NCT01118182

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,810

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

7.2 years

First QC Date

May 4, 2010

Last Update Submit

August 10, 2018

Conditions

Keywords

Traumatic Brain InjuryVeteransPsychiatric DisordersSuicide

Outcome Measures

Primary Outcomes (1)

  • Ohio State University TBI Identification Method (OSU TBI-ID)

    Structured clinical interview used as the gold standard for establishing a lifetime history of TBI

    1 day

Study Arms (2)

Traumatic Brain Injury (TBI)

Veterans with a positive history of TBI

No Traumatic Brain Injury (TBI)

Veterans with a negative history of TBI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Indivduals with a history of completing the 4 Traumatic Brain Injury (TBI) screening questions during a mental health intake.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticMental DisordersSuicide

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Lisa A Brenner, PhD

    VISN 19 MIRECC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, VA VISN 19 Mental Illness Research Education and Clinical Center (MIRECC)

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 6, 2010

Study Start

June 1, 2009

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations