Improving Work Outcomes for Veterans With Traumatic Brain Injury

February 11, 2015 updated by: Elizabeth W. Twamley, PhD, United States Department of Defense
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weeks worked
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hours worked
Time Frame: 12 months
12 months
Dollars earned from working
Time Frame: 12 months
12 months
Cognitive performance
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
Neurobehavioral symptoms
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
Quality of life
Time Frame: 3, 6, and 12 months
3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (ESTIMATE)

June 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT075291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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