- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01334463
Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With TBI, PTSD, or Both
January 22, 2016 updated by: VA Eastern Colorado Health Care System
Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Both
- 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
- 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.
- To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
186
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
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Colorado
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Denver, Colorado, United States, 80220
- Denver VA Medical Denver
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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 to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
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: Prospective
Cohorts and Interventions
Group / Cohort |
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mTBI+PTSD
History of active duty-related mild TBI and history of active duty-related PTSD
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mTBI Only
History of active duty-related mild TBI and no history of active duty-related PTSD
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PTSD Only
No history of active duty-related mild TBI and history of active duty-related PTSD
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No mTBI, No PTSD
No history of active duty-related mild TBI and no history of active duty-related PTSD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Iowa Gambling Test
Time Frame: One time
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One time
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa A Brenner, Ph.D., VA Office of Research and Development
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
July 1, 2010
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 11, 2011
First Submitted That Met QC Criteria
April 12, 2011
First Posted (Estimate)
April 13, 2011
Study Record Updates
Last Update Posted (Estimate)
January 25, 2016
Last Update Submitted That Met QC Criteria
January 22, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Trauma and Stressor Related Disorders
- Brain Injuries
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Brain Injuries, Traumatic
- Suicide
- Self-Injurious Behavior
Other Study ID Numbers
- 08-0502
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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