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

August 10, 2018 updated by: Lisa Brenner, VA Eastern Colorado Health Care System

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).

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

1810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lisa A Brenner, PhD, Visn 19 Mirecc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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