Trial Outcomes & Findings for Effectiveness of Cognitive Remediation in a Supported Education Setting (NCT NCT01492439)

Last Updated: 2014-06-11

Results Overview

During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2.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.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)

Results posted on

2014-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitive Remediation + Supported Education Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
Overall Study STARTED	19	18
Overall Study Post-intervention	18	13
Overall Study COMPLETED	15	9
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Remediation + Supported Education Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
Overall Study Withdrew from RTE	4	9

Baseline Characteristics

Effectiveness of Cognitive Remediation in a Supported Education Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Remediation + Supported Education n=19 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=18 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.	Total n=37 Participants Total of all reporting groups
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian East	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Asian South	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Black Canadian	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Age, Continuous	33.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	34.7 years STANDARD_DEVIATION 9.5 • n=7 Participants	34.2 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Black Caribbean	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Mixed Background	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized White European Origin	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Canada	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants
English as a second language Yes	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
English as a second language No	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants
Self assessed level of competency in English Beginner	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Self assessed level of competency in English Intermediate	9 participants n=5 Participants	15 participants n=7 Participants	24 participants n=5 Participants
Self assessed level of competency in English Advanced	8 participants n=5 Participants	3 participants n=7 Participants	11 participants n=5 Participants
Primary diagnosis Schizophrenia	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Primary diagnosis Schizoaffective	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Primary diagnosis Bipolar	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Primary diagnosis Psychosis NOS (Not otherwise specified)	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Hospitalized as a result of diagnosis Yes	15 participants n=5 Participants	9 participants n=7 Participants	24 participants n=5 Participants
Hospitalized as a result of diagnosis No	4 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants
Housing Own/rent apartment or house	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Housing Supported housing e.g. boarding home	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Housing Live with family	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Housing Shelter or other temporary residence	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Years of education	11.9 years STANDARD_DEVIATION 1.2 • n=5 Participants	13.2 years STANDARD_DEVIATION 1.9 • n=7 Participants	12.5 years STANDARD_DEVIATION 1.7 • n=5 Participants
Years since diagnosis	6.7 years STANDARD_DEVIATION 6.5 • n=5 Participants	7.0 years STANDARD_DEVIATION 5.5 • n=7 Participants	6.9 years STANDARD_DEVIATION 5.9 • n=5 Participants
Years since last hospitalization	3.2 years STANDARD_DEVIATION 4.5 • n=5 Participants	1.7 years STANDARD_DEVIATION 2.9 • n=7 Participants	2.5 years STANDARD_DEVIATION 3.8 • n=5 Participants
Hours/week spent Competitive Employment	1.7 hours per week STANDARD_DEVIATION 4.3 • n=5 Participants	3.0 hours per week STANDARD_DEVIATION 6.9 • n=7 Participants	2.4 hours per week STANDARD_DEVIATION 5.7 • n=5 Participants
Hours/week spent Student	19.1 hours per week STANDARD_DEVIATION 1.5 • n=5 Participants	19.7 hours per week STANDARD_DEVIATION 1.2 • n=7 Participants	19.4 hours per week STANDARD_DEVIATION 1.3 • n=5 Participants
Hours/week spent Volunteer	0.9 hours per week STANDARD_DEVIATION 2.1 • n=5 Participants	1.7 hours per week STANDARD_DEVIATION 3.7 • n=7 Participants	1.3 hours per week STANDARD_DEVIATION 3.0 • n=5 Participants
Hours/week spent Total hours engaged in meaningful activity	21.8 hours per week STANDARD_DEVIATION 5.0 • n=5 Participants	24.5 hours per week STANDARD_DEVIATION 7.1 • n=7 Participants	23.1 hours per week STANDARD_DEVIATION 6.2 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) score Positive	13.58 units on a scale STANDARD_DEVIATION 6.43 • n=5 Participants	13.06 units on a scale STANDARD_DEVIATION 3.95 • n=7 Participants	13.32 units on a scale STANDARD_DEVIATION 5.30 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) score Negative	13.42 units on a scale STANDARD_DEVIATION 4.03 • n=5 Participants	14.56 units on a scale STANDARD_DEVIATION 4.95 • n=7 Participants	13.97 units on a scale STANDARD_DEVIATION 4.48 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) score General psychopathology	27.21 units on a scale STANDARD_DEVIATION 6.87 • n=5 Participants	28.33 units on a scale STANDARD_DEVIATION 5.89 • n=7 Participants	27.76 units on a scale STANDARD_DEVIATION 6.35 • n=5 Participants
The Rosenberg Self-Esteem Scale Score	19.16 units on a scale STANDARD_DEVIATION 4.63 • n=5 Participants	17.39 units on a scale STANDARD_DEVIATION 4.70 • n=7 Participants	18.30 units on a scale STANDARD_DEVIATION 4.69 • n=5 Participants
Performance on the California Verbal Learning Test Trial 1	4.47 Correct responses STANDARD_DEVIATION 1.35 • n=5 Participants	4.50 Correct responses STANDARD_DEVIATION 0.79 • n=7 Participants	4.49 Correct responses STANDARD_DEVIATION 1.10 • n=5 Participants
Performance on the California Verbal Learning Test Total free recall (trials 1-4)	23.47 Correct responses STANDARD_DEVIATION 4.13 • n=5 Participants	23.50 Correct responses STANDARD_DEVIATION 3.28 • n=7 Participants	23.49 Correct responses STANDARD_DEVIATION 3.69 • n=5 Participants
Performance on the California Verbal Learning Test Long delay free recall	6.00 Correct responses STANDARD_DEVIATION 1.70 • n=5 Participants	5.61 Correct responses STANDARD_DEVIATION 1.46 • n=7 Participants	5.81 Correct responses STANDARD_DEVIATION 1.58 • n=5 Participants
Performance on the Trail Making Test Part A	49.00 Seconds STANDARD_DEVIATION 37.48 • n=5 Participants	39.33 Seconds STANDARD_DEVIATION 15.96 • n=7 Participants	44.30 Seconds STANDARD_DEVIATION 29.10 • n=5 Participants
Performance on the digit span subtest of the Wechsler Adult Intelligence Scale -III Forward sequence	9.58 Correct responses STANDARD_DEVIATION 2.52 • n=5 Participants	10.61 Correct responses STANDARD_DEVIATION 2.30 • n=7 Participants	10.08 Correct responses STANDARD_DEVIATION 2.44 • n=5 Participants
Performance on the digit span subtest of the Wechsler Adult Intelligence Scale -III Backward sequence	5.18 Correct responses STANDARD_DEVIATION 2.22 • n=5 Participants	6.17 Correct responses STANDARD_DEVIATION 1.62 • n=7 Participants	5.78 Correct responses STANDARD_DEVIATION 1.97 • n=5 Participants
Performance on the digit span subtest of the Wechsler Adult Intelligence Scale -III Total	14.74 Correct responses STANDARD_DEVIATION 4.24 • n=5 Participants	16.78 Correct responses STANDARD_DEVIATION 3.08 • n=7 Participants	15.73 Correct responses STANDARD_DEVIATION 3.81 • n=5 Participants
Performance on the Trail Making Test Part B	98.68 Seconds STANDARD_DEVIATION 57.58 • n=5 Participants	92.83 Seconds STANDARD_DEVIATION 42.93 • n=7 Participants	95.84 Seconds STANDARD_DEVIATION 50.33 • n=5 Participants
Performance on the Wisconsin Card Sorting Test (WCST) % perseverative errors	19.79 Percentage of responses STANDARD_DEVIATION 12.23 • n=5 Participants	18.94 Percentage of responses STANDARD_DEVIATION 8.54 • n=7 Participants	19.38 Percentage of responses STANDARD_DEVIATION 10.46 • n=5 Participants
Performance on the Wisconsin Card Sorting Test (WCST) % conceptual level of responses	41.95 Percentage of responses STANDARD_DEVIATION 26.20 • n=5 Participants	52.94 Percentage of responses STANDARD_DEVIATION 16.74 • n=7 Participants	47.30 Percentage of responses STANDARD_DEVIATION 22.51 • n=5 Participants
Performance on The Digit Vigilance Test	8.42 Incorrect responses STANDARD_DEVIATION 6.59 • n=5 Participants	6.72 Incorrect responses STANDARD_DEVIATION 4.79 • n=7 Participants	7.59 Incorrect responses STANDARD_DEVIATION 5.77 • n=5 Participants
Performance on the Wisconsin Card Sorting Test	36.37 Total categories STANDARD_DEVIATION 11.98 • n=5 Participants	40.55 Total categories STANDARD_DEVIATION 7.82 • n=7 Participants	38.41 Total categories STANDARD_DEVIATION 10.26 • n=5 Participants

PRIMARY outcome

Timeframe: The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=19 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=18 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
Completion of Academic Semesters Semester 1	1.95 Courses completed Standard Deviation 0.29	1.67 Courses completed Standard Deviation 0.48
Completion of Academic Semesters Semester 2	1.89 Courses completed Standard Deviation 0.375	1.67 Courses completed Standard Deviation 0.485

SECONDARY outcome

Timeframe: 3 months following baseline

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
Positive and Negative Symptoms Scale (PANSS) Score at 3 Months Positive scale	13.22 units on a scale Standard Deviation 5.32	13.90 units on a scale Standard Deviation 5.87
Positive and Negative Symptoms Scale (PANSS) Score at 3 Months Negative scale	12.83 units on a scale Standard Deviation 5.50	14.31 units on a scale Standard Deviation 4.25
Positive and Negative Symptoms Scale (PANSS) Score at 3 Months General psychopathology scale	27.89 units on a scale Standard Deviation 6.43	29.23 units on a scale Standard Deviation 7.81

SECONDARY outcome

Timeframe: 3 months following Baseline

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Rosenberg Self-Esteem Scale Score at 3 Months	21.72 units on a scale Standard Deviation 3.75	15.31 units on a scale Standard Deviation 3.97

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months Positive scale	14.40 units on a scale Standard Deviation 6.27	13.44 units on a scale Standard Deviation 5.64
The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months Negative scale	11.53 units on a scale Standard Deviation 2.13	17.44 units on a scale Standard Deviation 6.02
The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months General psychopathology scale	26.20 units on a scale Standard Deviation 6.68	28.44 units on a scale Standard Deviation 7.62

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Rosenberg Self-Esteem Scale Score at 6 Months	21.53 units on a scale Standard Deviation 4.31	16.00 units on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: 3 months following Baseline Assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The California Verbal Learning Test at 3 Months Trial 1	5.83 Correct responses Standard Deviation 1.42	5.23 Correct responses Standard Deviation 1.54
The California Verbal Learning Test at 3 Months Total free recall (Trials 1-4)	28.28 Correct responses Standard Deviation 4.20	26.08 Correct responses Standard Deviation 4.03
The California Verbal Learning Test at 3 Months Long delay free recall	7.22 Correct responses Standard Deviation 1.26	6.92 Correct responses Standard Deviation 1.12

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The California Verbal Learning Test at 6 Months Trial 1	6.00 Correct responses Standard Deviation 1.69	5.00 Correct responses Standard Deviation 1.12
The California Verbal Learning Test at 6 Months Total free recall (Trials 1-4)	28.60 Correct responses Standard Deviation 4.60	26.44 Correct responses Standard Deviation 2.40
The California Verbal Learning Test at 6 Months Long delay free recall	7.40 Correct responses Standard Deviation 1.64	7.44 Correct responses Standard Deviation 0.53

SECONDARY outcome

Timeframe: 3 months following Baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Trail Making Test Part A at 3 Months	33.89 Seconds Standard Deviation 16.73	27.08 Seconds Standard Deviation 6.71

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Trail Making Test Part A at 6 Months	33.20 Seconds Standard Deviation 16.21	31.00 Seconds Standard Deviation 8.25

SECONDARY outcome

Timeframe: 3 months following Baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months Forward	9.05 Correct responses Standard Deviation 2.09	9.07 Correct responses Standard Deviation 1.32
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months Backward	5.22 Correct responses Standard Deviation 2.20	5.23 Correct responses Standard Deviation 1.36
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months Total	14.28 Correct responses Standard Deviation 3.75	14.31 Correct responses Standard Deviation 1.89

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months Forward	9.73 Correct responses Standard Deviation 2.25	9.67 Correct responses Standard Deviation 2.45
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months Backward	6.60 Correct responses Standard Deviation 2.50	5.78 Correct responses Standard Deviation 1.99
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months Total	16.33 Correct responses Standard Deviation 4.32	15.22 Correct responses Standard Deviation 4.18

SECONDARY outcome

Timeframe: 3 months following Baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Trail Making Test Part B at 3 Months	104.11 Seconds Standard Deviation 73.32	81.31 Seconds Standard Deviation 27.96

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Trail Making Part B at 6 Months	88.58 Seconds Standard Deviation 66.98	70.22 Seconds Standard Deviation 24.63

SECONDARY outcome

Timeframe: 3 months following Baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Wisconsin Card Sorting Test at 3 Months % perseverative errors	19.56 Percentage of responses Standard Deviation 16.39	14.85 Percentage of responses Standard Deviation 8.93
The Wisconsin Card Sorting Test at 3 Months % conceptual level of responses	50.67 Percentage of responses Standard Deviation 26.61	60.31 Percentage of responses Standard Deviation 22.24

SECONDARY outcome

Timeframe: 3 months following Baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Wisconsin Card Sorting Test at 3 Months	40.00 Correct responses Standard Deviation 13.32	44.38 Correct responses Standard Deviation 9.39

SECONDARY outcome

Timeframe: 6 months following Baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Wisconsin Card Sorting Task at 6 Months % perseverative errors	21.27 Percentage of responses Standard Deviation 14.32	16.00 Percentage of responses Standard Deviation 10.39
The Wisconsin Card Sorting Task at 6 Months % conceptual level of responses	49.67 Percentage of responses Standard Deviation 26.18	53.78 Percentage of responses Standard Deviation 33.04

SECONDARY outcome

Timeframe: 6 months following baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Wisconsin Card Sorting Task at 6 Months	39.87 Correct responses Standard Deviation 12.36	41.33 Correct responses Standard Deviation 15.12

SECONDARY outcome

Timeframe: 3 months following Baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Digit Vigilance Test at 3 Months	8.33 Incorrect Responses Standard Deviation 8.70	10.54 Incorrect Responses Standard Deviation 8.67

SECONDARY outcome

Timeframe: 3 months following baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=18 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=13 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Digit Vigilance Test at 3 Months	446.11 Seconds Standard Deviation 111.97	366.61 Seconds Standard Deviation 43.58

SECONDARY outcome

Timeframe: 6 months following baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Digit Vigilance Test at 6 Months	5.60 Incorrect Responses Standard Deviation 3.70	5.22 Incorrect Responses Standard Deviation 5.07

SECONDARY outcome

Timeframe: 6 months following baseline assessment

Outcome measures

Outcome measures
Measure	Cognitive Remediation + Supported Education n=15 Participants Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).	Supported Education Only n=9 Participants Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
The Digit Vigilance Test at 6 Months	409.93 Seconds Standard Deviation 89.16	433.33 Seconds Standard Deviation 74.2

Adverse Events

Cognitive Remediation + Supported Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Supported Education Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sean A. Kidd

Centre for Addiction and Mental Health

Phone: 416-535-8501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place