Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Eric Elbogen, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01410721
First received: August 3, 2011
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

Up to half of all military service members with combat-related traumatic brain injury (TBI) also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with cognitive problems in what are called 'executive functions' such as planning actions, inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems day-to-day. These types of impairments occur more often among veterans with both TBI and PTSD than among those with only one of these conditions. The combination of TBI and PTSD in veterans has also been linked to problems with anger and violence, which are common complaints of veterans seeking mental health services post-deployment and have been shown to predict poor treatment outcomes in Iraq and Afghanistan veterans.

Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment problems has been demonstrated, there has been little research into clinical interventions designed to reduce the severity of cognitive and affective symptoms in veterans with both TBI and PTSD. Therefore, the investigators propose a randomized clinical trial involving a cognitive rehabilitation intervention that targets improved executive functioning, with the participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group and n=50 comparison).

As part of the study, all participants will receive an iPod touch. Participants will be placed into one of the two study groups randomly. Based on which group participants are placed in, they will receive one of two different sets of iPod touch apps and programs that address and aim to improve different facets of cognitive functioning. Regardless of which group, Veterans will be instructed to daily practice iPod touch applications on cognitive functioning. Also, family members will be trained as "mentors" to reinforce use of the applications in everyday living environments. Trained facilitators will also travel to participants' homes to meet with veterans and family to observe behaviors in the home environment, arrive at strategies for applying new skills in their situations, troubleshoot any iPod technical problems, and review family mentoring processes.

The investigators will measure clinical outcomes using a comprehensive array of functional and structural methods at baseline and six months. The investigators hypothesize improved executive function among those in the experimental group as well as reduced irritability/impulsivity and improved social/occupational functioning. The investigators further hypothesize that, as a group, veterans participating in the cognitive rehabilitation program will show significant changes in neural activity associated with executive functions when comparing pre- and post-treatment EEG and fMRI responses.

Better understanding of the neural circuitry and neurocognitive function underlying executive function and associated affective control deficits in veterans with both TBI and PTSD, and how they relate to treatment outcome, will allow us to better identify therapeutic targets for cognitive rehabilitation. The current proposal aims to explore the relationship between brain function and connectivity in selective pathways/circuits, neuropsychological functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD.

This study of the neurobiology and neuropsychology associated with intervention efficacy will allow us to identify veterans with both TBI and PTSD who are predisposed to positive treatment outcomes. To our knowledge, this will be the first attempt to integrate neurobiological and neurocognitive techniques with information about the efficacy of a theoretically and empirically driven cognitive rehabilitation intervention in veterans with combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of clinical intervention efficacy and the identification of therapeutic targets (e.g. alteration of function in fronto-limbic circuits) relevant to the military population. Given links between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression, efforts to rehabilitate cognitive function will be particularly important to ensure that current and future veterans adjust successfully when they return home to their families, workplaces, and communities.


Condition Intervention
Traumatic Brain Injury
Posttraumatic Stress Disorder
Behavioral: Cognitive Rehabilitation Intervention
Behavioral: Cognitive Rehabilitation Control Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Markers and Rehabilitation of Executive Functioning in Veterans With TBI and PTSD

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Executive Function [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Executive function is hypothesized to be improved in the experimental group, as evidenced by increased scores on neuropsychological measures from Dellis-Kaplan Executive Functioning System.


Secondary Outcome Measures:
  • Impulsivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    It is hypothesized that participants in the experimental group will shown reduced impulsivity, as measured by the Barrat Impulsivity Scale.

  • Interpersonal Conflict [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    It is hypothesized that participants in the experimental group will shown reduced interpersonal conflict, as measured by the Conflict Tactics Scale.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Rehabilitation Intervention
Baseline training and follow-up at two months and four months.
Behavioral: Cognitive Rehabilitation Intervention
Baseline training and follow-up at two months and four months.
Active Comparator: Cognitive Rehabilitation Control Arm
Baseline training and follow-up at two months and four months.
Behavioral: Cognitive Rehabilitation Control Intervention
Baseline training and follow-up at two months and four months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

OIF/OEF Veteran inclusion criteria include:

  1. has served in one of the military branches (Army, Navy, Marines, Air Force, National Guard);
  2. is between the ages of 18 and 65;
  3. has served in Iraq or Afghanistan War since October 2001;
  4. has screened positive for TBI and PTSD prior to baseline interview. Definition of TBI: The American Congress of Rehabilitation Medicine (ACRM) (Kay et al., 1993), Center for Disease Control (CDC, 2003), and Military TBI Task Force (http://www.div40.org/pdf/Military_TBI.pdf) have sought to define criteria for different types of head injuries. In the current DoD application, for both the research registry and pre-screening, criteria for TBI should be defined as a veteran who: 1. reports that during military service, head was hurt/injured in a way that caused problems; AND 2. endorses at least one of the following:

    • loss of consciousness or getting "knocked out."
    • immediately after the injury or upon regaining consciousness, being dazed or "seeing stars."
    • immediately after the injury or upon regaining consciousness, being unable to recall the event.
    • being over one hour after the injury was it before veteran started remembering new things again.
    • needing brain surgery after the injury.

Definition of PTSD: For the purposes of the current research, we use the Diagnostic Statistical Manual-IV-TD (DSM-IV-TR) definition of PTSD for the purposes of the current research. Specifically, subjects must report a traumatic event according to DSM criteria and report experiencing re-experiencing, avoidance, and hyperarousal symptoms to qualify for the diagnosis. Study registries define PTSD as having a score above the cut-off of 60 on the Clinical Assessment of PTSD (CAPS). We will re-screen potential participants before enrollment by administering the PTSD Checklist, scores above 50 indicative of PTSD among OIF/OEF veterans. Please note below that the CAPS will be administered as part of the main clinical interview after veterans have signed informed consent.

Family member inclusion criteria include: (1) has family member/friend who served in one of the military branches (Army, Navy, Marines, Air Force, National Guard); (2) age 18-65; and (3) has family member who served at least one tour in Iraq or Afghanistan since October 2001 and meets above criteria Inclusion of Women and Minorities in Study: It is anticipated that the distribution of our sample by gender and race/ethnicity will reflect the client population served by the North Carolina healthcare system. No one will be excluded from the study because of gender or racial/ethnic group.

Exclusion Criteria:

Since MRI sessions are a part of the study, subjects should not participant if:

  1. They have any foreign metal objects or implants in their body as determined by the safety questionnaires.
  2. Veteran is a woman and is pregnant or unwilling to take a pregnancy test.
  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: NCT01410721

Contacts
Contact: Eric B. Elbogen, Ph.D (919) 972-7458 eric.elbogen@unc.edu

Locations
United States, North Carolina
UNC Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Eric B. Elbogen, Ph.D    919-972-7458    eric.elbogen@unc.edu   
Principal Investigator: Eric B. Elbogen, Ph.D         
Sub-Investigator: Ayse Belger, Ph.D         
Sub-Investigator: Robert Hamer, Ph.D         
Sub-Investigator: Sally Johnson, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Eric B. Elbogen, Ph.D UNC
  More Information

No publications provided

Responsible Party: Eric Elbogen, PhD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01410721     History of Changes
Other Study ID Numbers: PT100071
Study First Received: August 3, 2011
Last Updated: August 29, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
TBI
PTSD
Veterans

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 15, 2014