Traumatic Brain InjuryTBINCT01118182
Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population
An observational study of Traumatic Brain Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 1,810 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Indivduals with a history of completing the 4 Traumatic Brain Injury (TBI) screening questions during a mental health intake.
Who may be able to join
- Veteran must be at least 18 years of age.
- Veteran must have had a mental health intake no earlier than January of 2007.
Who cannot join
- Failure to provide informed consent as evidenced by inability to respond to the above stated questions.
- No Mental Health Intake note in the medical record.
- Presence of a Mental Health Intake note in the computer which does not contain the TBI-4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes
The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).
Read the detailed description
The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).
Primary Hypotheses:
Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater than 0.75 and 0.80, respectively.
Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively.
Secondary Hypotheses:
Hypothesis 1c: The specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than that of the four questions alone.
Hypothesis 2: A significant difference in psychiatric outcomes (psychiatric hospitalizations, suicidal ideation, suicide attempts and completions, and mental health-related contacts) will be identified in those with a history of TBI versus those without a history of TBI as determined, first, by the TBI-4 and, second, by the OSU TBI-ID.
Hypothesis 3: The prevalence of Traumatic Brain Injury- Loss of Consciousness (TBI-LOC) in this population will be similar to that identified by Walker et al1 (31.7% of individuals will report 1 or more TBI-LOC).
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Veterans, Psychiatric Disorders, Suicide
- Medical subject headings
- Brain Injuries, Traumatic, Mental Disorders, Suicide
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 |
|---|---|---|
| Traumatic Brain Injury (TBI) | Veterans with a positive history of TBI | |
| No Traumatic Brain Injury (TBI) | Veterans with a negative history of TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ohio State University TBI Identification Method (OSU TBI-ID)
Structured clinical interview used as the gold standard for establishing a lifetime history of TBI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2016
- Study completionAug 2016
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund, Ohio State University, University of Colorado, Denver
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Lisa A Brenner, PhD, Principal investigator, VISN 19 MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118182
- Sponsor's protocol ID
- COMIRB08-0001
- Acronym
- TBI
- Status last verified
- Aug 2018
- First submitted
- 4 May 2010
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes
- ClinicalTrials.gov ID
- NCT01118182
- Acronym / sponsor ID
- TBI / COMIRB08-0001
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Veterans, Psychiatric Disorders, Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,810 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund, Ohio State University, University of Colorado, Denver
- Study start
- Jun 2009
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 May 2010 (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 primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).
Detailed description
The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).
Primary Hypotheses:
Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater than 0.75 and 0.80, respectively.
Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively.
Secondary Hypotheses:
Hypothesis 1c: The specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than that of the four questions alone.
Hypothesis 2: A significant difference in psychiatric outcomes (psychiatric hospitalizations, suicidal ideation, suicide attempts and completions, and mental health-related contacts) will be identified in those with a history of TBI versus those without a history of TBI as determined, first, by the TBI-4 and, second, by the OSU TBI-ID.
Hypothesis 3: The prevalence of Traumatic Brain Injury- Loss of Consciousness (TBI-LOC) in this population will be similar to that identified by Walker et al1 (31.7% of individuals will report 1 or more TBI-LOC).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury (TBI) | – | –Veterans with a positive history of TBI |
| No Traumatic Brain Injury (TBI) | – | –Veterans with a negative history of TBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indivduals with a history of completing the 4 Traumatic Brain Injury (TBI) screening questions during a mental health intake.
Key inclusion criteria (2 listed)
- Veteran must be at least 18 years of age.
- Veteran must have had a mental health intake no earlier than January of 2007.
Key exclusion criteria (3 listed)
- Failure to provide informed consent as evidenced by inability to respond to the above stated questions.
- No Mental Health Intake note in the medical record.
- Presence of a Mental Health Intake note in the computer which does not contain the TBI-4
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
Ohio State University TBI Identification Method (OSU TBI-ID)
Time frame: 1 day
Structured clinical interview used as the gold standard for establishing a lifetime history of TBI
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 14 Aug 2018.
- Rocky Mountain MIRECC websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
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, 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 2 inclusion and 3 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 14 Aug 2018. 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?
Ohio State University TBI Identification Method (OSU TBI-ID) (time frame: 1 day). 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 14 Aug 2018.