Traumatic Brain InjuryCOMPASSNCT01816061
Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
A study testing Experimental - COMPASS in people with Traumatic Brain Injury and Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Post-Traumatic Stress Disorder
- What is being tested?
- Experimental - COMPASS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2014to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD
Read the 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).
- Being tested
- Experimental - COMPASS, Control - COMPASS
- Keywords
- Veterans Health, Social Adjustment, Traumatic Brain Injury (TBI), Post-Traumatic Stress Disorder (PTSD), Independent Living, Goals, Education
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - COMPASSBehavioural
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.
Control - COMPASSBehavioural
Also called Supported discharge group
Increased hours of patient-provider interactions Group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - COMPASS | Experimental | Goal-setting sessions Receives: Behavioral: Experimental - COMPASS |
| Control - COMPASS | Active comparator | Informative phone calls Receives: Behavioral: Control - COMPASS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 2 months
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.
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study start12 Mar 2014
- Primary completion6 Mar 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joel Scholten, MD, Principal investigator, DCVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816061
- Sponsor's protocol ID
- D0637-R
- Acronym
- COMPASS
- Status last verified
- Sep 2019
- First submitted
- 19 Mar 2013
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26664736Libin 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.
PubMed 28206800
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
- ClinicalTrials.gov ID
- NCT01816061
- Acronym / sponsor ID
- COMPASS / D0637-R
- Keywords
- Veterans Health, Social Adjustment, Traumatic Brain Injury (TBI), Post-Traumatic Stress Disorder (PTSD), Independent Living, Goals, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - COMPASS | Experimental | Behavioral: Experimental - COMPASSGoal-setting sessions |
| Control - COMPASS | Active comparator | Behavioral: Control - COMPASSInformative phone calls |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- History of substance abuse severe enough to cause neurologic damage, pre-morbid history of neurologic disease (e.g., stroke).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental - COMPASSControlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks. | Behavioural | Experimental - COMPASS |
| Control - COMPASSAlso: Supported discharge groupIncreased hours of patient-provider interactions Group. | Behavioural | Control - COMPASS |
Primary outcome
Change From Baseline in Community Reintegration for Injured Service Members at 2 Months
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)
Change From Baseline in Frontal Systems Behavior Scale at 2 Months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26664736Libin 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 publication: PubMed 28206800Libin 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.
- Libin, Scholten et al. Perspectives of veterans with mild traumatic brain injury on community reintegrationLink provided by the sponsor.
- Libin, Scholten et al. Executive functioning in TBI from rehabilitation to social reintegrationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Scholten, MD principal investigator
DCVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental - COMPASS in people with Traumatic Brain Injury and Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Community Reintegration for Injured Service Members at 2 Months (time frame: Baseline and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.