Status:
COMPLETED
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Lead Sponsor:
VA Office of Research and Development
Conditions:
Traumatic Brain Injury
Post-Traumatic Stress Disorder
Eligibility:
All Genders
21-55 years
Phase:
NA
Brief Summary
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD
Detailed Description
The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform...
Eligibility Criteria
Inclusion
- TBI of at least mild severity using criteria related to disturbance of consciousness (VHA TBI Comprehensive Evaluation screening tool).
- Obtained informed consent.
- Males or females of working age, between the ages of 18 and 55.
- Medically stable with physician approval to participate
- Ability to comprehend and communicate in English at a 6th grade level
- Executive dysfunction as identified by Frontal Systems Rating Scale (FrSBe) and/or other study assessments
Exclusion
- Unable to provide informed consent and no proxy available.
- Severe impairment of language or day- to-day memory that would preclude participation in a verbally-based therapy.
- Life expectancy of less than 36 months.
- Severe multiple trauma (as judged by the attending physicians and/or investigators that is too severe to participate in this study) such as:
- severe burns
- serious organ damage
- amputations
- multiple fractures
- History of substance abuse severe enough to cause neurologic damage, pre-morbid history of neurologic disease (e.g., stroke).
- Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness as determined by medical history.
Key Trial Info
Start Date :
March 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01816061
Start Date
March 12 2014
End Date
March 31 2018
Last Update
September 25 2019
Active Locations (1)
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1
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States, 20422