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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by VA Eastern Colorado Health Care System.
Recruitment status was  Recruiting
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
  Purpose
  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.

Condition
Traumatic Brain Injury
Post Traumatic Stress Disorder
Suicide
Self-Injurious Behavior

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Both

Resource links provided by NLM:


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

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  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: NCT01334463

Contacts
Contact: Meghan J Calhoon, MS 303-399-8020 ext 3705 meghan.calhoon@va.gov

Locations
United States, Colorado
Denver VA Medical Denver Recruiting
Denver, Colorado, United States, 80220
Contact: Meghan J Calhoon, MS    303-399-8020 ext 3705    meghan.calhoon@va.gov   
Principal Investigator: Lisa A. Brenner, PhD         
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Colorado Traumatic Brain Injury Trust Fund
University of Colorado, Boulder
Investigators
Principal Investigator: Lisa A Brenner, Ph.D. Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01334463     History of Changes
Other Study ID Numbers: 08-0502
Study First Received: April 11, 2011
Last Updated: July 25, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Self-Injurious Behavior
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Suicide
Brain Injuries
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 21, 2014