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临床试验/NCT01492439
NCT01492439已完成不适用

Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting

Centre for Addiction and Mental Health4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
4
主要终点
Completion of Academic Semesters

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • a psychiatric history of mental retardation, brain injury, or other neurological condition.

结局指标

主要结局

Completion of Academic Semesters

时间窗: 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.

次要结局

  • 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 Test at 3 Months(3 months following Baseline assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Kidd

Principal Investigator, Independent Clinician Scientist and Head of Psychology Services

Centre for Addiction and Mental Health

研究点 (4)

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