Cognitive Remediation in Schizophrenia
Primary Purpose
Schizophrenia, Psychosis
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Cognitive deficits
Eligibility 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
Sites / Locations
- Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cognitive Remediation Therapy
Placebo Comparator
Arm Description
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.
Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT01903707
First Posted
July 2, 2013
Last Updated
December 4, 2014
Sponsor
University of Dublin, Trinity College
Collaborators
Health Research Board, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT01903707
Brief Title
Cognitive Remediation in Schizophrenia
Official Title
Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College
Collaborators
Health Research Board, Ireland
4. Oversight
Data Monitoring Committee
No
5. 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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychosis
Keywords
Schizophrenia, Psychosis, Cognitive deficits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation Therapy
Other Intervention Name(s)
CRT
Intervention Description
Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Other Intervention Name(s)
No intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline neuropsychological performance
Description
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.
Time Frame
Directly following study treatment period
Secondary Outcome Measure Information:
Title
Change from baseline neuropsychological performance at 3 to 6 months post intervention
Description
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.
Time Frame
3 to 6 months post study treatment period
Title
Changes from baseline in brain activation during working memory testing
Description
Changes from baseline in brain activation during working memory testing will be measured using fMRI
Time Frame
Directly post study treatment period
Title
Change from baseline in grey matter volume
Description
Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.
Time Frame
Directly following study treatment period
Other Pre-specified Outcome Measures:
Title
Changes in social and occupational functioning
Description
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)
Time Frame
Directly following study treatment period
Title
Change from baseline in social and occupational functioning 3 to 6 months post intervention
Description
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)
Time Frame
3 to 6 months post study treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April H Hargreaves, PhD
Phone
353-1-8962465
Email
hargrea@tcd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Rachael Dillon, Bsc
Phone
353-1-8962315
Email
radillon@tcd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary J Donoghoe, DClin Psych PhD
Organizational Affiliation
Trinity College Dublin, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April H Hargreaves, PhD
Phone
35318962624
Email
hargrea@tcd.ie
First Name & Middle Initial & Last Name & Degree
Rachael Dillon, BSc
Phone
35318962315
Email
radillon@tcd.ie
First Name & Middle Initial & Last Name & Degree
Gary J Donohue, DClin Psych PhD
12. IPD Sharing Statement
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Cognitive Remediation in Schizophrenia
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