Effectiveness of Cognitive Remediation in a Supported Education Setting

This study has been completed.
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: June 10, 2014
Last verified: June 2014
  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:


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

Primary Outcome Measures:
  • Completion of Academic Semesters [ Time Frame: The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline) ] [ Designated as safety issue: No ]
    During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2. This data was used to determine whether completion of academic semesters might be explained by attending cognitive remediation alongside supported education. At the end of the each semester, course instructors notified the research team as to whether participants had completed or not completed the academic semester. The unit of measure, 'course completed' refers to the completion of the required number of courses in that academic semester to progress through to the next semester.


Secondary Outcome Measures:
  • Positive and Negative Symptoms Scale (PANSS) Score at 3 Months [ Time Frame: 3 months following baseline ] [ Designated as safety issue: No ]
    Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.

  • The Rosenberg Self-Esteem Scale Score at 3 Months [ Time Frame: 3 months following Baseline ] [ Designated as safety issue: No ]
    The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.

  • The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.

  • The Rosenberg Self-Esteem Scale Score at 6 Months [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.

  • The California Verbal Learning Test at 3 Months [ 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. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.

  • The California Verbal Learning Test at 6 Months [ 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. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.

  • The Trail Making Test Part A at 3 Months [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.

  • The Trail Making Test Part A at 6 Months [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.

  • The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months [ 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 Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.

  • The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months [ 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 Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.

  • The Trail Making Test Part B at 3 Months [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making Test Part B assesses executive 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. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.

  • The Trail Making Part B at 6 Months [ Time Frame: 6 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Trail Making Test Part B assesses executive 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. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.

  • The Wisconsin Card Sorting Test at 3 Months [ 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. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.

  • The Wisconsin Card Sorting Test at 3 Months [ 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. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.

  • The Wisconsin Card Sorting Task at 6 Months [ 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. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.

  • The Wisconsin Card Sorting Task at 6 Months [ 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. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.

  • The Digit Vigilance Test at 3 Months [ Time Frame: 3 months following Baseline assessment ] [ Designated as safety issue: No ]
    The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.

  • The Digit Vigilance Test at 3 Months [ Time Frame: 3 months following baseline assessment ] [ Designated as safety issue: No ]
    The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.

  • The Digit Vigilance Test at 6 Months [ Time Frame: 6 months following baseline assessment ] [ Designated as safety issue: No ]
    The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.


Enrollment: 37
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Remediation and Supported Education
Participants in this group will receive cognitive remediation training in addition to supported education. Cognitive remediation 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492439

Locations
Canada, Ontario
George Brown College
Toronto, Ontario, Canada, M5T 2T9
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H1
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
Results First Received: January 22, 2014
Last Updated: June 10, 2014
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 July 29, 2014