Post-Traumatic Stress Disorder, Traumatic Brain Injury
Conditions
Keywords
Veterans Health, Social Adjustment, Traumatic Brain Injury (TBI), Post-Traumatic Stress Disorder (PTSD), Independent Living, Goals, Education
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).
Interventions
BEHAVIORALExperimental - COMPASS
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.
BEHAVIORALControl - COMPASS
Increased hours of patient-provider interactions Group.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Community Reintegration for Injured Service Members at 2 Months | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental - COMPASS 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.
Experimental - COMPASS: 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. | 27 |
| Control - COMMPASS Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status.
Control
Control - COMPASS: Increased hours of patient-provider interactions Group. | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 24 |
Baseline characteristics
| Characteristic | Control - COMMPASS | Total | Experimental - COMPASS |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 54 Participants | 27 Participants |
| Age, Continuous | 39.6 years STANDARD_DEVIATION 6.9 | 39.7 years STANDARD_DEVIATION 7.6 | 39.7 years STANDARD_DEVIATION 8.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 54 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 Participants | 54 Participants | 27 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 23 Participants | 45 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 51 |
| other Total, other adverse events | 0 / 40 | 0 / 51 |
| serious Total, serious adverse events | 0 / 40 | 0 / 51 |
Outcome results
Primary
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)
Time frame: Baseline and 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Experimental | Change From Baseline in Community Reintegration for Injured Service Members at 2 Months | 40.22 score on a scale | Standard Deviation 5.56 |
| Arm 1: Control | Change From Baseline in Community Reintegration for Injured Service Members at 2 Months | 37.79 score on a scale | Standard Deviation 6.04 |
Primary
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.
Time frame: Baseline and 2 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Arm 1: Experimental | Change From Baseline in Frontal Systems Behavior Scale at 2 Months | 85.4 score on a scale | Standard Deviation 12.2 |
| Arm 1: Control | Change From Baseline in Frontal Systems Behavior Scale at 2 Months | 84.3 score on a scale | Standard Deviation 13.12 |