Understanding How Cognitive Remediation Works
Completed · Not applicable
Conditions studied: Schizophrenia, Schizoaffective Disorder, Chronic Mental Disorder, Major Depression, Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT01683539
- Run by
- Boston University Charles River Campus
- People needed
- 203
- Starts
- 2012-09-01
- Expected to finish
- 2019-03-11
- Last updated by the study team
- 2019-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Thresholds — Chicago, Illinois, United States
- The Mental Health Center of Greater Manchester — Manchester, New Hampshire, United States
Full record on ClinicalTrials.gov
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