Traumatic Brain InjuryNCT01502852
Identifying the Needs of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues
An observational study of Traumatic Brain Injury and Co-Occurring Behavioral Health Issues, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Co-Occurring Behavioral Health Issues
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Nov 2014
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: OEF/OIF Veterans with a history of TBI, their family members/friends, and community mental health providers working with these Veterans.
Who may be able to join
- Colorado Behavioral Health Organization (BHO) mental health providers
- OEF/OIF United States Veterans
- Family members and/or friends of OEF/OIF United States Veterans
- Ages 18-65
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying the Needs of OEF/OIF Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues
The purpose of this study is to explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health issues.
Read the detailed description
The focus of this project is on qualitative data collection to facilitate product development including assessment and treatment guidelines to improve non-VA community mental health care for OEF/OIF Veterans with TBI and co-occurring behavioral health issues within the state of Colorado. In addition to the development of assessment and treatment guidelines, other products developed through this study will include a training and accompanying toolkit, which may be used for annual educational training of mental health providers. As such, there are no hypotheses associated with this study. This statewide initiative may not only improve quality and access to non-VA community mental health care for persons with TBI and co-occurring behavioral health issues within Colorado, but also serve as a model for implementation across the country.
- Keywords
- OEF/OIF Veterans, Traumatic Brain Injury, Community Mental Health
- 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.
| Study group | Role | What they receive |
|---|---|---|
| OEF/OIF Veterans with TBI | Not described | |
| Family Members and Friends | Family Members and Friends of OEF/OIF Veterans with TBI | |
| Community Mental Health Center Providers | Community Mental Health Center providers working with OEF/OIF Veterans with TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus Groups
Measured: One Time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Ecologic or community
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Lisa A Brenner, PhD, Principal investigator, VISN 19 MIRECC; University of Colorado, School of Medicine, Dept. of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502852
- Sponsor's protocol ID
- 11-0720
- Other IDs
- PO IHA TBIP1125855
- Status last verified
- Nov 2014
- First submitted
- 29 Dec 2011
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Needs of OEF/OIF Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues
- ClinicalTrials.gov ID
- NCT01502852
- Acronym / sponsor ID
- 11-0720
- Keywords
- OEF/OIF Veterans, Traumatic Brain Injury, Community Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Aug 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Jan 2012 (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 purpose of this study is to explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health issues.
Detailed description
The focus of this project is on qualitative data collection to facilitate product development including assessment and treatment guidelines to improve non-VA community mental health care for OEF/OIF Veterans with TBI and co-occurring behavioral health issues within the state of Colorado. In addition to the development of assessment and treatment guidelines, other products developed through this study will include a training and accompanying toolkit, which may be used for annual educational training of mental health providers. As such, there are no hypotheses associated with this study. This statewide initiative may not only improve quality and access to non-VA community mental health care for persons with TBI and co-occurring behavioral health issues within Colorado, but also serve as a model for implementation across the country.
Study design
- Observational model
- Ecologic or community
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OEF/OIF Veterans with TBI | – | – |
| Family Members and Friends | – | –Family Members and Friends of OEF/OIF Veterans with TBI |
| Community Mental Health Center Providers | – | –Community Mental Health Center providers working with OEF/OIF Veterans with TBI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- OEF/OIF Veterans with a history of TBI, their family members/friends, and community mental health providers working with these Veterans.
Key inclusion criteria (4 listed)
- Colorado Behavioral Health Organization (BHO) mental health providers
- OEF/OIF United States Veterans
- Family members and/or friends of OEF/OIF United States Veterans
- Ages 18-65
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Focus Groups
Time frame: One Time
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 25 Nov 2014.
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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.
Lisa A Brenner, PhD principal investigator
VISN 19 MIRECC; University of Colorado, School of Medicine, Dept. of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Co-Occurring Behavioral Health Issues, run by VA Eastern Colorado Health Care System 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 4 inclusion and 1 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 25 Nov 2014. 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?
Focus Groups (time frame: One Time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2014.