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.

Translational Research Center for TBI and Stress Disorders: Virtual Assessment of Deployment Trauma and Rehabilitation

TBI (Traumatic Brain Injury)

PTSD

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.

V-TRACTS Assessment/Feedback

OPTIONAL Brief Assessment of Thinking

OPTIONAL STEP-Home-Brief

OPTIONAL At-home Exercise Program

OPTIONAL Referral to 12-week STEP-Home

OPTIONAL Clinical Referral

Willingness to Enroll = ratio agreeing to be contacted (stating interest) out of those who were approached for the study

Actual Enrollment = ratio actually enrolled (consented) out of those who were approached for the study

Interest in Workshop Goals = average interest rating (as assessed by Likert rating scale)

Acceptability (tolerability/adherence) will be measured by visit attendance and completion/retention rates. Attrition vs. Completion Characteristics: Summary techniques will be used to compare the demographic and clinical characteristics of individuals who drop out compared to those who complete all visits. Descriptive characteristics of participants will be stratified by completion status with means and standard deviations presented for continuous variables and relative frequencies and percentages for categorical variables. Chi-square tests (for categorical variables) and t-tests (for continuous variables) will be used to evaluate demographic and clinical characteristics for significant predictors of treatment completion. Veterans' adherence will be assessed in terms of the number of visits attended. Attrition rates will also be determined.

Director, TRACTS

The 15-item QOLS, pioneered by Flanagan, has shown to be internally consistent (Cronbach's alpha, α: 0.82 to 0.92) and had high test-retest reliability (r=0.78 to r=0.84). Further research has reported similar reliability estimates for the 16-item scale.

The WHODAS has been shown to have high internal consistency (Cronbach's alpha, α: 0.86), stable factor structure, and high test-retest reliability (intraclass correlation coefficient: 0.98). In addition, the WHODAS was specifically developed to measure clinical outcomes and treatment effectiveness over time. It has established sensitivity to symptom change across a wide range of clinical conditions including depression and anxiety disorders, physical illness, and traumatic brain injury.

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.

Translational Research Center for TBI and Stress Disorders: Virtual Assessment of Deployment Trauma and Rehabilitation

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status