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Understanding How Cognitive Remediation Works (Cog-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Mcgurk, Boston University
ClinicalTrials.gov Identifier:
NCT01683539
First received: August 17, 2012
Last updated: August 9, 2017
Last verified: August 2017
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dismantling Study of Cognitive Remediation for Supported Employment

Resource links provided by NLM:


Further study details as provided by Susan Mcgurk, Boston University:

Primary Outcome Measures:
  • AMOUNT OF EMPLOYMENT [ Time Frame: 24 MONTHS ]
    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. ]

    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
Actual Study Start Date: September 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic mental disorder
  • Minimum age 18.
  • Unemployed
  • Wants employment
  • Must be a recipient of services at one of two participating agencies
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Thresholds
Chicago, Illinois, United States, 60613
United States, New Hampshire
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States, 03103
Sponsors and Collaborators
Boston University Charles River Campus
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan McGurk, Ph.D. Center for Psychiatric Rehabilitation, Boston University
  More Information

Responsible Party: Susan Mcgurk, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT01683539     History of Changes
Other Study ID Numbers: 2837E
2R01MH077210-05A1 ( U.S. NIH Grant/Contract )
Study First Received: August 17, 2012
Last Updated: August 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Depressive Disorder, Major
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders

ClinicalTrials.gov processed this record on September 19, 2017