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

NCT04723745 | Unknown

• 1 other identifier: VABHS IRB#3326
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TBI; PTSD/Stress Disorders; Iraq; Afghanistan

Outcome Measures

Primary Outcomes (4)

• Feasibility of a virtual deployment trauma assessment and feedback in post-9/11 Veterans: Willingness to Enroll

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

  Through study completion, 4-6 weeks from initial meeting

• Feasibility of a virtual deployment trauma assessment and feedback in post-9/11 Veterans: Actual Enrollment

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

  Through study completion, 4-6 weeks from initial meeting

• Feasibility of a virtual deployment trauma assessment and feedback in post-9/11 Veterans: Interest in Workshop Goals

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

  Through study completion, 4-6 weeks from initial meeting

• Acceptability of a virtual deployment trauma assessment and feedback in post-9/11 Veterans

  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.

  Through study completion, 4-6 weeks from initial meeting

Secondary Outcomes (2)

• Quality of Life Scale (QOLS)

  Through study completion, 4-6 weeks from initial meeting

• WHODAS-Brief

  Through study completion, 4-6 weeks from initial meeting

Study Arms (1)

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.

Behavioral: V-TRACTS Assessment/Feedback; Behavioral: OPTIONAL Brief Assessment of Thinking; Behavioral: OPTIONAL STEP-Home-Brief; Behavioral: OPTIONAL At-home Exercise Program; Behavioral: OPTIONAL Referral to 12-week STEP-Home; Behavioral: OPTIONAL Clinical Referral

Interventions

V-TRACTS Assessment/Feedback BEHAVIORAL

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.

VTRACTS

OPTIONAL Brief Assessment of Thinking BEHAVIORAL

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.

VTRACTS

OPTIONAL STEP-Home-Brief BEHAVIORAL

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.

VTRACTS

OPTIONAL At-home Exercise Program BEHAVIORAL

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.

VTRACTS

OPTIONAL Referral to 12-week STEP-Home BEHAVIORAL

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

VTRACTS

OPTIONAL Clinical Referral BEHAVIORAL

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

VTRACTS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 .

You may qualify if:

• years old
• English-speaking (sessions will be conducted in English)
• Agreeing to participate either remotely or in person (i.e., completion of ICF/HIPAA)

You may not qualify if:

• Schizophreniform disorder/active psychosis
• Active suicidality
• Neurological diagnosis (excluding TBI)

Sponsors & Collaborators

• VA Boston Healthcare System: lead

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

RECRUITING

Related Publications (62)

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MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Regina McGlinchey, PhD

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina McGlinchey, PhD

CONTACT

857-248-0091; regina.mcglinchey@va.gov

Dylan Katz, MS

CONTACT

857-364-4919; dylan.katz@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, TRACTS

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 26, 2021
• Study Start: December 8, 2020
• Primary Completion: December 7, 2024
• Study Completion: December 7, 2024
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When study personnel are no longer part of the research team, they will be removed from the IRB list of study staff and will not have access to data files.

Locations

US (1)