Understanding How Cognitive Remediation Works
Cog-2
A Dismantling Study of Cognitive Remediation for Supported Employment
2 other identifiers
interventional
203
1 country
2
Brief Summary
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. In addition, a supplementary study, commencing in September 2015, will assess a promising biomarker for understanding the mechanisms underlying the effects of cognitive remediation, brain-derived neurotrophic factor (BDNF), in new enrollees in the parent R01 study. This supplement will complement the aims of the parent R01 by shedding light on possible mechanisms related to how TSW works and for whom, thereby informing efforts to refine and improve the program, as well as targeting individuals who fail to benefit. The supplement will take place at the same sites as the parent R01.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Sep 2012
Longer than P75 for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2019
CompletedMarch 13, 2019
March 1, 2019
6.5 years
August 17, 2012
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AMOUNT OF EMPLOYMENT
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.
24 MONTHS
Secondary Outcomes (1)
EXECUTIVE FUNCTIONING AND MEMORY
BASELINE, 8, 16, and 24 months.
Other Outcomes (1)
BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF) - AS PART OF SUPPLEMENTAL SUB-STUDY
BASELINE, 8, 16, and 24 months.
Study Arms (2)
The Thinking Skills for Work Program
EXPERIMENTALThe 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.
The Cognitive Skills for Work Program
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of neurological conditions that impair cognition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Thresholds
Chicago, Illinois, 60613, United States
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan McGurk, Ph.D.
Center for Psychiatric Rehabilitation, Boston University
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
- Associate Professor
Study Record Dates
First Submitted
August 17, 2012
First Posted
September 12, 2012
Study Start
September 1, 2012
Primary Completion
March 11, 2019
Study Completion
March 11, 2019
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share