Effectiveness of Cognitive Remediation in a Supported Education Setting

NCT01492439 | Completed Results

• 1 other identifier: 143/2011
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychosis

Keywords

Psychosis; Psychosis NOS; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Completion of Academic Semesters

  During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2.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.

  The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)

Secondary Outcomes (18)

• 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

Study Arms (2)

Cognitive Remediation and Supported Education

EXPERIMENTAL

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).

Behavioral: Cognitive Remediation

Supported Education Only

ACTIVE COMPARATOR

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.

Behavioral: Supported Education

Interventions

Cognitive Remediation BEHAVIORAL

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.

Also known as: CRT

Cognitive Remediation and Supported Education

Supported Education BEHAVIORAL

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.

Also known as: SE, RTE, Redirection Through Education

Supported Education Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• George Brown College: collaborator

Study Sites (2)

George Brown College

Toronto, Ontario, M5T 2T9, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H1, Canada

Location

Related Publications (31)

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MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Schizophrenia; Bipolar Disorder

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Sean A. Kidd
• Organization: Centre for Addiction and Mental Health

sean.kidd@camh.ca

416-535-8501

Study Officials

• Sean A. Kidd, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Independent Clinician Scientist and Head of Psychology Services

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 11, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-06

Locations

CA (2)