PsychosisNCT01492439
Effectiveness of Cognitive Remediation in a Supported Education Setting
A study testing Cognitive Remediation and Supported Education in people with Psychosis, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive Remediation and Supported Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- a psychiatric history of mental retardation, brain injury, or other neurological condition.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
George Brown College
Toronto, Ontario, M5T 2T9
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H1
About this study
Official title: Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting
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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- Cognitive Remediation, Supported Education
- Keywords
- Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
Also called CRT
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.
Supported EducationBehavioural
Also called SE, RTE, Redirection Through 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation and Supported Education | Experimental | Participants in this group will receive cognitive remediation training in addition to supported education. Cognitive remediation has two components: computer-based cognitive exercise sessions held on a twice weekly basis for 10 weeks as well as 10 weekly group discussion sessions (approximately 60 minutes in duration). Receives: Behavioral: Cognitive Remediation |
| Supported Education Only | Active comparator | The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness (see http://www.georgebrown.ca/marketing/FTCal/access/C702.aspx for a full description). Participants in this arm will receive all services and supports provided by this program. However, they will not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study. Receives: Behavioral: Supported Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)
Secondary outcomes (18)
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.
Measured: 3 months following baseline
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.
Measured: 3 months following Baseline
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.
Measured: 6 months following Baseline assessment
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.
Measured: 6 months following Baseline assessment
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.
Measured: 3 months following Baseline Assessment
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.
Measured: 6 months following Baseline assessment
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.
Measured: 3 months following Baseline assessment
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.
Measured: 6 months following Baseline assessment
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.
Measured: 3 months following Baseline assessment
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.
Measured: 6 months following Baseline assessment
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.
Measured: 3 months following Baseline assessment
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.
Measured: 6 months following Baseline assessment
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.
Measured: 3 months following Baseline assessment
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.
Measured: 3 months following Baseline assessment
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.
Measured: 6 months following Baseline assessment
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.
Measured: 6 months following baseline assessment
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.
Measured: 3 months following Baseline assessment
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.
Measured: 6 months following baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- George Brown College
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
- Investigators
- Sean A. Kidd, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492439
- Sponsor's protocol ID
- 143/2011
- Status last verified
- Jun 2014
- First submitted
- 13 Dec 2011
- Last updated
- 11 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Anthony WA. Cognitive remediation and psychiatric rehabilitation. Psychiatr Rehabil J. 2008 Fall;32(2):87-8. doi: 10.2975/32.2.2008.87.88. No abstract available.
PubMed 18840561Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
PubMed 11483142BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. doi: 10.1080/00221309.1948.9918159. No abstract available.
PubMed 18889466Davidson, L. (2003). Living Outside Mental Illness: Qualitative Studies of Recovery in Schizophrenia. New York City, NY: New York University Press.
Delis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.
Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.
PubMed 16368053Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.
PubMed 15531406Health Canada. (2002). A Report on Mental Illnesses in Canada. Ottawa: Health Canada.
Hodge MA, Siciliano D, Withey P, Moss B, Moore G, Judd G, Shores EA, Harris A. A randomized controlled trial of cognitive remediation in schizophrenia. Schizophr Bull. 2010 Mar;36(2):419-27. doi: 10.1093/schbul/sbn102. Epub 2008 Aug 20.
PubMed 18718884Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44.
PubMed 14588938Kurtz MM, Seltzer JC, Fujimoto M, Shagan DS, Wexler BE. Predictors of change in life skills in schizophrenia after cognitive remediation. Schizophr Res. 2009 Feb;107(2-3):267-74. doi: 10.1016/j.schres.2008.10.014. Epub 2008 Nov 8.
PubMed 19006657Kurtz MM, Seltzer JC, Shagan DS, Thime WR, Wexler BE. Computer-assisted cognitive remediation in schizophrenia: what is the active ingredient? Schizophr Res. 2007 Jan;89(1-3):251-60. doi: 10.1016/j.schres.2006.09.001. Epub 2006 Oct 27.
PubMed 17070671McGrew JH, Johannesen JK, Griss ME, Born DL, Katuin CH. Performance-based funding of supported employment for persons with severe mental illness: vocational rehabilitation and employment staff perspectives. J Behav Health Serv Res. 2007 Jan;34(1):1-16. doi: 10.1007/s11414-006-9045-z. Epub 2006 Dec 19.
PubMed 17180719Lezak, M. D. (1995). Neuropsychological Assessment. New York: Oxford University.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting
- ClinicalTrials.gov ID
- NCT01492439
- Acronym / sponsor ID
- 143/2011
- Conditions
- Psychosis
- Keywords
- Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- George Brown College
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation and Supported Education | Experimental | Behavioral: Cognitive RemediationParticipants in this group will receive cognitive remediation training in addition to supported education. Cognitive remediation has two components: computer-based cognitive exercise sessions held on a twice weekly basis for 10 weeks as well as 10 weekly group discussion sessions (approximately 60 minutes in duration). |
| Supported Education Only | Active comparator | Behavioral: Supported EducationThe George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness (see http://www.georgebrown.ca/marketing/FTCal/access/C702.aspx for a full description). Participants in this arm will receive all services and supports provided by this program. However, they will not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- a psychiatric history of mental retardation, brain injury, or other neurological condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RemediationAlso: CRTThe 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. | Behavioural | Cognitive Remediation and Supported Education |
| Supported EducationAlso: SE, RTE, Redirection Through EducationStudents 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. | Behavioural | Supported Education Only |
Primary outcome
Completion of Academic Semesters
Time frame: 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.
18 secondary outcomes
Positive and Negative Symptoms Scale (PANSS) Score at 3 Months
Time frame: 3 months following baseline
The Rosenberg Self-Esteem Scale Score at 3 Months
Time frame: 3 months following Baseline
The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months
Time frame: 6 months following Baseline assessment
The Rosenberg Self-Esteem Scale Score at 6 Months
Time frame: 6 months following Baseline assessment
The California Verbal Learning Test at 3 Months
Time frame: 3 months following Baseline Assessment
The California Verbal Learning Test at 6 Months
Time frame: 6 months following Baseline assessment
The Trail Making Test Part A at 3 Months
Time frame: 3 months following Baseline assessment
The Trail Making Test Part A at 6 Months
Time frame: 6 months following Baseline assessment
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months
Time frame: 3 months following Baseline assessment
The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months
Time frame: 6 months following Baseline assessment
The Trail Making Test Part B at 3 Months
Time frame: 3 months following Baseline assessment
The Trail Making Part B at 6 Months
Time frame: 6 months following Baseline assessment
The Wisconsin Card Sorting Test at 3 Months
Time frame: 3 months following Baseline assessment
The Wisconsin Card Sorting Test at 3 Months
Time frame: 3 months following Baseline assessment
The Wisconsin Card Sorting Task at 6 Months
Time frame: 6 months following Baseline assessment
The Wisconsin Card Sorting Task at 6 Months
Time frame: 6 months following baseline assessment
The Digit Vigilance Test at 3 Months
Time frame: 3 months following Baseline assessment
The Digit Vigilance Test at 6 Months
Time frame: 6 months following baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18840561Anthony WA. Cognitive remediation and psychiatric rehabilitation. Psychiatr Rehabil J. 2008 Fall;32(2):87-8. doi: 10.2975/32.2.2008.87.88. No abstract available.
- Background: PubMed 11483142Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
- Background: PubMed 18889466BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. doi: 10.1080/00221309.1948.9918159. No abstract available.
- BackgroundDavidson, L. (2003). Living Outside Mental Illness: Qualitative Studies of Recovery in Schizophrenia. New York City, NY: New York University Press.
- BackgroundDelis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.
- Background: PubMed 16368053Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.
- Background: PubMed 15531406Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.
- BackgroundHealth Canada. (2002). A Report on Mental Illnesses in Canada. Ottawa: Health Canada.
- Background: PubMed 18718884Hodge MA, Siciliano D, Withey P, Moss B, Moore G, Judd G, Shores EA, Harris A. A randomized controlled trial of cognitive remediation in schizophrenia. Schizophr Bull. 2010 Mar;36(2):419-27. doi: 10.1093/schbul/sbn102. Epub 2008 Aug 20.
- Background: PubMed 3616518Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
- Background: PubMed 14588938Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44.
- Background: PubMed 19006657Kurtz MM, Seltzer JC, Fujimoto M, Shagan DS, Wexler BE. Predictors of change in life skills in schizophrenia after cognitive remediation. Schizophr Res. 2009 Feb;107(2-3):267-74. doi: 10.1016/j.schres.2008.10.014. Epub 2008 Nov 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean A. Kidd, Ph.D. principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation and Supported Education in people with Psychosis, run by Centre for Addiction and Mental Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Academic Semesters (time frame: The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492439, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.