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

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Denver

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Iowa Gambling Test
Time Frame: One time
One time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Eastern Colorado Health Care System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Boulder
Colorado Traumatic Brain Injury Trust Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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