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Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population (TBI)

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ClinicalTrials.gov Identifier: NCT01118182
Recruitment Status : Unknown
Verified January 2016 by Lisa Brenner, VA Eastern Colorado Health Care System.
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2010
Last Update Posted : January 15, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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 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).


Condition or disease
Traumatic Brain Injury

Study Design

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes
Study Start Date : June 2009
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Traumatic Brain Injury (TBI)
Veterans with a positive history of TBI
No Traumatic Brain Injury (TBI)
Veterans with a negative history of TBI


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Indivduals with a history of completing the 4 Traumatic Brain Injury (TBI) screening questions during a mental health intake.
Criteria

Inclusion Criteria:

  • Veteran must be at least 18 years of age.
  • Veteran must have had a mental health intake no earlier than January of 2007.

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118182


Locations
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Colorado Traumatic Brain Injury Trust Fund
Ohio State University
University of Colorado, Denver
Investigators
Principal Investigator: Lisa A Brenner, PhD VA Office of Research and Development
More Information

Responsible Party: Lisa Brenner, Director, VA VISN 19 Mental Illness Research Education and Clinical Center (MIRECC), VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01118182     History of Changes
Other Study ID Numbers: COMIRB08-0001
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Lisa Brenner, VA Eastern Colorado Health Care System:
Traumatic Brain Injury
Veterans
Psychiatric Disorders
Suicide

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System