Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01683539 · ClinicalTrials.gov registry record · NA
Understanding How Cognitive Remediation Works
A NA study, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- NA
- Development phase
- 203
- Enrollment target
NCT01683539 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 203 participants.
The verdict
NCT01683539, a NA study, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- NA
- Development phase
- 203 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL The Thinking Skills for Work Program
- BEHAVIORAL The Cognitive Skills for Work Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2012-09 |
| Est. Completion | 2019-03-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01683539
The ClinicalTrials.gov registry entry for NCT01683539 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which The Thinking Skills for Work Program is the first listed.
NCT01683539 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01683539 about?
NCT01683539 is a clinical study titled "Understanding How Cognitive Remediation Works". 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 s...
What is the current status of trial NCT01683539?
This trial is currently completed. It is a NA study. The enrollment target is 203 participants. The study started on 2012-09. Estimated completion is 2019-03-11.
What interventions are being tested in trial NCT01683539?
The interventions under investigation include: The Thinking Skills for Work Program (BEHAVIORAL), The Cognitive Skills for Work Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01683539?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.