Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS (COMPASS)
Primary Purpose
Traumatic Brain Injury, Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental - COMPASS
Control - COMPASS
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Veterans Health, Social Adjustment, Traumatic Brain Injury (TBI), Post-Traumatic Stress Disorder (PTSD), Independent Living, Goals, Education
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.
Sites / Locations
- Washington DC VA Medical Center, Washington, DC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental - COMPASS
Control - COMPASS
Arm Description
Goal-setting sessions
Informative phone calls
Outcomes
Primary Outcome Measures
Change From Baseline in Community Reintegration for Injured Service Members at 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)
Change From Baseline in Frontal Systems Behavior Scale at 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01816061
First Posted
March 19, 2013
Last Updated
September 11, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01816061
Brief Title
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Acronym
COMPASS
Official Title
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2014 (Actual)
Primary Completion Date
March 6, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental - COMPASS
Arm Type
Experimental
Arm Description
Goal-setting sessions
Arm Title
Control - COMPASS
Arm Type
Active Comparator
Arm Description
Informative phone calls
Intervention Type
Behavioral
Intervention Name(s)
Experimental - COMPASS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control - COMPASS
Other Intervention Name(s)
Supported discharge group
Intervention Description
Increased hours of patient-provider interactions Group.
Primary Outcome Measure Information:
Title
Change From Baseline in Community Reintegration for Injured Service Members at 2 Months
Description
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
Title
Change From Baseline in Frontal Systems Behavior Scale at 2 Months
Description
Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.
Time Frame
Baseline and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Scholten, MD
Organizational Affiliation
DCVAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26664736
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.
Results Reference
result
PubMed Identifier
28206800
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28206800
Description
Libin, Scholten et al. Perspectives of veterans with mild traumatic brain injury on community reintegration
URL
https://www.ncbi.nlm.nih.gov/pubmed/26664736
Description
Libin, Scholten et al. Executive functioning in TBI from rehabilitation to social reintegration
Learn more about this trial
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
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