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Clinical Trial Summary

Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD


Clinical Trial 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 for VA community re-integration comparative effectiveness research. The COMPASSgoal intervention will be developed and implemented to meet these needs. COMPASSgoal will integrate principles and best practices of goal self-management. Goal setting is a core skill in self-management training by which persons with chronic health conditions learn to improve their status and decrease symptom impact.3F One important mechanism of action of this program appears to be its positive effect on self-efficacy, or confidence in one's ability to attain goals and solve problems.4F

The study goal is to gather data on the efficacy of a novel approach to psychosocial rehabilitation for Veterans with executive function impairment due to traumatic brain injury (TBI), and to explore over time, through relevant measures, Veteran responsiveness to intervention. Veterans with mild TBI will be randomized into two groups: the COMPASS (Community Participation through Self-Efficacy Skills Development) goal-management intervention group and the supported discharge group.

110 participants with residual deficits in executive function due to TBI will be recruited at a minimum of 3 months post-injury from the TBI program at the DC VAMC over the three-year period of the study. The operational definition of executive dysfunction/ inclusion into the study is based on both clinical diagnosis by a study physician and a standardized executive dysfunction measure, the Frontal Systems Rating Scale (FrSBe score), such that a total score or any of the 3 subscale scores < 1 SD compared to the normative score would indicate executive dysfunction sufficient to include in the study. The treatment phase for the Veterans enrolled in the intervention group will continue for two consecutive months (8 weekly sessions). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01816061
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date March 12, 2014
Completion date March 31, 2018

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