Psychosis
Conditions
Keywords
Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Brief summary
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.
Detailed description
Cognitive remediation is an intervention that has been found effective in reducing the degree of the cognitive problems experienced by persons with schizophrenia. Investigators are proposing a project that will examine the effectiveness of cognitive remediation in a supported education setting at George Brown College in Toronto, Ontario. This study would build upon a feasibility study that the investigators have recently completed and represents an emerging line of inquiry as these interventions are increasingly being tested in community rehabilitation settings. A large body of research has demonstrated the frequency of significant cognitive challenges among persons with schizophrenia who have ability levels that are, on average, 1-2 standard deviations lower than the general population in areas of problem solving, attention, and memory. These cognitive difficulties have been shown to have a marked impact on psychosocial functioning, making it very difficult to succeed for many people with schizophrenia in work and school settings. Work and school require people to prioritize, multi-task, sustain attention for prolonged periods, and remember material presented in a wide range of formats. Given the central role of education and employment in the recovery of persons with mental illness, it is crucial that efforts are made to address these cognitive difficulties to ensure the provision of a spectrum of services that can better address the quality of life of persons with schizophrenia. In the past 10 years there has been a rapidly increasing interest in the development of means through which the impact of cognitive deficits might be ameliorated for persons with psychosis. This body of work has concentrated largely upon cognitive remediation strategies. Cognitive remediation (CR) refers to interventions in which a range of cognitive tasks are repeatedly practiced to improve attention, memory, and problem solving abilities. Most of these interventions are computer based, typically set up in the form of games, and others are paper-and-pencil. Randomized controlled trials have consistently shown beneficial impacts of CR interventions on both cognitive and psychosocial functioning. Key findings include moderate effect sizes for improvements in attention, memory, and problem solving, more modest impacts on psychosocial functioning with better findings when CR is paired with supported employment. Less substantive impacts on psychosis symptomatology have been found, though self-esteem has been found to improve. Furthermore, the gains observed in CR have been found to be sustained for periods of up to 2 years post-intervention. Examination of non-specific effects has also indicated that CR leads to significant benefit over and above tasks that capture non-specific factors (e.g., computer skills training). In general there has been a clear shift in the cognitive remediation literature towards examining functional outcomes and pairing cognitive remediation with other psychosocial interventions. This movement likely builds from criticisms of the narrow scope of earlier cognitive remediation studies which looked only at pre and post measures of cognitive functioning and their questionable association with 'real world' outcomes. In response to these criticisms Susan McGurk pioneered the examination of CR in supported employment contexts. To date, however, outside of the work of the present investigators, no studies of CR in supported education settings have been found. Research in this area is important because (1) education is a core component of the recoveries of people with severe mental illness and (2) cognitive impairments markedly limit what people might achieve in education settings. Given the repeated calls in the literature for more randomized trials of cognitive remediation and the interest in the outcomes when partnered with psychosocial rehabilitation, this study addresses the following question: 'Does cognitive remediation as an adjunct to supported education result in improved cognitive functioning, symptoms, and performance in academic domains for persons with psychosis?' This study will employ a randomized design in which term 1 students with psychosis will be randomized into either supported education alone (SE; n = 8) or supported education and cognitive remediation combined (SE + CR; n = 8). The cognitive remediation intervention will have two components that will be completed over the course of 10 weeks within the academic term. First, participants will take part in a total of 20, 45 minute computer-based cognitive exercise sessions held on a twice weekly basis using COGPACK. This computer program facilitates practice across a broad range of cognitive functions, including attention and concentration, psychomotor speed, learning and memory, and executive functions. Participants will receive assistance on how to complete the cognitive exercises and will be given suggestions about strategies for improving performance on challenging exercises. In addition to computer exercises, participants will take part in 10 weekly group discussion sessions (approximately 60 minutes in duration). Topics in the group will include the role of cognitive factors in academic performance, the development of compensatory strategies for dealing with challenges in academic settings (e.g., study strategies, means of addressing attention difficulties), and strategies for managing difficulties such as anxiety and psychosis symptoms in school settings. Evaluations will be completed at pre-intervention/control, post-intervention/control and 3 month follow up for both groups. The above sequence will be completed over the course of 5 academic terms to allow for a total sample of 64 (term 1 students are enrolled in every academic term and the 5th term would just be follow-up for the 4th group). Each trial within the academic term will be 10 weeks in length to allow for pre and post testing to take place within the term.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALSupported 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.
Sponsors
George Brown College
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Academic Semesters | The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Rosenberg Self-Esteem Scale Score at 3 Months | 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. |
| The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | 6 months following Baseline assessment | 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 | 6 months following Baseline assessment | 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 | 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. |
| The California Verbal Learning Test at 6 Months | 6 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. |
| The Trail Making Test Part A at 3 Months | 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. |
| The Trail Making Test Part A at 6 Months | 6 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. |
| Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | 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. |
| The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | 6 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. |
| The Trail Making Test Part B at 3 Months | 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. |
| The Trail Making Part B at 6 Months | 6 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. |
| The Wisconsin Card Sorting Test at 3 Months | 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. |
| The Wisconsin Card Sorting Task at 6 Months | 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 the 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 | 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. |
| The Digit Vigilance Test at 6 Months | 6 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. |
| The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes). | 19 |
| 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. | 18 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrew from RTE | 4 | 9 |
Baseline characteristics
| Characteristic | Cognitive Remediation + Supported Education | Supported Education Only | Total |
|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 12.3 | 34.7 years STANDARD_DEVIATION 9.5 | 34.2 years STANDARD_DEVIATION 10.9 |
| English as a second language No | 14 participants | 11 participants | 25 participants |
| English as a second language Yes | 5 participants | 7 participants | 12 participants |
| Hospitalized as a result of diagnosis No | 4 participants | 9 participants | 13 participants |
| Hospitalized as a result of diagnosis Yes | 15 participants | 9 participants | 24 participants |
| Hours/week spent Competitive Employment | 1.7 hours per week STANDARD_DEVIATION 4.3 | 3.0 hours per week STANDARD_DEVIATION 6.9 | 2.4 hours per week STANDARD_DEVIATION 5.7 |
| Hours/week spent Student | 19.1 hours per week STANDARD_DEVIATION 1.5 | 19.7 hours per week STANDARD_DEVIATION 1.2 | 19.4 hours per week STANDARD_DEVIATION 1.3 |
| Hours/week spent Total hours engaged in meaningful activity | 21.8 hours per week STANDARD_DEVIATION 5 | 24.5 hours per week STANDARD_DEVIATION 7.1 | 23.1 hours per week STANDARD_DEVIATION 6.2 |
| Hours/week spent Volunteer | 0.9 hours per week STANDARD_DEVIATION 2.1 | 1.7 hours per week STANDARD_DEVIATION 3.7 | 1.3 hours per week STANDARD_DEVIATION 3 |
| Housing Live with family | 10 participants | 6 participants | 16 participants |
| Housing Own/rent apartment or house | 5 participants | 6 participants | 11 participants |
| Housing Shelter or other temporary residence | 1 participants | 2 participants | 3 participants |
| Housing Supported housing e.g. boarding home | 3 participants | 4 participants | 7 participants |
| Performance on the California Verbal Learning Test Long delay free recall | 6.00 Correct responses STANDARD_DEVIATION 1.7 | 5.61 Correct responses STANDARD_DEVIATION 1.46 | 5.81 Correct responses STANDARD_DEVIATION 1.58 |
| Performance on the California Verbal Learning Test Total free recall (trials 1-4) | 23.47 Correct responses STANDARD_DEVIATION 4.13 | 23.50 Correct responses STANDARD_DEVIATION 3.28 | 23.49 Correct responses STANDARD_DEVIATION 3.69 |
| Performance on the California Verbal Learning Test Trial 1 | 4.47 Correct responses STANDARD_DEVIATION 1.35 | 4.50 Correct responses STANDARD_DEVIATION 0.79 | 4.49 Correct responses STANDARD_DEVIATION 1.1 |
| Performance on the digit span subtest of the Wechsler Adult Intelligence Scale -III Backward sequence | 5.18 Correct responses STANDARD_DEVIATION 2.22 | 6.17 Correct responses STANDARD_DEVIATION 1.62 | 5.78 Correct responses STANDARD_DEVIATION 1.97 |
| Performance on the digit span subtest of the Wechsler Adult Intelligence Scale -III Forward sequence | 9.58 Correct responses STANDARD_DEVIATION 2.52 | 10.61 Correct responses STANDARD_DEVIATION 2.3 | 10.08 Correct responses STANDARD_DEVIATION 2.44 |
| Performance on the digit span subtest of the Wechsler Adult Intelligence Scale -III Total | 14.74 Correct responses STANDARD_DEVIATION 4.24 | 16.78 Correct responses STANDARD_DEVIATION 3.08 | 15.73 Correct responses STANDARD_DEVIATION 3.81 |
| Performance on The Digit Vigilance Test | 8.42 Incorrect responses STANDARD_DEVIATION 6.59 | 6.72 Incorrect responses STANDARD_DEVIATION 4.79 | 446.14 Seconds STANDARD_DEVIATION 111.01 |
| Performance on the Trail Making Test Part A | 49.00 Seconds STANDARD_DEVIATION 37.48 | 39.33 Seconds STANDARD_DEVIATION 15.96 | 44.30 Seconds STANDARD_DEVIATION 29.1 |
| Performance on the Trail Making Test Part B | 98.68 Seconds STANDARD_DEVIATION 57.58 | 92.83 Seconds STANDARD_DEVIATION 42.93 | 95.84 Seconds STANDARD_DEVIATION 50.33 |
| Performance on the Wisconsin Card Sorting Test | 36.37 Total categories STANDARD_DEVIATION 11.98 | 40.55 Total categories STANDARD_DEVIATION 7.82 | 38.41 Total categories STANDARD_DEVIATION 10.26 |
| Performance on the Wisconsin Card Sorting Test (WCST) % conceptual level of responses | 41.95 Percentage of responses STANDARD_DEVIATION 26.2 | 52.94 Percentage of responses STANDARD_DEVIATION 16.74 | 47.30 Percentage of responses STANDARD_DEVIATION 22.51 |
| Performance on the Wisconsin Card Sorting Test (WCST) % perseverative errors | 19.79 Percentage of responses STANDARD_DEVIATION 12.23 | 18.94 Percentage of responses STANDARD_DEVIATION 8.54 | 19.38 Percentage of responses STANDARD_DEVIATION 10.46 |
| Positive and Negative Syndrome Scale (PANSS) score General psychopathology | 27.21 units on a scale STANDARD_DEVIATION 6.87 | 28.33 units on a scale STANDARD_DEVIATION 5.89 | 27.76 units on a scale STANDARD_DEVIATION 6.35 |
| Positive and Negative Syndrome Scale (PANSS) score Negative | 13.42 units on a scale STANDARD_DEVIATION 4.03 | 14.56 units on a scale STANDARD_DEVIATION 4.95 | 13.97 units on a scale STANDARD_DEVIATION 4.48 |
| Positive and Negative Syndrome Scale (PANSS) score Positive | 13.58 units on a scale STANDARD_DEVIATION 6.43 | 13.06 units on a scale STANDARD_DEVIATION 3.95 | 13.32 units on a scale STANDARD_DEVIATION 5.3 |
| Primary diagnosis Bipolar | 5 participants | 2 participants | 7 participants |
| Primary diagnosis Psychosis NOS (Not otherwise specified) | 2 participants | 4 participants | 6 participants |
| Primary diagnosis Schizoaffective | 1 participants | 2 participants | 3 participants |
| Primary diagnosis Schizophrenia | 11 participants | 10 participants | 21 participants |
| Race/Ethnicity, Customized Asian East | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Asian South | 4 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Black Canadian | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Black Caribbean | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Mixed Background | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants | 5 participants | 6 participants |
| Race/Ethnicity, Customized White European Origin | 7 participants | 5 participants | 12 participants |
| Region of Enrollment Canada | 19 participants | 18 participants | 37 participants |
| Self assessed level of competency in English Advanced | 8 participants | 3 participants | 11 participants |
| Self assessed level of competency in English Beginner | 2 participants | 0 participants | 2 participants |
| Self assessed level of competency in English Intermediate | 9 participants | 15 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
| The Rosenberg Self-Esteem Scale Score | 19.16 units on a scale STANDARD_DEVIATION 4.63 | 17.39 units on a scale STANDARD_DEVIATION 4.7 | 18.30 units on a scale STANDARD_DEVIATION 4.69 |
| Years of education | 11.9 years STANDARD_DEVIATION 1.2 | 13.2 years STANDARD_DEVIATION 1.9 | 12.5 years STANDARD_DEVIATION 1.7 |
| Years since diagnosis | 6.7 years STANDARD_DEVIATION 6.5 | 7.0 years STANDARD_DEVIATION 5.5 | 6.9 years STANDARD_DEVIATION 5.9 |
| Years since last hospitalization | 3.2 years STANDARD_DEVIATION 4.5 | 1.7 years STANDARD_DEVIATION 2.9 | 2.5 years STANDARD_DEVIATION 3.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Completion of Academic Semesters
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.
Time frame: The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | Completion of Academic Semesters | Semester 1 | 1.95 Courses completed | Standard Deviation 0.29 |
| Cognitive Remediation + Supported Education | Completion of Academic Semesters | Semester 2 | 1.89 Courses completed | Standard Deviation 0.375 |
| Supported Education Only | Completion of Academic Semesters | Semester 1 | 1.67 Courses completed | Standard Deviation 0.48 |
| Supported Education Only | Completion of Academic Semesters | Semester 2 | 1.67 Courses completed | Standard Deviation 0.485 |
p-value: 0.029t-test, 1 sided
p-value: 0.225t-test, 1 sided
Secondary
Positive and Negative Symptoms Scale (PANSS) Score at 3 Months
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.
Time frame: 3 months following baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | Positive scale | 13.22 units on a scale | Standard Deviation 5.32 |
| Cognitive Remediation + Supported Education | Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | Negative scale | 12.83 units on a scale | Standard Deviation 5.5 |
| Cognitive Remediation + Supported Education | Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | General psychopathology scale | 27.89 units on a scale | Standard Deviation 6.43 |
| Supported Education Only | Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | Positive scale | 13.90 units on a scale | Standard Deviation 5.87 |
| Supported Education Only | Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | Negative scale | 14.31 units on a scale | Standard Deviation 4.25 |
| Supported Education Only | Positive and Negative Symptoms Scale (PANSS) Score at 3 Months | General psychopathology scale | 29.23 units on a scale | Standard Deviation 7.81 |
p-value: 0.247ANCOVA
p-value: 0.747ANCOVA
p-value: 0.582ANCOVA
Secondary
The California Verbal Learning Test at 3 Months
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.
Time frame: 3 months following Baseline Assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The California Verbal Learning Test at 3 Months | Trial 1 | 5.83 Correct responses | Standard Deviation 1.42 |
| Cognitive Remediation + Supported Education | The California Verbal Learning Test at 3 Months | Total free recall (Trials 1-4) | 28.28 Correct responses | Standard Deviation 4.2 |
| Cognitive Remediation + Supported Education | The California Verbal Learning Test at 3 Months | Long delay free recall | 7.22 Correct responses | Standard Deviation 1.26 |
| Supported Education Only | The California Verbal Learning Test at 3 Months | Trial 1 | 5.23 Correct responses | Standard Deviation 1.54 |
| Supported Education Only | The California Verbal Learning Test at 3 Months | Total free recall (Trials 1-4) | 26.08 Correct responses | Standard Deviation 4.03 |
| Supported Education Only | The California Verbal Learning Test at 3 Months | Long delay free recall | 6.92 Correct responses | Standard Deviation 1.12 |
p-value: 0.314ANCOVA
p-value: 0.669ANCOVA
p-value: 0.242ANCOVA
Secondary
The California Verbal Learning Test at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The California Verbal Learning Test at 6 Months | Trial 1 | 6.00 Correct responses | Standard Deviation 1.69 |
| Cognitive Remediation + Supported Education | The California Verbal Learning Test at 6 Months | Total free recall (Trials 1-4) | 28.60 Correct responses | Standard Deviation 4.6 |
| Cognitive Remediation + Supported Education | The California Verbal Learning Test at 6 Months | Long delay free recall | 7.40 Correct responses | Standard Deviation 1.64 |
| Supported Education Only | The California Verbal Learning Test at 6 Months | Trial 1 | 5.00 Correct responses | Standard Deviation 1.12 |
| Supported Education Only | The California Verbal Learning Test at 6 Months | Total free recall (Trials 1-4) | 26.44 Correct responses | Standard Deviation 2.4 |
| Supported Education Only | The California Verbal Learning Test at 6 Months | Long delay free recall | 7.44 Correct responses | Standard Deviation 0.53 |
p-value: 0.139ANCOVA
p-value: 0.269ANCOVA
p-value: 0.666ANCOVA
Secondary
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months
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.
Time frame: 3 months following Baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | Forward | 9.05 Correct responses | Standard Deviation 2.09 |
| Cognitive Remediation + Supported Education | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | Backward | 5.22 Correct responses | Standard Deviation 2.2 |
| Cognitive Remediation + Supported Education | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | Total | 14.28 Correct responses | Standard Deviation 3.75 |
| Supported Education Only | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | Forward | 9.07 Correct responses | Standard Deviation 1.32 |
| Supported Education Only | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | Backward | 5.23 Correct responses | Standard Deviation 1.36 |
| Supported Education Only | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months | Total | 14.31 Correct responses | Standard Deviation 1.89 |
p-value: 0.531ANCOVA
p-value: 0.754ANCOVA
p-value: 0.518ANCOVA
Secondary
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | Forward | 9.73 Correct responses | Standard Deviation 2.25 |
| Cognitive Remediation + Supported Education | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | Backward | 6.60 Correct responses | Standard Deviation 2.5 |
| Cognitive Remediation + Supported Education | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | Total | 16.33 Correct responses | Standard Deviation 4.32 |
| Supported Education Only | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | Forward | 9.67 Correct responses | Standard Deviation 2.45 |
| Supported Education Only | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | Backward | 5.78 Correct responses | Standard Deviation 1.99 |
| Supported Education Only | The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months | Total | 15.22 Correct responses | Standard Deviation 4.18 |
p-value: 0.802ANCOVA
p-value: 0.091ANCOVA
p-value: 0.171ANCOVA
Secondary
The Digit Vigilance Test at 3 Months
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.
Time frame: 3 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Digit Vigilance Test at 3 Months | 8.33 Incorrect Responses | Standard Deviation 8.7 |
| Supported Education Only | The Digit Vigilance Test at 3 Months | 10.54 Incorrect Responses | Standard Deviation 8.67 |
p-value: 0.129ANCOVA
Secondary
The Digit Vigilance Test at 3 Months
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.
Time frame: 3 months following baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Digit Vigilance Test at 3 Months | 446.11 Seconds | Standard Deviation 111.97 |
| Supported Education Only | The Digit Vigilance Test at 3 Months | 366.61 Seconds | Standard Deviation 43.58 |
Comparison: This applies to the total time taken to complete the DVT.p-value: 0.004ANCOVA
Secondary
The Digit Vigilance Test at 6 Months
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.
Time frame: 6 months following baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Digit Vigilance Test at 6 Months | 409.93 Seconds | Standard Deviation 89.16 |
| Supported Education Only | The Digit Vigilance Test at 6 Months | 433.33 Seconds | Standard Deviation 74.2 |
Comparison: This applies to the total time taken to complete the DVT.p-value: 0.468ANCOVA
Secondary
The Digit Vigilance Test at 6 Months
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.
Time frame: 6 months following baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Digit Vigilance Test at 6 Months | 5.60 Incorrect Responses | Standard Deviation 3.7 |
| Supported Education Only | The Digit Vigilance Test at 6 Months | 5.22 Incorrect Responses | Standard Deviation 5.07 |
p-value: 0.853ANCOVA
Secondary
The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | Positive scale | 14.40 units on a scale | Standard Deviation 6.27 |
| Cognitive Remediation + Supported Education | The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | Negative scale | 11.53 units on a scale | Standard Deviation 2.13 |
| Cognitive Remediation + Supported Education | The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | General psychopathology scale | 26.20 units on a scale | Standard Deviation 6.68 |
| Supported Education Only | The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | Positive scale | 13.44 units on a scale | Standard Deviation 5.64 |
| Supported Education Only | The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | Negative scale | 17.44 units on a scale | Standard Deviation 6.02 |
| Supported Education Only | The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months | General psychopathology scale | 28.44 units on a scale | Standard Deviation 7.62 |
p-value: 0.95ANCOVA
p-value: 0.027ANCOVA
p-value: 0.639ANCOVA
Secondary
The Rosenberg Self-Esteem Scale Score at 3 Months
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.
Time frame: 3 months following Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Rosenberg Self-Esteem Scale Score at 3 Months | 21.72 units on a scale | Standard Deviation 3.75 |
| Supported Education Only | The Rosenberg Self-Esteem Scale Score at 3 Months | 15.31 units on a scale | Standard Deviation 3.97 |
p-value: 0ANCOVA
Secondary
The Rosenberg Self-Esteem Scale Score at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Rosenberg Self-Esteem Scale Score at 6 Months | 21.53 units on a scale | Standard Deviation 4.31 |
| Supported Education Only | The Rosenberg Self-Esteem Scale Score at 6 Months | 16.00 units on a scale | Standard Deviation 4.95 |
p-value: 0.008ANCOVA
Secondary
The Trail Making Part B at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Trail Making Part B at 6 Months | 88.58 Seconds | Standard Deviation 66.98 |
| Supported Education Only | The Trail Making Part B at 6 Months | 70.22 Seconds | Standard Deviation 24.63 |
p-value: 0.527ANCOVA
Secondary
The Trail Making Test Part A at 3 Months
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.
Time frame: 3 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Trail Making Test Part A at 3 Months | 33.89 Seconds | Standard Deviation 16.73 |
| Supported Education Only | The Trail Making Test Part A at 3 Months | 27.08 Seconds | Standard Deviation 6.71 |
p-value: 0.391ANCOVA
Secondary
The Trail Making Test Part A at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Trail Making Test Part A at 6 Months | 33.20 Seconds | Standard Deviation 16.21 |
| Supported Education Only | The Trail Making Test Part A at 6 Months | 31.00 Seconds | Standard Deviation 8.25 |
p-value: 0.958ANCOVA
Secondary
The Trail Making Test Part B at 3 Months
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.
Time frame: 3 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Trail Making Test Part B at 3 Months | 104.11 Seconds | Standard Deviation 73.32 |
| Supported Education Only | The Trail Making Test Part B at 3 Months | 81.31 Seconds | Standard Deviation 27.96 |
p-value: 0.267ANCOVA
Secondary
The Wisconsin Card Sorting Task at 6 Months
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.
Time frame: 6 months following Baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The Wisconsin Card Sorting Task at 6 Months | % perseverative errors | 21.27 Percentage of responses | Standard Deviation 14.32 |
| Cognitive Remediation + Supported Education | The Wisconsin Card Sorting Task at 6 Months | % conceptual level of responses | 49.67 Percentage of responses | Standard Deviation 26.18 |
| Supported Education Only | The Wisconsin Card Sorting Task at 6 Months | % perseverative errors | 16.00 Percentage of responses | Standard Deviation 10.39 |
| Supported Education Only | The Wisconsin Card Sorting Task at 6 Months | % conceptual level of responses | 53.78 Percentage of responses | Standard Deviation 33.04 |
p-value: 0.156ANCOVA
p-value: 0.926ANCOVA
Secondary
The Wisconsin Card Sorting Task at 6 Months
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.
Time frame: 6 months following baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Wisconsin Card Sorting Task at 6 Months | 39.87 Correct responses | Standard Deviation 12.36 |
| Supported Education Only | The Wisconsin Card Sorting Task at 6 Months | 41.33 Correct responses | Standard Deviation 15.12 |
Comparison: This applies to the total number of categories on the WCST.p-value: 0.843ANCOVA
Secondary
The Wisconsin Card Sorting Test at 3 Months
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.
Time frame: 3 months following Baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation + Supported Education | The Wisconsin Card Sorting Test at 3 Months | 40.00 Correct responses | Standard Deviation 13.32 |
| Supported Education Only | The Wisconsin Card Sorting Test at 3 Months | 44.38 Correct responses | Standard Deviation 9.39 |
p-value: 0.612ANCOVA
Secondary
The Wisconsin Card Sorting Test at 3 Months
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.
Time frame: 3 months following Baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation + Supported Education | The Wisconsin Card Sorting Test at 3 Months | % perseverative errors | 19.56 Percentage of responses | Standard Deviation 16.39 |
| Cognitive Remediation + Supported Education | The Wisconsin Card Sorting Test at 3 Months | % conceptual level of responses | 50.67 Percentage of responses | Standard Deviation 26.61 |
| Supported Education Only | The Wisconsin Card Sorting Test at 3 Months | % perseverative errors | 14.85 Percentage of responses | Standard Deviation 8.93 |
| Supported Education Only | The Wisconsin Card Sorting Test at 3 Months | % conceptual level of responses | 60.31 Percentage of responses | Standard Deviation 22.24 |
p-value: 0.852ANCOVA
p-value: 0.637ANCOVA