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Improving Work Outcomes for Veterans With Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00704067
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Elizabeth W. Twamley, PhD, Department of Defense

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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Behavioral: Supported employment plus cognitive training Behavioral: Enhanced supported employment

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Work Outcomes for Veterans With Traumatic Brain Injury
Study Start Date : September 2008
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Supported employment for 12 months plus cognitive training for the first 12 weeks
Behavioral: Supported employment plus cognitive training
Supported employment for 12 months plus cognitive training for the first 12 weeks
Active Comparator: 2
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks
Behavioral: Enhanced supported employment
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.



Primary Outcome Measures :
  1. Weeks worked [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hours worked [ Time Frame: 12 months ]
  2. Dollars earned from working [ Time Frame: 12 months ]
  3. Cognitive performance [ Time Frame: 3, 6, and 12 months ]
  4. Neurobehavioral symptoms [ Time Frame: 3, 6, and 12 months ]
  5. Quality of life [ Time Frame: 3, 6, and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704067


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
United States Department of Defense
Investigators
Principal Investigator: Elizabeth W Twamley, PhD University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth W. Twamley, PhD, Principal Investigator, Department of Defense
ClinicalTrials.gov Identifier: NCT00704067     History of Changes
Other Study ID Numbers: PT075291
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Elizabeth W. Twamley, PhD, Department of Defense:
vocational rehabilitation
supported employment
cognitive training
cognitive remediation
cognitive rehabilitation
veterans

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System