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Cognitive Remediation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01903707
Recruitment Status : Unknown
Verified December 2014 by Gary Donohoe, University of Dublin, Trinity College.
Recruitment status was:  Recruiting
First Posted : July 19, 2013
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Gary Donohoe, 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Psychosis Other: Cognitive Remediation Therapy Other: Placebo comparator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: No intervention




Primary Outcome Measures :
  1. Change from baseline neuropsychological performance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903707


Contacts
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Contact: April H Hargreaves, PhD 353-1-8962465 hargrea@tcd.ie
Contact: Rachael Dillon, Bsc 353-1-8962315 radillon@tcd.ie

Locations
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Ireland
Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St. Recruiting
Dublin, Ireland, 8
Contact: April H Hargreaves, PhD    35318962624    hargrea@tcd.ie   
Contact: Rachael Dillon, BSc    35318962315    radillon@tcd.ie   
Principal Investigator: Gary J Donohue, DClin Psych PhD         
Sponsors and Collaborators
University of Dublin, Trinity College
Health Research Board, Ireland
Investigators
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Principal Investigator: Gary J Donoghoe, DClin Psych PhD Trinity College Dublin, Ireland

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Responsible Party: Gary Donohoe, Associate Professor, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01903707     History of Changes
Other Study ID Numbers: CRT001
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Gary Donohoe, University of Dublin, Trinity College:
Schizophrenia
Psychosis
Cognitive deficits

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders