Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Condition: Traumatic Brain Injury; Post-Traumatic Stress Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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 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).
    

Intervention name(s): Experimental - COMPASS; Control - COMPASS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 intervention name(s): Supported discharge group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Veterans Health; Social Adjustment; Traumatic Brain Injury (TBI); Post-Traumatic Stress Disorder (PTSD); Independent Living; Goals; Education