis

Study Overview
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Brief Summary
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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).

Official Title
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Cognitive Remediation in Early Phase Psychosis

Conditions
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Schizophrenia, Schizoaffective Disorder, Psychosis NOS

Intervention / Treatment
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* Behavioral: Cognitive remediation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive remediation<br>30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program) | Behavioral: Cognitive remediation<br>* Cognitive remediation including feedback from neurocognitive assessment, psychoeducation about cognitive deficits, 30 hours of computer based drill and practise and strategy coaching based cognitive remediation, 1-3 collaborative meetings with cognitive specialist, participant, therapist and teacher, occupational therapist or other therapist (depending on participants rehabilitation situation) to enhance transfer of skills to daily functioning<br>|
| No Intervention: Wait list control group<br>Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MATRICS Consensus Cognitive Battery (MCCB) | 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. | Change in MCCB performance from baseline to 4 months and 9 months | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizoaffective disorder, Functional outcome, Schizophrenia, Psychosis, Early phase, Cognitive remediation