Back to resultsImproving Work Outcomes for Veterans With Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supported employment plus cognitive training
Enhanced supported employment
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring vocational rehabilitation, supported employment, cognitive training, cognitive remediation, cognitive rehabilitation, veterans
Eligibility Criteria
Inclusion Criteria:
- OEF/OIF veteran
- History of mild-to-moderate TBI (loss of consciousness <6 hours; post-traumatic amnesia <7 days)
- Documented impairment in at least one neuropsychological domain
- Unemployed, but stating a goal of work
- Written informed consent to participate in the study
Exclusion Criteria:
- Current alcohol/substance abuse or dependence
- Participation in other intervention studies
Sites / Locations
- VA San Diego Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Supported employment for 12 months plus cognitive training for the first 12 weeks
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks
Outcomes
Primary Outcome Measures
Weeks worked
Secondary Outcome Measures
Hours worked
Dollars earned from working
Cognitive performance
Neurobehavioral symptoms
Quality of life
Full Information
NCT ID
NCT00704067
First Posted
June 20, 2008
Last Updated
February 11, 2015
Sponsor
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT00704067
Brief Title
Improving Work Outcomes for Veterans With Traumatic Brain Injury
Official Title
Improving Work Outcomes for Veterans With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Department of Defense
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The 12-month study will investigate a cognitive training augmentation of supported employment to improve cognitive performance and work outcomes, which are expected to result in improved quality of life and community integration for veterans with mild to moderate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who receive supported employment plus cognitive training will work more weeks during the 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
vocational rehabilitation, supported employment, cognitive training, cognitive remediation, cognitive rehabilitation, veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Supported employment for 12 months plus cognitive training for the first 12 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Supported employment plus cognitive training
Intervention Description
Supported employment for 12 months plus cognitive training for the first 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Enhanced supported employment
Intervention Description
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.
Primary Outcome Measure Information:
Title
Weeks worked
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hours worked
Time Frame
12 months
Title
Dollars earned from working
Time Frame
12 months
Title
Cognitive performance
Time Frame
3, 6, and 12 months
Title
Neurobehavioral symptoms
Time Frame
3, 6, and 12 months
Title
Quality of life
Time Frame
3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OEF/OIF veteran
History of mild-to-moderate TBI (loss of consciousness <6 hours; post-traumatic amnesia <7 days)
Documented impairment in at least one neuropsychological domain
Unemployed, but stating a goal of work
Written informed consent to participate in the study
Exclusion Criteria:
Current alcohol/substance abuse or dependence
Participation in other intervention studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth W Twamley, PhD
Organizational Affiliation
University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26147236
Citation
Walter KH, Jak AJ, Twamley EW. Psychiatric comorbidity effects on compensatory cognitive training outcomes for veterans with traumatic brain injuries. Rehabil Psychol. 2015 Aug;60(3):303-8. doi: 10.1037/rep0000049. Epub 2015 Jul 6.
Results Reference
derived
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Improving Work Outcomes for Veterans With Traumatic Brain Injury
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