Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With TBI, PTSD, or Both

This study is currently recruiting participants.
Verified July 2012 by VA Eastern Colorado Health Care System
Sponsor:
Collaborators:
Colorado Traumatic Brain Injury Trust Fund
University of Colorado, Boulder
Information provided by (Responsible Party):
VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01334463
First received: April 11, 2011
Last updated: July 25, 2012
Last verified: July 2012

April 11, 2011
July 25, 2012
July 2010
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Complete list of historical versions of study NCT01334463 on ClinicalTrials.gov Archive Site
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Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With TBI, PTSD, or Both
Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Both
  1. To determine whether tasks taken from the field of cognitive neuroscience can detect and distinguish impairments in executive function above and beyond standard neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI), b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD
  2. To determine whether performance on these tasks is linked to pertinent psychiatric outcomes (e.g. history of suicidality), which is associated with compromised executive function and impulsivity.
  3. To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.

Individuals who served in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) are reporting histories of traumatic brain injury (TBI) and symptoms associated with post traumatic stress disorder (PTSD). Standard neuropsychological measures are ineffective at distinguishing between TBI and PTSD. This pilot project will examine whether methods from cognitive neuroscience can determine the effects of TBI and/or PTSD on executive function. Executive function includes many aspects of goal-oriented behavior, including the ability to inhibit inappropriate behaviors and thoughts. In the proposed study, the investigators are focusing on inhibitory processing, as it is a core component of executive function. Although both TBI and PTSD compromise executive function and TBI often occurs in the context of a traumatic event, very little research has attempted to disentangle the effects that each of these conditions has on inhibitory control. In addition, the investigators are interested in how disinhibition may be linked to impulsive real-world behaviors, such as suicidal tendencies, which are observed at elevated rates in individuals with TBI as well as those with PTSD. Knowing the ways in which inhibitory functions are compromised in these individuals should aid in the development of appropriate treatments aimed at functional improvement for those with mild TBI, PTSD, or mild TBI+PTSD.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The participants in this observational study will be recruited from the following populations of OEF/OIF Veterans: 1.) those seeking mental health, rehabilitative, psychological or other services within the Veterans Health Administration (VHA) Eastern Colorado Healthcare System , 2.) those in existing clinical and research databases, and 3.) Veterans in the community not seeking care within the VHA.

  • Traumatic Brain Injury
  • Post Traumatic Stress Disorder
  • Suicide
  • Self-Injurious Behavior
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  • mTBI+PTSD
    History of active duty-related mild TBI and history of active duty-related PTSD
  • mTBI Only
    History of active duty-related mild TBI and no history of active duty-related PTSD
  • PTSD Only
    No history of active duty-related mild TBI and history of active duty-related PTSD
  • No mTBI, No PTSD
    No history of active duty-related mild TBI and no history of active duty-related PTSD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2013
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Inclusion Criteria:

  • Between the ages of 18-45 years old
  • At least one OEF/OIF deployment
  • Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System

Exclusion Criteria:

  • History of other significant neurological disease (other than mild TBI for the appropriate groups) as assessed by interview and chart review
  • History or diagnosis of lifetime moderate or severe TBI for the TBI groups, or any history of TBI for the non-TBI groups, as assessed by interview and chart review
  • History or diagnosis of non-active duty-related mild TBI or PTSD disorder as assessed by interview and/or chart review
  • Diagnosis of schizophrenia or bipolar I disorder as assessed by interview and/or chart review
  • Computerized Assessment of Response Bias (CARB) performance categorized as Very Poor or Symptom Exaggerator
  • Problematic drinking behavior that consistently exceeds recommended drinking limits per day, e.g., Diagnosis of Alcohol Abuse Disorder or Alcohol Dependence Disorder per the SCID; or five or more alcoholic drinks per day, four out of seven days per week for the previous two weeks
  • Use of illicit substance(s) more than five times in the two weeks before enrollment
  • Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure
  • Contraindication to having an MRI
Both
18 Years to 45 Years
Yes
Contact: Meghan J Calhoon, MS 303-399-8020 ext 3705 meghan.calhoon@va.gov
United States
 
NCT01334463
08-0502
No
VA Eastern Colorado Health Care System
VA Eastern Colorado Health Care System
  • Colorado Traumatic Brain Injury Trust Fund
  • University of Colorado, Boulder
Principal Investigator: Lisa A Brenner, Ph.D. Department of Veterans Affairs
VA Eastern Colorado Health Care System
July 2012

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