Cognitive Remediation in Schizophrenia

Not Applicable

• Conditions: Schizophrenia; Psychosis
• Interventions: Other: Placebo comparator; Other: Cognitive Remediation Therapy

• Registration Number: NCT01903707
• Lead Sponsor: University of Dublin, Trinity College

Brief Summary

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

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

1. Neuropsychological performance

2. Brain Structure using voxel-based morphometry (VBM)

3. Brain function using functional MRI (fMRI)

4. 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-19
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05
• Primary Completion: 2015-06
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Schizophrenia
• History of Psychosis
• Subjective difficulties with memory or concentration
• Aged 18-60 Years

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Exclusion Criteria

• History of head injury resulting in loss of consciousness
• Substance misuse in the last 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo comparator	Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
Cognitive Remediation Therapy	Cognitive Remediation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline neuropsychological performance	Directly following study treatment period	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline neuropsychological performance at 3 to 6 months post intervention	3 to 6 months post study treatment period	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.
Changes from baseline in brain activation during working memory testing	Directly post study treatment period	Changes from baseline in brain activation during working memory testing will be measured using fMRI
Change from baseline in grey matter volume	Directly following study treatment period	Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.

Trial Locations

Locations (1)

Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.; 🇮🇪 Dublin, Ireland