Boston, Massachusetts 02130

  • PTSD

Purpose:

For this clinical demonstration study, Veterans will be assessed with a battery of questionnaires/surveys and a 1:1 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 Veteran's needs and also via VA telehealth or other approved online service. It will be the Veteran's choice whether he/she wants to participate in any one or more of these options.


Study summary:

V-TRACTS plans to assess up to 110 post-9/11 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 Veteran's risk for poor functional outcome and to determine his/her 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 neuropsychological/cognitive 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 Veteran's area(s) 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 Veteran's choice whether he/she wants to participate in any one or more of the cognitive assessment or rehabilitation options. These options are available sequentially or concurrently.


Criteria:

Inclusion Criteria: - Participants will be post-9/11 Veterans. Critically, formal diagnosis of TBI or PTSD (or any other cognitive/psychiatric condition) is not required. While inclusion criteria do not require any specific diagnosis, we note that TRACTS and STEP-Home Veterans in our previous studies had high rates of both PTSD and mTBI. - 18-70 years old - English-speaking (sessions will be conducted in English) - Agreeing to participate either remotely or in person (i.e., completion of ICF/HIPAA) Exclusion Criteria: - Schizophreniform disorder/active psychosis - Active suicidality - Neurological diagnosis (excluding TBI)


NCT ID:

NCT04723745


Primary Contact:

Principal Investigator
Regina McGlinchey, PhD
VA Boston Healthcare System

Regina McGlinchey, PhD
Phone: 857-248-0091
Email: regina.mcglinchey@va.gov


Backup Contact:

Email: dylan.katz@va.gov
Dylan Katz, MS
Phone: 857-364-4919


Location Contact:

Boston, Massachusetts 02130
United States

Regina McGlinchey, PhD
Phone: 857-248-0091
Email: regina.mcglinchey@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

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