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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 Post Traumatic Stress Disorder and Traumatic Brain Injury, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 241
- Enrollment target
- 1
- Study location
NCT01410721: Completed NA study of Post Traumatic Stress Disorder and Traumatic Brain Injury, sponsored by University of North Carolina, Chapel Hill.
NCT01410721 is a NA study of Post Traumatic Stress Disorder and Traumatic Brain Injury that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 241 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410721, a NA study of Post Traumatic Stress Disorder and Traumatic Brain Injury, 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
Primary Outcome
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.
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 |
What the finished NCT01410721 record still lists
NCT01410721 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Rehabilitation Intervention is the first listed.
NCT01410721 reports a single indexed study location in 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: Post Traumatic Stress Disorder, Traumatic Brain Injury.
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.
Learn More About Clinical Trials
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Where NCT01410721's enrollment target sits among peer trials
241 41st of 262 higher than 222 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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