Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Completion of Academic Semesters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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).
Intervention: Cognitive Remediation (Behavioral)
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.
Intervention: Supported Education (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The Wisconsin Card Sorting Test at 3 Months(3 months following Baseline assessment)
- Positive and Negative Symptoms Scale (PANSS) Score at 3 Months(3 months following baseline)
- The Rosenberg Self-Esteem Scale Score at 3 Months(3 months following Baseline)
- The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months(6 months following Baseline assessment)
- The Rosenberg Self-Esteem Scale Score at 6 Months(6 months following Baseline assessment)
- The California Verbal Learning Test at 3 Months(3 months following Baseline Assessment)
- The California Verbal Learning Test at 6 Months(6 months following Baseline assessment)
- The Trail Making Test Part A at 3 Months(3 months following Baseline assessment)
- The Trail Making Test Part A at 6 Months(6 months following Baseline assessment)
- The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months(3 months following Baseline assessment)
- The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months(6 months following Baseline assessment)
- The Trail Making Test Part B at 3 Months(3 months following Baseline assessment)
- The Trail Making Part B at 6 Months(6 months following Baseline assessment)
- The Wisconsin Card Sorting Task at 6 Months(6 months following baseline assessment)
- The Digit Vigilance Test at 3 Months(3 months following Baseline assessment)
- The Digit Vigilance Test at 6 Months(6 months following baseline assessment)
- The Wisconsin Card Sorting Task at 6 Months(6 months following Baseline assessment)
Investigators
Sean Kidd
Principal Investigator, Independent Clinician Scientist and Head of Psychology Services
Centre for Addiction and Mental Health
