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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Colorado Traumatic Brain Injury Trust Fund
Ohio State University
University of Colorado, Denver
Information provided by (Responsible Party):
Lisa Brenner, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01118182
First received: May 4, 2010
Last updated: January 13, 2016
Last verified: January 2016

May 4, 2010
January 13, 2016
June 2009
December 2016   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01118182 on ClinicalTrials.gov Archive Site
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Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population
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).

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).

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Indivduals with a history of completing the 4 Traumatic Brain Injury (TBI) screening questions during a mental health intake.
Traumatic Brain Injury
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  • Traumatic Brain Injury (TBI)
    Veterans with a positive history of TBI
  • No Traumatic Brain Injury (TBI)
    Veterans with a negative history of TBI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118182
COMIRB08-0001
No
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Lisa Brenner, VA Eastern Colorado Health Care System
VA Eastern Colorado Health Care System
  • Colorado Traumatic Brain Injury Trust Fund
  • Ohio State University
  • University of Colorado, Denver
Principal Investigator: Lisa A Brenner, PhD VA Office of Research and Development
VA Eastern Colorado Health Care System
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP