Improving Work Outcomes for Veterans With Traumatic Brain Injury

NCT ID: NCT00704067

Last Updated: 2015-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Supported employment for 12 months plus cognitive training for the first 12 weeks

Group Type EXPERIMENTAL

Supported employment plus cognitive training

Intervention Type BEHAVIORAL

Supported employment for 12 months plus cognitive training for the first 12 weeks

2

Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks

Group Type ACTIVE_COMPARATOR

Enhanced supported employment

Intervention Type BEHAVIORAL

Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.

Interventions

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Supported employment plus cognitive training

Supported employment for 12 months plus cognitive training for the first 12 weeks

Intervention Type BEHAVIORAL

Enhanced supported employment

Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role lead

Responsible Party

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Elizabeth W. Twamley, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth W Twamley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation

Locations

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VA San Diego Healthcare System

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26147236 (View on PubMed)

Other Identifiers

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PT075291

Identifier Type: -

Identifier Source: org_study_id

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