Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS (NCT01816061) | Clinical Trial Compass
CompletedNot Applicable
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
United States91 participantsStarted 2014-03-12
Plain-language summary
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD
Who can participate
Age range21 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Change From Baseline in Community Reintegration for Injured Service Members at 2 Months
Timeframe: Baseline and 2 months
2
Change From Baseline in Frontal Systems Behavior Scale at 2 Months