Clinical trial NCT01492439: Effectiveness of Cognitive Remediation in a Supported Education Setting
Official title: Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Psychosis
Psychosis NOS
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: George Brown College
First posted: 2011-12-15
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Completion of Academic Semesters
timeFrame: The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)
Secondary outcomes:
measure: Positive and Negative Symptoms Scale (PANSS) Score at 3 Months
timeFrame: 3 months following baseline
measure: The Rosenberg Self-Esteem Scale Score at 3 Months
timeFrame: 3 months following Baseline
measure: The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The Rosenberg Self-Esteem Scale Score at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The California Verbal Learning Test at 3 Months
timeFrame: 3 months following Baseline Assessment
measure: The California Verbal Learning Test at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The Trail Making Test Part A at 3 Months
timeFrame: 3 months following Baseline assessment
measure: The Trail Making Test Part A at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months
timeFrame: 3 months following Baseline assessment
measure: The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The Trail Making Test Part B at 3 Months
timeFrame: 3 months following Baseline assessment
measure: The Trail Making Part B at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The Wisconsin Card Sorting Test at 3 Months
timeFrame: 3 months following Baseline assessment
measure: The Wisconsin Card Sorting Test at 3 Months
timeFrame: 3 months following Baseline assessment
measure: The Wisconsin Card Sorting Task at 6 Months
timeFrame: 6 months following Baseline assessment
measure: The Wisconsin Card Sorting Task at 6 Months
timeFrame: 6 months following baseline assessment
measure: The Digit Vigilance Test at 3 Months
timeFrame: 3 months following Baseline assessment
measure: The Digit Vigilance Test at 6 Months
timeFrame: 6 months following baseline assessment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: George Brown College
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Sean A. Kidd, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bell 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.
citation: BERG 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.
citation: Davidson, L. (2003). Living Outside Mental Illness: Qualitative Studies of Recovery in Schizophrenia. New York City, NY: New York University Press.
citation: Delis, D., Kramer, J., Kaplan. E., & Ober, B. (1987). California Verbal Learning and Memory Test (Manual). San Antonio, TX: Psychological Corporation.
citation: 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.
citation: Green 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.
citation: Health Canada. (2002). A Report on Mental Illnesses in Canada. Ottawa: Health Canada.
citation: 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.
citation: Kay 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.
citation: Kelland DZ, Lewis RF. The Digit Vigilance Test: reliability, validity, and sensitivity to diazepam. Arch Clin Neuropsychol. 1996;11(4):339-44.
citation: Kurtz 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.
citation: Kurtz 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.
citation: McGrew 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.
citation: Lezak, M. D. (1995). Neuropsychological Assessment. New York: Oxford University.
citation: Lindenmayer JP, McGurk SR, Mueser KT, Khan A, Wance D, Hoffman L, Wolfe R, Xie H. A randomized controlled trial of cognitive remediation among inpatients with persistent mental illness. Psychiatr Serv. 2008 Mar;59(3):241-7. doi: 10.1176/ps.2008.59.3.241.
citation: McGurk SR, Mueser KT. Cognitive functioning, symptoms, and work in supported employment: a review and heuristic model. Schizophr Res. 2004 Oct 1;70(2-3):147-73. doi: 10.1016/j.schres.2004.01.009.
citation: McGurk SR, Mueser KT, DeRosa TJ, Wolfe R. Work, recovery, and comorbidity in schizophrenia: a randomized controlled trial of cognitive remediation. Schizophr Bull. 2009 Mar;35(2):319-35. doi: 10.1093/schbul/sbn182. Epub 2009 Mar 5.
citation: McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
citation: Medalia A, Richardson R. What predicts a good response to cognitive remediation interventions? Schizophr Bull. 2005 Oct;31(4):942-53. doi: 10.1093/schbul/sbi045. Epub 2005 Aug 24.
citation: Mowbray CT, Bybee D, Collins ME. Follow-up client satisfaction in a supported education program. Psychiatr Rehabil J. 2001 Winter;24(3):237-47. doi: 10.1037/h0095088.
citation: Radford LM, Chaney EF, O'Leary MR, O'Leary DE. Screening for cognitive impairment among inpatients. J Clin Psychiatry. 1978 Sep;39(9):712-5.
citation: Reeder C, Smedley N, Butt K, Bogner D, Wykes T. Cognitive predictors of social functioning improvements following cognitive remediation for schizophrenia. Schizophr Bull. 2006 Oct;32 Suppl 1(Suppl 1):S123-31. doi: 10.1093/schbul/sbl019. Epub 2006 Aug 10.
citation: Rosenberg, M., (1965). Society and the Adolescent Self Image. Princeton, NJ: Princeton University Press.
citation: Reichenberg A, Harvey PD. Neuropsychological impairments in schizophrenia: Integration of performance-based and brain imaging findings. Psychol Bull. 2007 Sep;133(5):833-58. doi: 10.1037/0033-2909.133.5.833.
citation: Rose, D., & Wykes, T., Farrier, D., Doran, A., Sporle, T., & Bogner, D. (2008). What do clients think of cognitive remediation therapy?: A consumer led investigation of satisfaction and side effects. American Journal of Psychiatric Rehabilitation, 11, 181-204.
citation: The Psychological Corporation. (1997). WAIS-III administration and scoring manual. San Antonio, TX: Psychological Corporation.
citation: Vauth R, Corrigan PW, Clauss M, Dietl M, Dreher-Rudolph M, Stieglitz RD, Vater R. Cognitive strategies versus self-management skills as adjunct to vocational rehabilitation. Schizophr Bull. 2005 Jan;31(1):55-66. doi: 10.1093/schbul/sbi013. Epub 2005 Feb 16.
citation: Wilkinson ,G. (1993). Wide Range Achievement Test 3 (Manual). Wilmington, DE: Wide Range Inc.
citation: Wykes T, Huddy V. Cognitive remediation for schizophrenia: it is even more complicated. Curr Opin Psychiatry. 2009 Mar;22(2):161-7. doi: 10.1097/YCO.0b013e328322fbf4.
citation: Wykes T, Reeder C, Williams C, Corner J, Rice C, Everitt B. Are the effects of cognitive remediation therapy (CRT) durable? Results from an exploratory trial in schizophrenia. Schizophr Res. 2003 Jun 1;61(2-3):163-74. doi: 10.1016/s0920-9964(02)00239-6.