Improving Work Outcomes for Veterans With Traumatic Brain... | NCT00704067

Studies
Improving Work Outcomes for Veterans With Traumatic Brain Injury

NCT00704067

Sponsor

United States Department of Defense

Status

Completed

Last Update Posted

Feb 12, 2015Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Traumatic Brain Injury

Interventions

Supported employment plus cognitive training
Enhanced supported employment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 20, 2008

First Submission Date that Met QC Criteria

Jun 20, 2008

First Posted Date

Jun 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2015

Last Update Posted Date

Feb 12, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth W. Twamley, PhD, Principal Investigator, United States Department of DefensePrincipal Investigator

Lead Sponsor

United States Department of DefenseFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Supported employment for 12 months plus cognitive training for the first 12 weeks	Behavioral: Supported employment plus cognitive training
2	Active Comparator	Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks	Behavioral: Enhanced supported employment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supported employment plus cognitive training	Behavioral	Supported employment for 12 months plus cognitive training for the first 12 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weeks worked		12 months

Secondary Outcomes

Measure	Description	Time Frame
Hours worked		12 months
Dollars earned from working		12 months
Cognitive performance

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth W Twamley, PhD	University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA San Diego Healthcare System		San Diego	California	92161	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26147236	Derived	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.

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D016832	Employment, Supported
D000091942	Cognitive Training

ID	Term
D004651	Employment
D012959	Socioeconomic Factors
D011154	Population Characteristics
D012050	Rehabilitation, Vocational