Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04723745
Status:
RECRUITING
Last Update Posted:
2021-01-26
First Post:
2021-01-11
Brief Title:
Translational Research Center for TBI and Stress Disorders Virtual Assessment of Deployment Trauma and Rehabilitation
Sponsor:
VA Boston Healthcare System
Organization:
VA Boston Healthcare System
Study Overview
Official Title:
Translational Research Center for TBI and Stress Disorders Virtual Assessment of Deployment Trauma and Rehabilitation
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
V-TRACTS
Brief Summary:
For this clinical demonstration study Veterans will be assessed with a battery of questionnairessurveys and a 11 clinical interview with a V-TRACTS psychologist to target domains of head injury psychological trauma depression suicidality anxiety chronic pain and sleep substance use and activity level V-TRACTS will convene a weekly consensus meeting to evaluate all the data and develop a recommendation plan After the consensus meeting a V-TRACTS psychologist will provide comprehensive feedback encompassing the entire assessment battery Additionally if warranted the investigators will offer an optional cognitive assessment as well as rehabilitation options that the consensus committee targets the individual Veterans needs and also via VA telehealth or other approved online service It will be the Veterans choice whether heshe wants to participate in any one or more of these options
Detailed Description:
V-TRACTS plans to assess up to 110 post-911 Veterans This clinical demonstration project may be conducted primarily 1 using a VA telehealth or online delivery system to meet the needs of remote Veterans or those who are unable to attend sessions on campus as well as to maximize access to care during COVID-19 and thereafter or 2 in person at VA when possible and preferable to the Veteran The investigators will use a multidimensional but condensed version of the comprehensive TRACTS Core B VABHS IRB 2354 evaluation This condensed and efficient assessment will be used to develop a standard quantitative analytic to characterize each Veterans risk for poor functional outcome and to determine hisher rehabilitation needs For the intervention the investigators propose to offer various telehealth assessment and treatment options to each Veteran assessed or to refer on to VA clinical service as appropriate There are three research-based treatments and an additional brief cognitive assessment included in this protocol that may be offered at the feedback appointment First is a Brief Assessment of Thinking which is a neuropsychologicalcognitive assessment that will be conducted to gather information about functioning in the areas of memory attention and thinking if appropriate Second is STEP-Home-Brief which is an innovative integrated transdiagnostic rehabilitation workshop that targets each individual Veterans areas of weakness identified by the assessment if appropriate STEP-Home-Brief provides a patient-centered transdiagnostic treatment approach and can be delivered via telehealth or in-person STEP-Home-Brief also provides an introduction to a destigmatized mental health intervention that has been demonstrated to act as a gateway to further VA treatment engagement Third is an At-Home Exercise program if appropriate which will provide Veterans with an at-home 5-week program targeting cardiovascular health and endurance Fourth the investigators may offer referrals to the experimental 12-week STEP-Home workshop VABHS IRB 3210 Fifth the investigators may offer referrals to clinical programs as appropriate These referrals include but are not limited to Polytrauma Center for Returning Veterans Whole Health PTSD Mental Health Vocational Rehabilitation and Neurology The decision as to which type of treatment would best meet the needs of individual Veterans will be informed by a consensus of the V-TRACTS clinical team It will be the Veterans choice whether heshe wants to participate in any one or more of the cognitive assessment or rehabilitation options These options are available sequentially or concurrently
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None