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

PTSD Clinical Trial

— V-TRACTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723745
• Other study ID #: VABHS IRB#3326
• Status: Recruiting
• Start date: December 8, 2020
• Est. completion date: December 7, 2024

Study information

• Verified date: January 2021
• Source: VA Boston Healthcare System
• Contact: Regina McGlinchey, PhD
• Phone: 857-248-0091
• Email: regina.mcglinchey[@]va.gov
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 7, 2024
• Est. primary completion date: December 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• PTSD
• Stress Disorders, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

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.
• 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.
• 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.
• 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.
• OPTIONAL Referral to 12-week STEP-Home
Referral to the experimental 12-week STEP-Home workshop research study (VABHS IRB #3210).
• OPTIONAL Clinical Referral
Clinical referrals to VABHS clinical services based on assessment and patient-directed primary problem/complaint.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Quality of Life Scale (QOLS)	The 15-item QOLS, pioneered by Flanagan, has shown to be internally consistent (Cronbach's alpha, a: 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.	Through study completion, 4-6 weeks from initial meeting
Secondary	WHODAS-Brief	The WHODAS has been shown to have high internal consistency (Cronbach's alpha, a: 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.	Through study completion, 4-6 weeks from initial meeting