Understanding How Cognitive Remediation Works (Cog-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01683539
First received: August 17, 2012
Last updated: July 29, 2014
Last verified: July 2014

August 17, 2012
July 29, 2014
September 2012
January 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01683539 on ClinicalTrials.gov Archive Site
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..

EXECUTIVE FUNCTIONING AND MEMORY [ Time Frame: BASELINE, 6, 12, and 24 months. ] [ Designated as safety issue: No ]

CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 6 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.

CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 12 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY..

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

Not Provided
Not Provided
 
Understanding How Cognitive Remediation Works
A Dismantling Study of Cognitive Remediation for Supported Employment

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.

Unemployment is a major burden for people with severe mental illness (SMI) such as schizophrenia, with competitive work rates typically between 10-20%. Over the past two decades, supported employment (SE) has been shown to improve competitive work in persons with SMI, and it is now considered an evidence-based practice (EBP). However, there is a need to improve the effectiveness of SE, as 30-60% of consumers work little or not at all, and jobs are often brief and end unsuccessfully. Cognitive remediation, when combined with vocational rehabilitation, has shown promise for improving work outcomes, including in consumers in SE. The most extensively studied approach is the Thinking Skills for Work (TSW) program, developed by this research group, which incorporates computer-based cognitive exercises to restore cognitive skills and teaching compensatory strategies by a Cognitive Specialist who is integrated into the vocational rehabilitation team. Five randomized controlled trials (RCTs), two conducted in SE programs (including one previously conducted by this research group), have shown that adding the TSW program to vocational (SE) services improves work and cognitive outcomes compared to vocational (SE) services alone.

The proposed study takes the next bold step of "dismantling" the TSW program to evaluate whether the cognitive practice exercises component is critical to improving outcomes in SE, or whether a more streamlined and efficient version of the program that focuses only on teaching compensatory skills is sufficient. The study will also yield important information about whether some consumers benefit from computer cognitive exercises, but not others, permitting the TSW program to be individually tailored to consumers' personal needs.

In preparation for the proposed study we developed, standardized, and pilot tested a variant of the TSW program, the Cognitive Skills for Work (CSW) program, that teaches compensatory skills for managing cognitive difficulties but omits computer cognitive exercises, resulting in a program that is approximately one-half the intensity of the original TSW program. A small ongoing pilot study indicated that consumers in SE could be readily engaged and retained in the CSW program and obtain work, supporting the feasibility of this streamlined version of TSW. The proposed research will be an RCT conducted at two high fidelity SE programs, comparing the effects of the TSW and CSW programs in consumers enrolled in SE.

The following hypotheses will be tested:

  1. Primary Hypothesis: Participants in TSW will have better competitive work outcomes than those in the CSW program. This hypothesis is based on the fact that virtually all cognitive remediation research on SMI has included cognitive exercises designed to restore cognitive skills, such as the computer-based cognitive exercises in TSW, with some programs also teaching compensatory strategies. If the null hypothesis is not rejected, and TSW is found to be not significantly more effective than CSW, then dissemination efforts can focus on the more efficient CSW.
  2. Secondary Hypothesis: Participants in TSW will improve more in cognitive functioning than those in CSW. This hypothesis is based on the same rationale as Hypothesis #1.

Exploratory Analyses In addition to evaluating whether the TSW and CSW programs differ overall in their impact on vocational and cognitive outcomes, we will explore whether consumer characteristics can be identified that predict a differential response to either program. For example, it is possible that consumers with more severe cognitive impairment will respond better to the full TSW program, whereas those with less severe impairment may benefit equally well from the more efficient CSW program.

The proposed research has high potential impact for improving the outcomes of SE, an established EBP for increasing competitive work in SMI, but whose effectiveness is limited by the extent of consumers' cognitive impairment. Maximizing the efficiency of the TSW program, a cognitive remediation program shown to improve work outcomes in two RCTs of SE programs, by determining whether a more streamlined version of the program that requires about one-half the time to implement (the CSW program) is equally effective, could reduce the costs of disseminating and implementing the program, making it accessible to more consumers. This study could also help identify which consumers benefit most from the cognitive exercises component of TSW, thereby facilitating tailoring of the program to the individual's personal needs. Ultimately, this research could play a critical role in making the dream of competitive work a reality for many consumers with SMI.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Chronic Mental Disorder
  • Major Depression
  • Bipolar Disorder
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: The Thinking Skills for Work Program
  • 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.
    Intervention: Behavioral: The Cognitive Skills for Work Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
244
January 2017
January 2017   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
United States
 
NCT01683539
2837E, 2R01MH077210-05A1
Yes
Boston University
Boston University
National Institute of Mental Health (NIMH)
Principal Investigator: Susan McGurk, Ph.D. Center for Psychiatric Rehabilitation, Boston University
Boston University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP