N/A
N=91
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Traumatic Brain Injury · Post-Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01816061 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change From Baseline in Community Reintegration for Injured Service Members at 2 Months — 40.22; 37.79 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental - COMPASS (Behavioral); Control - COMPASS (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Community Reintegration for Injured Service Members at 2 Months |
40.22; 37.79 | — |
| PRIMARY Change From Baseline in Frontal Systems Behavior Scale at 2 Months |
85.4; 84.3 | — |
Summary
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01816061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.