Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422, United States
NCT Number: NCT01816061
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD
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Notify Me21 year–55 year
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20422, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.
Increased hours of patient-provider interactions Group.
Other names: Supported discharge group
Time frame: Baseline and 2 months
Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)
Time frame: Baseline and 2 months
Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.
VA Office of Research and Development
Fed
Acronym: COMPASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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