Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/8/2014 |
| Start Date: | March 2014 |
| End Date: | December 2014 |
| Contact: | Frederick R Carrick, PhD |
| Email: | drfrcarrick@gmail.com |
| Phone: | 214-771-8885 |
A Randomized Prospective Clinical Trial of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries
Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering
from post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators
will study PTSD treatment in military Veterans who have suffered traumatic brain injuries.
Investigators will use 2 independent specialty treatment centers that utilize different
methodology of PTSD treatments and study the clinical outcomes of veterans who have
suffered a TBI with associated post-concussive symptoms and other comorbidities such as
PTSD. Investigators hypothesize that the treatment of PTSD will have a better outcome with
neurological physical and vestibular rehabilitation when compared to psychological or
psychiatric therapy. This study will use gold standard measurement scales and compare
changes in the scales after treatment to evaluate the treatments.
from post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators
will study PTSD treatment in military Veterans who have suffered traumatic brain injuries.
Investigators will use 2 independent specialty treatment centers that utilize different
methodology of PTSD treatments and study the clinical outcomes of veterans who have
suffered a TBI with associated post-concussive symptoms and other comorbidities such as
PTSD. Investigators hypothesize that the treatment of PTSD will have a better outcome with
neurological physical and vestibular rehabilitation when compared to psychological or
psychiatric therapy. This study will use gold standard measurement scales and compare
changes in the scales after treatment to evaluate the treatments.
The Department of Defense and the Defense and Veteran's Brain Injury Center estimate that
22% of all combat casualties from conflicts in Iraq and Afghanistan are brain injuries.
Patients with TBI often meet criteria for PTSD on screening instruments for TBI and vice
versa. No screening instruments available can reliably make the diagnosis of PTSD and the
gold standard remains an interview by a skilled clinician using the Clinician-Administered
PTSD Scale (CAPS) a 30-item structured interview that corresponds to the Diagnostic and
Statistical Manual of Mental Disorders IV (DSM-IV) criteria for PTSD. Treatment for veterans
who have had a TBI and who are suffering from PTSD is varied with varied outcomes.
Investigators propose a Randomized Prospective Clinical Trial of PTSD treatment in military
Veterans that have suffered traumatic brain injuries. Investigators will use 2 independent
specialty treatment centers that utilize different methodology of PTSD treatments and study
the clinical outcomes of veterans who have suffered a TBI with associated post-concussive
symptoms and other comorbidities such as PTSD. This study will use a baseline CAPS
assessment and investigators will establish cut points and randomize from within those to
establish a stratified randomization within groups. Subjects will undergo treatments and an
outcome CAPS score will be obtained at the end of treatment as the primary outcome to
calculate if there is a change in score that is statistically or clinically significant.
Investigators also will utilize secondary outcomes to measure any changes in the scores
obtained by these instruments. These instruments and measures such as the Minnesota
Multiphasic Personality Inventory-2 (MMPI-2), Primary Care Post Traumatic Stress Syndrome
Screen (PC-PTSD), Beck Depression Inventory and Hamilton Rating Scale for Depression,
Computerized Dynamic Posturography and video electronystagmography and saccadometry will be
obtained before the initiation of treatment and when treatment is terminated to measure a
change in score. All instruments will be used to measure changes in function that are
related to changes in PTSD symptomatology and neurological function
22% of all combat casualties from conflicts in Iraq and Afghanistan are brain injuries.
Patients with TBI often meet criteria for PTSD on screening instruments for TBI and vice
versa. No screening instruments available can reliably make the diagnosis of PTSD and the
gold standard remains an interview by a skilled clinician using the Clinician-Administered
PTSD Scale (CAPS) a 30-item structured interview that corresponds to the Diagnostic and
Statistical Manual of Mental Disorders IV (DSM-IV) criteria for PTSD. Treatment for veterans
who have had a TBI and who are suffering from PTSD is varied with varied outcomes.
Investigators propose a Randomized Prospective Clinical Trial of PTSD treatment in military
Veterans that have suffered traumatic brain injuries. Investigators will use 2 independent
specialty treatment centers that utilize different methodology of PTSD treatments and study
the clinical outcomes of veterans who have suffered a TBI with associated post-concussive
symptoms and other comorbidities such as PTSD. This study will use a baseline CAPS
assessment and investigators will establish cut points and randomize from within those to
establish a stratified randomization within groups. Subjects will undergo treatments and an
outcome CAPS score will be obtained at the end of treatment as the primary outcome to
calculate if there is a change in score that is statistically or clinically significant.
Investigators also will utilize secondary outcomes to measure any changes in the scores
obtained by these instruments. These instruments and measures such as the Minnesota
Multiphasic Personality Inventory-2 (MMPI-2), Primary Care Post Traumatic Stress Syndrome
Screen (PC-PTSD), Beck Depression Inventory and Hamilton Rating Scale for Depression,
Computerized Dynamic Posturography and video electronystagmography and saccadometry will be
obtained before the initiation of treatment and when treatment is terminated to measure a
change in score. All instruments will be used to measure changes in function that are
related to changes in PTSD symptomatology and neurological function
Inclusion Criteria:
- Clinical diagnosis of PTSD
- History of Traumatic Brain Injury
- Military veteran of conflict in war zone
Exclusion Criteria:
- Criminal history of violence
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