Traumatic Brain InjuryNCT00704067
Improving Work Outcomes for Veterans With Traumatic Brain Injury
A study testing Supported employment plus cognitive training and Enhanced supported employment in people with Traumatic Brain Injury, run by United States Department of Defense at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Supported employment plus cognitive training and Enhanced supported employment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current alcohol/substance abuse or dependence
- Participation in other intervention studies
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Supported employment plus cognitive training, Enhanced supported employment
- Keywords
- vocational rehabilitation, supported employment, cognitive training, cognitive remediation, cognitive rehabilitation, veterans
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported employment plus cognitive trainingBehavioural
Supported employment for 12 months plus cognitive training for the first 12 weeks
Enhanced supported employmentBehavioural
Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Supported employment for 12 months plus cognitive training for the first 12 weeks Receives: 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 Receives: Behavioral: Enhanced supported employment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weeks worked
Measured: 12 months
Secondary outcomes (5)
Hours worked
Measured: 12 months
Dollars earned from working
Measured: 12 months
Cognitive performance
Measured: 3, 6, and 12 months
Neurobehavioral symptoms
Measured: 3, 6, and 12 months
Quality of life
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Elizabeth W. Twamley, PhD, United States Department of Defense
- Investigators
- Elizabeth W Twamley, PhD, Principal investigator, University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704067
- Sponsor's protocol ID
- PT075291
- Status last verified
- Feb 2015
- First submitted
- 20 Jun 2008
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26147236
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Work Outcomes for Veterans With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00704067
- Acronym / sponsor ID
- PT075291
- Conditions
- Traumatic Brain Injury
- Keywords
- vocational rehabilitation, supported employment, cognitive training, cognitive remediation, cognitive rehabilitation, veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Supported employment plus cognitive trainingSupported employment for 12 months plus cognitive training for the first 12 weeks |
| 2 | Active comparator | Behavioral: Enhanced supported employmentSupported employment for 12 months plus one additional supported employment session per week for the first 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Current alcohol/substance abuse or dependence
- Participation in other intervention studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supported employment plus cognitive trainingSupported employment for 12 months plus cognitive training for the first 12 weeks | Behavioural | 1 |
| Enhanced supported employmentSupported employment for 12 months plus one additional supported employment session per week for the first 12 weeks. | Behavioural | 2 |
Primary outcome
Weeks worked
Time frame: 12 months
5 secondary outcomes
Hours worked
Time frame: 12 months
Dollars earned from working
Time frame: 12 months
Cognitive performance
Time frame: 3, 6, and 12 months
Neurobehavioral symptoms
Time frame: 3, 6, and 12 months
Quality of life
Time frame: 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Derived from this study: PubMed 26147236Walter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth W Twamley, PhD principal investigator
University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported employment plus cognitive training and Enhanced supported employment in people with Traumatic Brain Injury, run by United States Department of Defense at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weeks worked (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00704067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.