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NCT01410721 · ClinicalTrials.gov registry record · NA
Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder
A NA study of Traumatic Brain Injury and Posttraumatic Stress Disorder, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 241
- Enrollment target
- 1
- Study location
NCT01410721 is a NA study of Traumatic Brain Injury and Posttraumatic Stress Disorder that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 241 participants, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01410721, a NA study of Traumatic Brain Injury and Posttraumatic Stress Disorder, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 241 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Rehabilitation Intervention
- BEHAVIORAL Cognitive Rehabilitation Control Intervention
Study Locations (1)
North Carolina
- UNC - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01410721
The ClinicalTrials.gov registry entry for NCT01410721 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (13% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Rehabilitation Intervention is the first listed.
NCT01410721 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01410721 about?
NCT01410721 is a clinical study titled "Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder". 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, monitori...
What is the current status of trial NCT01410721?
This trial is currently completed. It is a NA study. The enrollment target is 241 participants. The study started on 2012-01. Estimated completion is 2016-02.
What conditions does trial NCT01410721 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT01410721?
The interventions under investigation include: Cognitive Rehabilitation Intervention (BEHAVIORAL), Cognitive Rehabilitation Control Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01410721?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01410721 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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