Post Traumatic Stress Disorder PTSD Clinical Trial
Official title:
A Randomized Controlled Trial Comparison of the Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries.
The specific aim of this proposed study is to compare the effectiveness of Vestibular Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain injuries in a randomized controlled trial in terms of PTSD symptom reduction.
The study has been approved by our Institutional IRB and conducted in accordance with the
principles of the Declaration of Helsinki. The trial will be registered at
Clinicaltrials.gov, a service of the U.S. National Institutes of Health. There is equipoise.
This randomized controlled trial will compare the effectiveness of VR in in patients with
PTSD who have suffered combat related traumatic brain injuries. A blinded investigator that
will not be involved in the study will perform the randomization and allocation procedure.
We will accomplish the specific aim of our study by analyzing the difference in the
Clinician Administered DSM-IV PTSD Scale (CAPS) scores between the two groups in our study
as outcomes to compare the effectiveness of VR. The CAPS is considered to be the gold
standard for diagnosing PTSD and assessing symptom severity. We expect differences in the
outcomes between both treatments to be immediate and at follow-up over time, i.e.
immediately after 3 months, 6 months and 12 months after cessation of a 2 week treatment
period. The study design will include one pre-treatment assessment and our post-treatment
assessments (at 3 months, 6 months and 12 months). Investigators who will be blinded for the
allocated treatment will perform all assessments. The study will be performed at the
department of Neurology of our Institutional Brain Center in Dallas, Texas. Patient
recruitment will begin starting in September 2014.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment