Improving Work Outcomes for Veterans With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Improving Work Outcomes for Veterans With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704067
• Other study ID #: PT075291
• Status: Completed
• Phase: N/A
• First received: June 20, 2008
• Last updated: February 11, 2015
• Start date: September 2008
• Est. completion date: August 2012

Study information

• Verified date: February 2015
• Source: United States Department of Defense
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Behavioral:
• Supported employment plus cognitive training
Supported employment for 12 months plus cognitive training for the first 12 weeks
• Enhanced supported employment
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weeks worked		12 months	No
Secondary	Hours worked		12 months	No
Secondary	Dollars earned from working		12 months	No
Secondary	Cognitive performance		3, 6, and 12 months	No
Secondary	Neurobehavioral symptoms		3, 6, and 12 months	No
Secondary	Quality of life		3, 6, and 12 months	No