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TBI (Traumatic Brain Injury)V-TRACTSNCT04723745

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

An observational study of TBI (Traumatic Brain Injury) and PTSD, run by VA Boston Healthcare System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
TBI (Traumatic Brain Injury), PTSD
What is being tested?
V-TRACTS Assessment/Feedback, OPTIONAL Brief Assessment of Thinking and OPTIONAL STEP-Home-Brief
How many people
100 participants
Where
1 siteUnited States
Study dates
8 Dec 2020to 7 Dec 2024
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 .

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Regina McGlinchey, PhD contact

857-248-0091

regina.mcglinchey@va.gov

Dylan Katz, MS contact

857-364-4919

dylan.katz@va.gov

United States1 site, 1 recruiting

  • VA Boston Healthcare System

    Boston, Massachusetts, 02130

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

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
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
Keywords
TBI, PTSD/Stress Disorders, Iraq, Afghanistan
Medical subject headings
Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V-TRACTS Assessment/FeedbackBehavioural

    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.

  • OPTIONAL Brief Assessment of ThinkingBehavioural

    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.

  • OPTIONAL STEP-Home-BriefBehavioural

    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.

  • OPTIONAL At-home Exercise ProgramBehavioural

    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.

  • OPTIONAL Referral to 12-week STEP-HomeBehavioural

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

  • OPTIONAL Clinical ReferralBehavioural

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

Study groups in NCT04723745
Study groupRoleWhat they receive
VTRACTSWe 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, 4-6 weeks from initial meeting

  2. 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

    Measured: Through study completion, 4-6 weeks from initial meeting

  3. 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)

    Measured: Through study completion, 4-6 weeks from initial meeting

  4. 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.

    Measured: Through study completion, 4-6 weeks from initial meeting

Secondary outcomes (2)

  1. Quality of Life Scale (QOLS)

    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.

    Measured: Through study completion, 4-6 weeks from initial meeting

  2. WHODAS-Brief

    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.

    Measured: Through study completion, 4-6 weeks from initial meeting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2021
  2. Study start8 Dec 2020
  3. Primary completion7 Dec 2024 (estimated)
  4. Study completion7 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04723745
Sponsor's protocol ID
VABHS IRB#3326
Acronym
V-TRACTS
Status last verified
Jan 2021
First submitted
11 Jan 2021
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Extracted from ICF for VABHS IRB #3326: "Studies under the approval of the VABHS Institutional Review Board who have received specific approval to use data from TRACTS, via the TRACTS data repository, may also have access, but only if you agree to share your data."

Publications

  • Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.

    PubMed 18234750

  • McGlinchey RE, Milberg WP, Fonda JR, Fortier CB. A methodology for assessing deployment trauma and its consequences in OEF/OIF/OND veterans: The TRACTS longitudinal prospective cohort study. Int J Methods Psychiatr Res. 2017 Sep;26(3):e1556. doi: 10.1002/mpr.1556. Epub 2017 Feb 17.

    PubMed 28211592

  • Evans DL, Charney DS, Lewis L, Golden RN, Gorman JM, Krishnan KR, Nemeroff CB, Bremner JD, Carney RM, Coyne JC, Delong MR, Frasure-Smith N, Glassman AH, Gold PW, Grant I, Gwyther L, Ironson G, Johnson RL, Kanner AM, Katon WJ, Kaufmann PG, Keefe FJ, Ketter T, Laughren TP, Leserman J, Lyketsos CG, McDonald WM, McEwen BS, Miller AH, Musselman D, O'Connor C, Petitto JM, Pollock BG, Robinson RG, Roose SP, Rowland J, Sheline Y, Sheps DS, Simon G, Spiegel D, Stunkard A, Sunderland T, Tibbits P Jr, Valvo WJ. Mood disorders in the medically ill: scientific review and recommendations. Biol Psychiatry. 2005 Aug 1;58(3):175-89. doi: 10.1016/j.biopsych.2005.05.001.

    PubMed 16084838

  • Sayer NA, Orazem RJ, Noorbaloochi S, Gravely A, Frazier P, Carlson KF, Schnurr PP, Oleson H. Iraq and Afghanistan War Veterans with Reintegration Problems: Differences by Veterans Affairs Healthcare User Status. Adm Policy Ment Health. 2015 Jul;42(4):493-503. doi: 10.1007/s10488-014-0564-2.

    PubMed 24913102

  • Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.

    PubMed 15229303

  • Fortier CB, Kenna A, Dams-O'Connor K, Fonda J, Levin LK, Hursh C, Franz H, Milberg WP, McGlinchey RE. Feasibility of a Skills-Based Group Reintegration Workshop for OEF/OIF Veterans: STEP-Home. J Head Trauma Rehabil. 2018 Jul/Aug;33(4):E17-E23. doi: 10.1097/HTR.0000000000000362.

    PubMed 29194181

  • Goetter EM, Bui E, Ojserkis RA, Zakarian RJ, Brendel RW, Simon NM. A Systematic Review of Dropout From Psychotherapy for Posttraumatic Stress Disorder Among Iraq and Afghanistan Combat Veterans. J Trauma Stress. 2015 Oct;28(5):401-9. doi: 10.1002/jts.22038. Epub 2015 Sep 16.

    PubMed 26375387

  • Fortier CB, Amick MM, Grande L, McGlynn S, Kenna A, Morra L, Clark A, Milberg WP, McGlinchey RE. The Boston Assessment of Traumatic Brain Injury-Lifetime (BAT-L) semistructured interview: evidence of research utility and validity. J Head Trauma Rehabil. 2014 Jan-Feb;29(1):89-98. doi: 10.1097/HTR.0b013e3182865859.

    PubMed 23535389

  • Fortier CB, Amick MM, Kenna A, Milberg WP, McGlinchey RE. Correspondence of the Boston Assessment of Traumatic Brain Injury-Lifetime (BAT-L) clinical interview and the VA TBI screen. J Head Trauma Rehabil. 2015 Jan-Feb;30(1):E1-7. doi: 10.1097/HTR.0000000000000008.

    PubMed 24336147

  • Soble JR, Silva MA, Vanderploeg RD, Curtiss G, Belanger HG, Donnell AJ, Scott SG. Normative Data for the Neurobehavioral Symptom Inventory (NSI) and post-concussion symptom profiles among TBI, PTSD, and nonclinical samples. Clin Neuropsychol. 2014;28(4):614-32. doi: 10.1080/13854046.2014.894576. Epub 2014 Mar 14.

    PubMed 24625213

  • Yardley L, Masson E, Verschuur C, Haacke N, Luxon L. Symptoms, anxiety and handicap in dizzy patients: development of the vertigo symptom scale. J Psychosom Res. 1992 Dec;36(8):731-41. doi: 10.1016/0022-3999(92)90131-k.

    PubMed 1432863

  • Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.

    PubMed 8630207

  • Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The Life Events Checklist for DSM-5 (LEC-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov

  • Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

    PubMed 28493729

  • Beck, A.T., R.A. Steer, and G.T. Brown, Beck Depression Inventory-II. 1996.

Questions about this trial

What is this clinical trial studying?

An observational study of TBI (Traumatic Brain Injury) and PTSD, run by VA Boston Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Regina McGlinchey, PhD (857-248-0091, regina.mcglinchey@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of a virtual deployment trauma assessment and feedback in post-9/11 Veterans: Willingness to Enroll (time frame: Through study completion, 4-6 weeks from initial meeting). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04723745, which also lists 62 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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