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Clinical Trials/NCT01683539
NCT01683539CompletedNot Applicable

A Dismantling Study of Cognitive Remediation for Supported Employment

Boston University Charles River Campus2 sites in 1 country203 target enrollmentStarted: September 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
203
Locations
2
Primary Endpoint
AMOUNT OF EMPLOYMENT

Study Overview

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.

Detailed Description

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:

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Chronic mental disorder
  • •Minimum age
  • •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

Arms & Interventions

The Thinking Skills for Work Program

Experimental

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: The Thinking Skills for Work Program (Behavioral)

The Cognitive Skills for Work Program

Active Comparator

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: The Cognitive Skills for Work Program (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • EXECUTIVE FUNCTIONING AND MEMORY(BASELINE, 8, 16, and 24 months.)

Investigators

Sponsor
Boston University Charles River Campus
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Susan Mcgurk

Associate Professor

Boston University

Study Sites (2)

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