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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by VA Eastern Colorado Health Care System.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Colorado Traumatic Brain Injury Trust Fund Program
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 3, 2012
Last verified: April 2011
  Purpose

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
Traumatic Brain Injury

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Traumatic Brain Injury (TBI)
Veterans with a positive history of TBI
No Traumatic Brain Injury (TBI)
Veterans with a negative history of TBI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Program
Ohio State University
University of Colorado, Denver
Investigators
Principal Investigator: Lisa A Brenner, PhD Department of Veterans Affairs
  More Information

No publications provided

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
Study First Received: May 4, 2010
Last Updated: January 3, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 28, 2014