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Improving Work Outcomes for Veterans With Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Department of Defense.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Department of Defense
ClinicalTrials.gov Identifier:
NCT00704067
First received: June 20, 2008
Last updated: February 24, 2010
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Traumatic Brain Injury
 Behavioral: Supported employment plus cognitive training
Behavioral: Enhanced supported employment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Work Outcomes for Veterans With Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Defense:

Primary Outcome Measures:
  • Weeks worked [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hours worked [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Dollars earned from working [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cognitive performance [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Neurobehavioral symptoms [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: September 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704067

Contacts
Contact: Elizabeth W Twamley, PhD 619-497-6684 etwamley@ucsd.edu

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Principal Investigator: Elizabeth W Twamley, PhD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Elizabeth W. Twamley, PhD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00704067     History of Changes
Other Study ID Numbers: PT075291
Study First Received: June 20, 2008
Last Updated: February 24, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Defense:
vocational rehabilitation
supported employment
cognitive training
 cognitive remediation
cognitive rehabilitation
veterans

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

ClinicalTrials.gov processed this record on May 23, 2013