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Understanding How Cognitive Remediation Works (Cog-2)

This study is currently recruiting participants.
Verified June 2013 by Boston University
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01683539
First received: August 17, 2012
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  Purpose

This study is aimed at evaluating whether the computer-based cognitive exercises in the Thinking Skills for Work (TSW) program are critical to improving work and cognitive outcomes in consumers with serious mental illness and cognitive impairment enrolled in supported employment (SE), or whether a streamlined version of TSW without this component (the Cognitive Skills for Work (CSW) program) is equally effective for some or all consumers. An RCT will be conducted at two sites (Mental Health Center of Greater Manchester in New Hampshire and Thresholds Inc. in Illinois) with 244 consumers randomly assigned to one of two groups (122 each, with approximately 122 participants having schizophrenia or schizoaffective disorder and 122 of the participants having other diagnoses): 1) TSW, or 2) CSW. The TSW and CSW programs will be delivered by the same Cognitive Specialists, who will work as members of the SE team to integrate cognitive and vocational services. All participants will continue to receive SE services. Participants will be assessed at baseline, post-treatment at 8 months (after completion of the active teaching components of TSW or CSW), and at 16 and 24 months post-baseline to evaluate cognitive functioning, symptoms, and quality of life. All work outcomes will be tracked weekly.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Chronic Mental Disorder
Major Depression
Bipolar Disorder
 Behavioral: The Thinking Skills for Work Program
Behavioral: The Cognitive Skills for Work Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dismantling Study of Cognitive Remediation for Supported Employment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • AMOUNT OF EMPLOYMENT [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
    TOTAL HOURS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.


Secondary Outcome Measures:
  • EXECUTIVE FUNCTIONING AND MEMORY [ Time Frame: BASELINE, 8, 16, and 24 months. ] [ Designated as safety issue: No ]

    CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 8 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.

    CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 16 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY..

    CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 24 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY..



Estimated Enrollment: 244
Study Start Date: September 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The Thinking Skills for Work Program
The Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation.
 Behavioral: The Thinking Skills for Work Program
The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and work services.
Active Comparator: The Cognitive Skills for Work Program
The Cognitive Skills for Work Program includes 4 components delivered by a Cognitive Specialist who works with the consumer's Employment Specialist: a) assessing the consumer's cognitive strengths and weaknesses their relation to job history b) teaching coping strategies for cognitive challenges associated with job search or maintenance c)job search planning, in which the consumer and the Cognitive and Employment Specialists help identify job leads based on the consumer's interests, and identify cognitive coping strategies and supports the consumer may need to succeed at the workplace; and d) job support consultation, in which the Cognitive and Employment Specialists consult with the consumer on additional cognitive coping strategies to enable the consumer to meet the demands of the job.
 Behavioral: The Cognitive Skills for Work Program
The Cognitive Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, compensatory strategy training, and integration of cognitive and work services.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic mental disorder
  • Minimum age 18.
  • Unemployed
  • Wants employment
  • Fluent in English.
  • Cognitively impaired, as defined by 1.0 SD below normative scores in memory or executive functioning
  • Willing and legally able to provide informed consent to participate in study. Subjects with court appointed legal guardians will be included.

Exclusion Criteria:

-History of neurological conditions that impair cognition

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683539

Locations
United States, Illinois
Thresholds Recruiting
Chicago, Illinois, United States, 60613
Contact: Susan M Kaiser, M.P.H.     773-572-5320     skaiser@tdart.org    
United States, New Hampshire
The Mental Health Center of Greater Manchester Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Susan Guarino, RNC     603-668-4111     guarinos@mhcgm.org    
Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan McGurk, Ph.D. Center for Psychiatric Rehabilitation, Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01683539     History of Changes
Other Study ID Numbers: 2837E, 2R01MH077210-05A1
Study First Received: August 17, 2012
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Boston University:
Schizophrenia
Chronic Mental Disorder
Employment
Cognitive remediation
Vocational rehabilitation

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Bipolar Disorder
Depression
Depressive Disorder
Schizophrenia
 Depressive Disorder, Major
Schizophrenia and Disorders with Psychotic Features
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 17, 2013