Trial Outcomes & Findings for Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries (NCT NCT02003352)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2017-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Functional Neurological Rehabilitation Functional Neurological and physical/vestibular rehabilitation strategies Functional Neurological Rehabilitation: 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.
Overall Study STARTED	98
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Functional Neurological Rehabilitation n=98 Participants Functional Neurological and physical/vestibular rehabilitation strategies Functional Neurological Rehabilitation: 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. The study population consisted of 98 combat veterans who had suffered aT BI with PTSD, referred to our study by Veteran's groups. All subjects were male with a mean age of 39 years with a minimum age of 20 years and a maximum age of 60 years.They all met the inclusion requirements and did not have any of the exclusion requirements.
Sex: Female, Male Male	98 Participants n=99 Participants
Region of Enrollment United States	98 participants n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	98 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	39 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Changes in CAPS scores before-after. Frequency and intensity scores combined-CAPS score (range: 0-136) . CAPS pre-intervention, 1 week post-intervention, and at 3 months post-intervention. Difference pre and post of CAPS Scores (matched pairs) two-tailed t -Test with alpha of \<0.05. Effect Size Cohen's D

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.

Outcome measures

Outcome measures
Measure	Functional Neurological Rehabilitation n=98 Participants Functional Neurological and physical/vestibular rehabilitation strategies Functional Neurological Rehabilitation: 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.
Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)	73.13 units on a scale Interval 69.17 to 77.09

Adverse Events

Functional Neurological Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Frederick R Carrick

Brain Synergy Institute

Phone: 321-868-6464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place