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

NCT04723745 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-01-26

No results posted yet for this study

Summary

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.

Conditions

  • TBI (Traumatic Brain Injury)
  • PTSD

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

OPTIONAL Referral to 12-week STEP-Home

Referral to the experimental 12-week STEP-Home workshop research study (VABHS IRB #3210).

BEHAVIORAL

OPTIONAL Clinical Referral

Clinical referrals to VABHS clinical services based on assessment and patient-directed primary problem/complaint.

Sponsors & Collaborators

  • VA Boston Healthcare System

    lead FED

Principal Investigators

  • Regina McGlinchey, PhD · VA Boston Healthcare System

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2024-12-07
Completion
2024-12-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04723745 on ClinicalTrials.gov