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Effectiveness of Cognitive Remediation in a Supported Education Setting

This study is currently recruiting participants.
Verified December 2012 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
George Brown College
Information provided by (Responsible Party):
Sean Kidd, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01492439
First received: December 13, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether cognitive remediation as an adjunct to supported education, will result in improved cognitive functioning, symptoms, and performance in academic domains for persons with psychosis compared to supported education given alone.


Condition Intervention
Psychosis
 Behavioral: Cognitive Remediation
Behavioral: Supported Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Academic performance as measured by number of courses missed, course grades and the number of classes successfully completed. [ Time Frame: The end of the semester (i.e. 3 months following Baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the Positive and Negative Symptoms Scale (PANSS) score [ Time Frame: 3 months following baseline ] [ Designated as safety issue: No ]
    Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale, which is the most commonly used measure in cognitive remediation studies.

  • Change in The Rosenberg Self-Esteem Scale Score [ Time Frame: 3 months following Baseline ] [ Designated as safety issue: No ]
  • Change in the Positive and Negative Symptoms Scale (PANSS) score [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
  • Change in The Rosenberg Self-Esteem Scale Score [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
  • Change in performance on the California Verbal Learning Test [ Time Frame: 3 months following Baseline Assessment ] [ Designated as safety issue: No ]
    Verbal learning and memory will be assessed with the California Verbal Learning Test. The CVLT involves the repeated presentation of a word list that determines acquisition ability and retention.

  • Change in performance on the California Verbal Learning Test [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    Verbal learning and memory will be assessed with the California Verbal Learning Test. The CVLT involves the repeated presentation of a word list that determines acquisition ability and retention.

  • Change in performance on the The Trail Making test part A [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making test part A, a test involving using lines to connect numbers, will be used to assess scanning ability and psychomotor speed.

  • Change in performance on The Trail Making test part A [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making test part A, a test involving using lines to connect numbers, will be used to assess scanning ability and psychomotor speed.

  • Change in performance on the digit span subtest of the Weschler Adult Intelligence Scale - III [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    Short term memory will be evaluated with the digit span subtest of the Weschler Adult Intelligence Scale - III.

  • Change in performance on the digit span subtest of the Weschler Adult Intelligence Scale - III [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    Short term memory will be evaluated with the digit span subtest of the Weschler Adult Intelligence Scale - III.

  • Change in performance on the Trail Making Test Part B [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making Test, Part B, assesses Excutive Function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences.

  • Change in performance on Trail Making Part B [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    Trail Making Part B assesses Executive Functioning. It is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences.

  • Change in performance on the Wisconsin Card Sorting Test [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem-solving skills.

  • Change in performance on the Wisconsin Card Sorting Task [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem-solving skills.

  • Change in performance on The Digit Vigilance Test [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Digit Vigilance Test measures sustained attention/vigilance.

  • Change in performance on The Digit Vigilance Test. [ Time Frame: 6 months following assessment ] [ Designated as safety issue: No ]
    The Digit Vigilance Test measures sustained attention/vigilance.


Estimated Enrollment: 64
Study Start Date: December 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CR + Supported Education
Participants in this group will receive CR training in addition to supported education. CR has two components: computer-based cognitive exercise sessions held on a twice weekly basis for 10 weeks as well as 10 weekly group discussion sessions (approximately 60 minutes in duration).
 Behavioral: Cognitive Remediation
The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness. In addition to the supports available to all RTE students, this group will receive a total of twenty 45 minute computer-based cognitive exercise sessions held twice a week using COGPACK (Ver 6.0,www.cogpack.de). This program facilitates practice across a range of cognitive functions, including attention,psychomotor speed,memory, and executive functions. Participants will also take part in 10 weekly group discussion sessions,approximately 60 minutes in duration, focusing on strategies for management of symptoms and other cognitive deficits in an academic setting.
Other Name: CRT
Active Comparator: Supported Education Only
The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness (see http://www.georgebrown.ca/marketing/FTCal/access/C702.aspx for a full description). Participants in this arm will receive all services and supports provided by this program. However, they will not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
 Behavioral: Supported Education
Students enroll in credit courses, such as communications, computer skills, and the psychology of human relations which can lead to eligibility for post-secondary programs. Remedial skills in English, supervised study skills classes and other non-credit courses are included. Vocational testing is offered to help students determine their interests and aptitudes and students try out possible careers as well as their readiness to return to work by engaging in volunteer and work placements. Counsellors are also available to assist students in areas such as learning difficulties and coping with the stresses of school. The overarching goal of this program is to help students explore valued non-illness identities, build confidence, and re-engage with their communities.
Other Names:
  • SE
  • RTE
  • Redirection Through Education
  • Supported Education

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrollment in the George Brown Redirection Through Education program.
  • A DSM-IV chart diagnosis of schizophrenia or other psychotic condition
  • Stable use of medications for at least 3 months without plans of changing medications.
  • Proficiency in English.

Exclusion Criteria:

  • a psychiatric history of mental retardation, brain injury, or other neurological condition.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492439

Contacts
Contact: Sean A. Kidd, Ph.D. 416-535-8501 ext 6295 sean.kidd@camh.ca
Contact: Gursharan Virdee, M.Sc 416-535-8501 ext 4065 gursharan.virdee@camh.ca

Locations
Canada, Ontario
George Brown College Recruiting
Toronto, Ontario, Canada, M5T 2T9
Contact: Jaswant Kaur-Bajwa, Ph.D.     416-415-5000 ext 3575     jkaur@georgebrown.ca    
Sub-Investigator: Jaswant Kaur-Bajwa, Ph.D.            
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H1
Contact: Sean Kidd, Ph. D     4165358501 ext 6295     sean.kidd@camh.ca    
Contact: Gursharan Virdee, M.Sc     4165358501 ext 4065     gursharan.virdee@camh.ca    
Sub-Investigator: Kwame McKenzie, MD            
Sub-Investigator: Tony George, MD            
Sub-Investigator: Rohan Ganguli, MD            
Sponsors and Collaborators
Centre for Addiction and Mental Health
George Brown College
Investigators
Principal Investigator: Sean A. Kidd, Ph.D. Centre for Addiction and Mental Health
  More Information

Publications:

Responsible Party: Sean Kidd, Principal Investigator, Independent Clinician Scientist and Head of Psychology Services, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01492439     History of Changes
Other Study ID Numbers: 143/2011
Study First Received: December 13, 2011
Last Updated: December 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre for Addiction and Mental Health:
Psychosis
Psychosis NOS
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013