Improving Work Outcomes for Veterans With Traumatic Brain Injury
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 12, 2015
February 1, 2015
3.9 years
June 20, 2008
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weeks worked
12 months
Secondary Outcomes (5)
Hours worked
12 months
Dollars earned from working
12 months
Cognitive performance
3, 6, and 12 months
Neurobehavioral symptoms
3, 6, and 12 months
Quality of life
3, 6, and 12 months
Study Arms (2)
1
EXPERIMENTALSupported employment for 12 months plus cognitive training for the first 12 weeks
2
ACTIVE COMPARATORSupported employment for 12 months plus one additional supported employment session per week for the first 12 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current alcohol/substance abuse or dependence
- Participation in other intervention studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System
San Diego, California, 92161, United States
Related Publications (1)
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.
PMID: 26147236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth W Twamley, PhD
University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 24, 2008
Study Start
September 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
February 12, 2015
Record last verified: 2015-02