Schizophrenia Clinical Trial
— Cog-2Official title:
A Dismantling Study of Cognitive Remediation for Supported Employment
Verified date | March 2019 |
Source | Boston University Charles River Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 203 |
Est. completion date | March 11, 2019 |
Est. primary completion date | March 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thresholds | Chicago | Illinois |
United States | The Mental Health Center of Greater Manchester | Manchester | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF) - AS PART OF SUPPLEMENTAL SUB-STUDY | CHANGE FROM BASELINE IN LEVELS OF BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF) AT 8 MONTHS USING ABCAM'S BDNF HUMAN ELISA (ENZYME-LINKED IMMUNOSORBENT ASSAY) KIT. CHANGE FROM BASELINE IN LEVELS OF BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF) AT 16 MONTHS USING ABCAM'S BDNF HUMAN ELISA (ENZYME-LINKED IMMUNOSORBENT ASSAY) KIT. CHANGE FROM BASELINE IN LEVELS OF BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF) AT 24 MONTHS USING ABCAM'S BDNF HUMAN ELISA (ENZYME-LINKED IMMUNOSORBENT ASSAY) KIT. |
BASELINE, 8, 16, and 24 months. | |
Primary | 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 | EXECUTIVE FUNCTIONING AND MEMORY | 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. |
BASELINE, 8, 16, and 24 months. |
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