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

NCT01334463 | Completed

• 1 other identifier: 08-0502
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Iowa Gambling Test

  One time

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• Colorado Traumatic Brain Injury Trust Fund: collaborator
• University of Colorado, Boulder: collaborator

Study Sites (1)

Denver VA Medical Denver

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lisa A Brenner, Ph.D.

  VA Office of Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: July 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 25, 2016

Record last verified: 2016-01

Locations

US (1)