PTSD Clinical Trial
— V-TRACTSOfficial title:
Translational Research Center for TBI and Stress Disorders: Virtual Assessment of Deployment Trauma and Rehabilitation
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
VA Boston Healthcare System |
United States,
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* Note: There are 62 references in all — Click here to view all references
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 |
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