Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries (PTSD-TBI)
Primary Purpose
PTSD, TBI
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Neurological Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring TBI, PTSD, Functional Neurology, Vestibular Rehabilitation, Dynamic Computerized Posturography, Saccadometry
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of PTSD
- History of Traumatic Brain Injury
- Military veteran of conflict in war zone
Exclusion Criteria:
- Criminal history of violence
Sites / Locations
- Carrick Brain Centers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Functional Neurological Rehabilitation
Arm Description
Functional Neurological and physical/vestibular rehabilitation strategies
Outcomes
Primary Outcome Measures
Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)
The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0-136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT02003352
First Posted
October 29, 2013
Last Updated
January 30, 2017
Sponsor
Carrick Institute for Graduate Studies
Collaborators
Carrick Brain Centers
1. Study Identification
Unique Protocol Identification Number
NCT02003352
Brief Title
Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries
Acronym
PTSD-TBI
Official Title
Evaluation of the Effectiveness of a Novel Brain and Vestibular Rehabilitation Treatment Modality in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carrick Institute for Graduate Studies
Collaborators
Carrick Brain Centers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 1 independent specialty treatment centers that utilize a specific novel 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 significant 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.
Detailed Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, TBI
Keywords
TBI, PTSD, Functional Neurology, Vestibular Rehabilitation, Dynamic Computerized Posturography, Saccadometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Neurological Rehabilitation
Arm Type
Experimental
Arm Description
Functional Neurological and physical/vestibular rehabilitation strategies
Intervention Type
Procedure
Intervention Name(s)
Functional Neurological Rehabilitation
Intervention Description
Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.
Primary Outcome Measure Information:
Title
Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)
Description
The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0-136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of PTSD
History of Traumatic Brain Injury
Military veteran of conflict in war zone
Exclusion Criteria:
Criminal history of violence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick R Carrick, PhD
Organizational Affiliation
Carrick IGS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carrick Brain Centers
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25699246
Citation
Carrick FR, McLellan K, Brock JB, Randall C, Oggero E. Evaluation of the Effectiveness of a Novel Brain and Vestibular Rehabilitation Treatment Modality in PTSD Patients Who have Suffered Combat-Related Traumatic Brain Injuries. Front Public Health. 2015 Feb 4;3:15. doi: 10.3389/fpubh.2015.00015. eCollection 2015.
Results Reference
background
PubMed Identifier
26082920
Citation
Carrick FR, Pagnacco G, McLellan K, Solis R, Shores J, Fredieu A, Brock JB, Randall C, Wright C, Oggero E. Short- and Long-Term Effectiveness of a Subject's Specific Novel Brain and Vestibular Rehabilitation Treatment Modality in Combat Veterans Suffering from PTSD. Front Public Health. 2015 Jun 1;3:151. doi: 10.3389/fpubh.2015.00151. eCollection 2015.
Results Reference
derived
Learn more about this trial
Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries
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