Clinical trial NCT01816061: Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Official title: Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Post-Traumatic Stress Disorder
Keywords: Veterans Health
Social Adjustment
Traumatic Brain Injury (TBI)
Post-Traumatic Stress Disorder (PTSD)
Independent Living
Goals
Education
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-03-21
Enrollment: 91
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Primary outcomes:
measure: Change From Baseline in Community Reintegration for Injured Service Members at 2 Months
timeFrame: Baseline and 2 months
measure: Change From Baseline in Frontal Systems Behavior Scale at 2 Months
timeFrame: Baseline and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
Study officials:
affiliation: DCVAMC
name: Joel Scholten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Libin AV, Scholten J, Schladen MM, Danford E, Shara N, Penk W, Grafman J, Resnik L, Bruner D, Cichon S, Philmon M, Tsai B, Blackman M, Dromerick A. Executive functioning in TBI from rehabilitation to social reintegration: COMPASS (goal,) a randomized controlled trial (grant: 1I01RX000637-01A3 by the VA ORD RR&D, 2013-2016). Mil Med Res. 2015 Nov 30;2:32. doi: 10.1186/s40779-015-0061-2. eCollection 2015.
citation: Libin AV, Schladen MM, Danford E, Cichon S, Bruner D, Scholten J, Llorente M, Zapata S, Dromerick AW, Blackman MR, Magruder KM. Perspectives of veterans with mild traumatic brain injury on community reintegration: Making sense of unplanned separation from service. Am J Orthopsychiatry. 2017;87(2):129-138. doi: 10.1037/ort0000253.