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Cognitive Remediation in Schizophrenia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01903707
Enrollment
80
Registered
2013-07-19
Start date
2013-05-31
Completion date
2015-10-31
Last updated
2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis, Schizophrenia

Keywords

Schizophrenia, Psychosis, Cognitive deficits

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.

Interventions

OTHERCognitive Remediation Therapy

Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks

OTHERPlacebo comparator

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).

Sponsors

Health Research Board, Ireland
CollaboratorOTHER
University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline neuropsychological performanceDirectly following study treatment periodA 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

MeasureTime frameDescription
Change from baseline neuropsychological performance at 3 to 6 months post intervention3 to 6 months post study treatment periodA 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 testingDirectly post study treatment periodChanges from baseline in brain activation during working memory testing will be measured using fMRI
Change from baseline in grey matter volumeDirectly following study treatment periodChanges in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.

Other

MeasureTime frameDescription
Changes in social and occupational functioningDirectly following study treatment periodSocial and occupational function will be measured at baseline and the same tests used directly following intervention. Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
Change from baseline in social and occupational functioning 3 to 6 months post intervention3 to 6 months post study treatment periodSocial and occupational function will be measured at baseline and the same tests used directly following intervention. Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)

Countries

Ireland

Contacts

Primary ContactApril H Hargreaves, PhD
hargrea@tcd.ie353-1-8962465
Backup ContactRachael Dillon, Bsc
radillon@tcd.ie353-1-8962315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026