Cognitive Remediation in Schizophrenia

Sponsor
University of Dublin, Trinity College (Other)
Overall Status
Unknown status
CT.gov ID
NCT01903707
Collaborator
Health Research Board, Ireland (Other)
80
1
2
29
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Remediation Therapy
  • Other: Placebo comparator
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Cognitive Remediation Therapy
Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
Other Names:
  • CRT
  • Placebo Comparator: Placebo Comparator

    Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.

    Other: Placebo 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).
    Other Names:
  • No intervention
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    3. 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.

    Other Outcome Measures

    1. Changes in social and occupational functioning [Directly following study treatment period]

      Social 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)

    2. Change from baseline in social and occupational functioning 3 to 6 months post intervention [3 to 6 months post study treatment period]

      Social 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St. Dublin Ireland 8

    Sponsors and Collaborators

    • University of Dublin, Trinity College
    • Health Research Board, Ireland

    Investigators

    • Principal Investigator: Gary J Donoghoe, DClin Psych PhD, Trinity College Dublin, Ireland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Donohoe, Associate Professor, University of Dublin, Trinity College
    ClinicalTrials.gov Identifier:
    NCT01903707
    Other Study ID Numbers:
    • CRT001
    First Posted:
    Jul 19, 2013
    Last Update Posted:
    Dec 5, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Gary Donohoe, Associate Professor, University of Dublin, Trinity College
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 5, 2014