Effectiveness of Cognitive Remediation in a Supported Education Setting
NCT ID: NCT01492439
Last Updated: 2014-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Remediation and Supported Education
Participants in this group will receive cognitive remediation training in addition to supported education. Cognitive remediation has two components: computer-based cognitive exercise sessions held on a twice weekly basis for 10 weeks as well as 10 weekly group discussion sessions (approximately 60 minutes in duration).
Cognitive Remediation
The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness. In addition to the supports available to all RTE students, this group will receive a total of twenty 45 minute computer-based cognitive exercise sessions held twice a week using COGPACK (Ver 6.0,www.cogpack.de). This program facilitates practice across a range of cognitive functions, including attention,psychomotor speed,memory, and executive functions. Participants will also take part in 10 weekly group discussion sessions,approximately 60 minutes in duration, focusing on strategies for management of symptoms and other cognitive deficits in an academic setting.
Supported Education Only
The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness (see http://www.georgebrown.ca/marketing/FTCal/access/C702.aspx for a full description). Participants in this arm will receive all services and supports provided by this program. However, they will not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
Supported Education
Students enroll in credit courses, such as communications, computer skills, and the psychology of human relations which can lead to eligibility for post-secondary programs. Remedial skills in English, supervised study skills classes and other non-credit courses are included. Vocational testing is offered to help students determine their interests and aptitudes and students try out possible careers as well as their readiness to return to work by engaging in volunteer and work placements. Counsellors are also available to assist students in areas such as learning difficulties and coping with the stresses of school. The overarching goal of this program is to help students explore valued non-illness identities, build confidence, and re-engage with their communities.
Interventions
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Cognitive Remediation
The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness. In addition to the supports available to all RTE students, this group will receive a total of twenty 45 minute computer-based cognitive exercise sessions held twice a week using COGPACK (Ver 6.0,www.cogpack.de). This program facilitates practice across a range of cognitive functions, including attention,psychomotor speed,memory, and executive functions. Participants will also take part in 10 weekly group discussion sessions,approximately 60 minutes in duration, focusing on strategies for management of symptoms and other cognitive deficits in an academic setting.
Supported Education
Students enroll in credit courses, such as communications, computer skills, and the psychology of human relations which can lead to eligibility for post-secondary programs. Remedial skills in English, supervised study skills classes and other non-credit courses are included. Vocational testing is offered to help students determine their interests and aptitudes and students try out possible careers as well as their readiness to return to work by engaging in volunteer and work placements. Counsellors are also available to assist students in areas such as learning difficulties and coping with the stresses of school. The overarching goal of this program is to help students explore valued non-illness identities, build confidence, and re-engage with their communities.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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George Brown College
OTHER
Centre for Addiction and Mental Health
OTHER
Responsible Party
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Sean Kidd
Principal Investigator, Independent Clinician Scientist and Head of Psychology Services
Principal Investigators
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Sean A. Kidd, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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George Brown College
Toronto, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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References
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Other Identifiers
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143/2011
Identifier Type: -
Identifier Source: org_study_id
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