Effectiveness of Cognitive Remediation in a Supported Education Setting

Psychosis Clinical Trial

Official title: Examining the Effectiveness of Cognitive Remediation in a Supported Education Setting

Status Completed

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychosis

• NCT number: NCT01492439
• Study type: Interventional
• Source: Centre for Addiction and Mental Health
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Completion date: July 2013