Translational Research Center for TBI and Stress Disorders: Virtual Assessment of Deployment Trauma and Rehabilitation
NCT ID: NCT04723745
Last Updated: 2021-01-26
Study Results
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Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-12-08
2024-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VTRACTS
We will target post-9/11 Veterans with TBI or blast exposure who self-report ongoing post-concussive neurobehavioral symptoms, but V-TRACTS will be open to all post-9/11 Veterans irrespective of any diagnoses.
V-TRACTS Assessment/Feedback
The proposed V-TRACTS assessment strategically targets emotional, cognitive and behavioral functions that we have determined are highly predictive of long-term outcome in Veterans. The assessment targets domains of head injury, psychological trauma, depression, suicidality, anxiety, chronic pain and sleep, substance use and activity level. This assessment will, in most cases, be completed online using the Qualtrics platform and online using telehealth or other approved platform for the clinical interview. Once the assessment is complete, the clinical team will convene a consensus meeting to review the case and determine a course of recommended additional assessment and/or rehabilitation action. After a consensus is reached, a V-TRACTS psychologist/supervised fellow will provide comprehensive feedback encompassing the entire assessment battery and offer rehabilitation options that would be targeted to the individual veteran's needs via VA telehealth or other approved online service.
OPTIONAL Brief Assessment of Thinking
A neuropsychological/cognitive assessment will be conducted to gather information about functioning in the areas of memory, attention, and thinking. This assessment is designed to be done online in a single session, and it will take approximately 45-90 minutes to complete. The test battery is designed to focus on the specific cognitive abilities thought to be impacted by blast, mTBI, PTSD, etc. This battery is not intended to be an exhaustive assessment of all neuropsychological functions.
OPTIONAL STEP-Home-Brief
STEP-Home-Brief is a condensed version of the 12-week experimental program STEP-Home that will target four core skills (problem solving, emotional regulation, attention training, and health and wellness). It will be individualized to Veterans' problems: vocation/career, community reintegration, psychoeducation to destigmatize barriers to mental health, substance misuse, anger management, and family and intimate partner relationships. STEP-Home-Brief will include 1-3 sessions using the same treatment modules as the 12-week program in a condensed, targeted format.
OPTIONAL At-home Exercise Program
This is a 5-week, full-body exercise program that can be done in the convenience of the Veteran's home, using only bodyweight as resistance and with household items as equipment. Given the online delivery of this program, they will receive access to instructional videos and materials that demonstrate how to perform each exercise safely and correctly. Participants will be contacted by study staff weekly over the phone to maintain interest and monitor adherence during the study.
OPTIONAL Referral to 12-week STEP-Home
Referral to the experimental 12-week STEP-Home workshop research study (VABHS IRB #3210).
OPTIONAL Clinical Referral
Clinical referrals to VABHS clinical services based on assessment and patient-directed primary problem/complaint.
Interventions
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V-TRACTS Assessment/Feedback
The proposed V-TRACTS assessment strategically targets emotional, cognitive and behavioral functions that we have determined are highly predictive of long-term outcome in Veterans. The assessment targets domains of head injury, psychological trauma, depression, suicidality, anxiety, chronic pain and sleep, substance use and activity level. This assessment will, in most cases, be completed online using the Qualtrics platform and online using telehealth or other approved platform for the clinical interview. Once the assessment is complete, the clinical team will convene a consensus meeting to review the case and determine a course of recommended additional assessment and/or rehabilitation action. After a consensus is reached, a V-TRACTS psychologist/supervised fellow will provide comprehensive feedback encompassing the entire assessment battery and offer rehabilitation options that would be targeted to the individual veteran's needs via VA telehealth or other approved online service.
OPTIONAL Brief Assessment of Thinking
A neuropsychological/cognitive assessment will be conducted to gather information about functioning in the areas of memory, attention, and thinking. This assessment is designed to be done online in a single session, and it will take approximately 45-90 minutes to complete. The test battery is designed to focus on the specific cognitive abilities thought to be impacted by blast, mTBI, PTSD, etc. This battery is not intended to be an exhaustive assessment of all neuropsychological functions.
OPTIONAL STEP-Home-Brief
STEP-Home-Brief is a condensed version of the 12-week experimental program STEP-Home that will target four core skills (problem solving, emotional regulation, attention training, and health and wellness). It will be individualized to Veterans' problems: vocation/career, community reintegration, psychoeducation to destigmatize barriers to mental health, substance misuse, anger management, and family and intimate partner relationships. STEP-Home-Brief will include 1-3 sessions using the same treatment modules as the 12-week program in a condensed, targeted format.
OPTIONAL At-home Exercise Program
This is a 5-week, full-body exercise program that can be done in the convenience of the Veteran's home, using only bodyweight as resistance and with household items as equipment. Given the online delivery of this program, they will receive access to instructional videos and materials that demonstrate how to perform each exercise safely and correctly. Participants will be contacted by study staff weekly over the phone to maintain interest and monitor adherence during the study.
OPTIONAL Referral to 12-week STEP-Home
Referral to the experimental 12-week STEP-Home workshop research study (VABHS IRB #3210).
OPTIONAL Clinical Referral
Clinical referrals to VABHS clinical services based on assessment and patient-directed primary problem/complaint.
Eligibility Criteria
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Inclusion Criteria
* English-speaking (sessions will be conducted in English)
* Agreeing to participate either remotely or in person (i.e., completion of ICF/HIPAA)
Exclusion Criteria
* Active suicidality
* Neurological diagnosis (excluding TBI)
18 Years
70 Years
ALL
Yes
Sponsors
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VA Boston Healthcare System
FED
Responsible Party
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Regina McGlinchey
Director, TRACTS
Principal Investigators
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Regina McGlinchey, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System
Locations
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VA Boston Healthcare System
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VABHS IRB#3326
Identifier Type: -
Identifier Source: org_study_id
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