Cognitive Remediation in Schizophrenia

Study Overview
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Brief Summary
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The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses. Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.

Detailed Description
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The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with schizophrenia. Pre and Post neuropsychological assessment and Magnetic Resonance Imagery (MRI) will be used to determine the effects of CR training on Neuropsychological performance Brain Structure using voxel-based morphometry (VBM) Brain function using functional MRI (fMRI) Social and occupational functioning The cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. Motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.

Official Title
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Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.

Conditions
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Schizophrenia, Psychosis

Intervention / Treatment
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* Other: Cognitive Remediation Therapy
* Other: Placebo comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia History of Psychosis Subjective difficulties with memory or concentration Aged 18-60 Years Exclusion Criteria: History of head injury resulting in loss of consciousness Substance misuse in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Remediation Therapy<br>Participants will undertake approximately 30 minutes of computerized CRT training for 8 weeks, 5 days per week. They will meet a therapist once per week to discuss any difficulties, help motivation. | Other: Cognitive Remediation Therapy<br>* Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks<br>* Other names: CRT;|
| Placebo Comparator: Placebo Comparator<br>Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training. | Other: Placebo comparator<br>* Participant meets the therapist once per week but does not carry out the CRT intervention. (Participants are subsequently offered the chance to carry out the CRT intervention post study if they so wish).<br>* Other names: No intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline neuropsychological performance | A battery of neuropsychological tests will be used at baseline and the same tests used directly after the intervention to measure changes in attention and memory. Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory. | Directly following study treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline neuropsychological performance at 3 to 6 months post intervention | A battery of neuropsychological tests will be used at baseline and the same tests used at 3 months post intervention to measure changes in attention and memory. Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory. | 3 to 6 months post study treatment period | 
| Changes from baseline in brain activation during working memory testing | Changes from baseline in brain activation during working memory testing will be measured using fMRI | Directly post study treatment period | 
| Change from baseline in grey matter volume | Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry. | Directly following study treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Psychosis, Cognitive deficits