Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions
NCT ID: NCT01502839
Last Updated: 2017-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
887 participants
OBSERVATIONAL
2011-03-31
2015-05-31
Brief Summary
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HYPOTHESES ARE AS FOLLOWS:
1. Individuals with a history of target, service-related, mTBI only (Group 2) and individuals with PTSD only (Group 3) each will report significantly more PC symptoms, as measured by NSI total scores, when compared to those with no history of service-related mTBI or PTSD (Group 4).
2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1) will report significantly more PC symptoms, as measured by total NSI scores, than either those with target, service-related, mTBI only (Group 2) or those with PTSD only (Group 3).
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Detailed Description
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Power is based on the primary hypothesis that those with PTSD only (Group 3) and those with target, service-related mTBI only (Group 2) will have significantly more PC symptom reporting than those with no history of target, service-related mTBI or PTSD (Group 4). Belanger et al. (2010) reported a standard deviation of 15.3 on the NSI total score in a sample of 134 mTBI subjects. Assuming variability similar to the Belanger study, a significance level of 0.025 to correct for the two comparisons and 80% power, 180 subjects per group will detect a clinically significant difference of 5 points. For simplicity, this was calculated using a two-sided, two-sample t-test. Given that we are modeling all four groups together, pooled standard error estimates will be used, which will result in slightly higher power.
All analyses will assume a two-sided test of hypothesis with an overall significance level of 0.05, unless otherwise noted, and will be performed in either Statistical Analysis Software (SAS) v9.2 or above (SAS Institute, Inc., Cary, NC).
Demographic characteristics will be reported as means and standard deviations; medians and ranges; and proportions, as appropriate. Likewise, characteristics will be compared between the four aforementioned subject groups using Analysis of Variance (ANOVA), chi-square tests and/or nonparametric tests as appropriate.
Hypothesis 1: An ANOVA with reference cell coding will be utilized to model NSI total score as a function of the four groups (Group 1: Individuals with co-occurring target, service-related, mTBI and PTSD; Group 2: those with target, service-related, mTBI only; Group 3: those with PTSD only; and Group 4: those with no history of target, service-related, mTBI or PTSD). Potential confounders will then be assessed individually by adding them to the model with the groups. If any of the group parameter estimates changes by more than 10% with the inclusion of the potential confounder, the variable will be utilized in the final model. Once the final model is determined, a contrast will be set up within the model to test (1) PTSD only vs. Neither and (2) target, service-related, mTBI only vs. Neither, a Bonferroni correction will be employed such that the significance level will be adjusted to 0.025 for these two primary tests. Estimated mean differences will be reported with 95% CIs. Potential confounding variables to be considered are: age; gender; total number of deployments; time since last deployment; time since earliest documented mTBI; time since target, service-related, mTBI; and total number of mTBIs.
Hypothesis 2: Within the same final model above, a contrast will be used to test (1) those with co-occurring target, service-related, mTBI and PTSD vs. PTSD only and (2) those with co-occurring target, service-related, mTBI and PTSD vs. target, service-related, mTBI only.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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OEF/OIF Veterans
Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans
No Intervention
This retrospective data analysis will rely on data obtained from chart review.
Interventions
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No Intervention
This retrospective data analysis will rely on data obtained from chart review.
Eligibility Criteria
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Inclusion Criteria
* Veteran must have at least one OEF/OIF deployment
* Veteran must have received an OEF/OIF TBI 2nd Level Evaluation though the VA ECHCS TBI Clinic
Group 1: (Both) Co-Occurring PTSD and target, service-related, mTBI
PTSD:
* Clinician confirmed PTSD diagnosis and continuous documentation of symptoms related to PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
* Clinician confirmed PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
* Clinician confirmed PTSD diagnosis within 60 days after being seen in TBI Clinic
* Target, service-related, mTBI
* Veterans with clinician confirmed target, service-related, mTBI per OEF/OIF TBI 2nd Level Evaluation Consult Report note in EMR
Group 2: (mTBI only) History of target, service-related, mTBI but with no diagnosis of PTSD
* PTSD:
* Veterans with no history of clinician confirmed PTSD diagnosis, or
* Veterans with previous clinician confirmed PTSD diagnosis , but without continuous documentation of PTSD symptoms within 1 year prior to being seen in the TBI clinic
* Target, service-related, mTBI
* Veterans with clinician confirmed target, service-related, mTBI per OEF/OIF TBI 2nd Level Evaluation Consult Report note in EMR
Group 3: (PTSD only) No history of target, service-related, mTBI but with a diagnosis of PTSD
* PTSD:
* Clinician confirmed PTSD diagnosis and continuous documentation of symptoms related to PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
* Clinician confirmed PTSD diagnosis within 1 year prior to being seen in the TBI Clinic, or
* Clinician confirmed PTSD diagnosis within 60 days of being seen in TBI Clinic
* TBI:
* Veterans with no history of clinician confirmed diagnosis of target, service-related, mTBI
* Veterans with clinician confirmed mTBI prior to service and without continuous documentation of related symptoms within 1 year of being seen in the TBI Clinic
Group 4: (Neither) No history of target, service-related, mTBI and no diagnosis of PTSD
* PTSD:
* Veterans with no history of clinician confirmed PTSD diagnosis, or
* Veterans with previous clinician confirmed PTSD diagnosis , but without continuous documentation of PTSD symptoms within 1 year of being seen in the TBI clinic
* TBI:
* Veterans with no clinician confirmed diagnosis of target, service-related, mTBI
* Veterans with any history of clinician confirmed moderate or severe TBI, and
* Veterans with no NSI in TBI Consult Report note in EMR
* Veterans with documentation of any neurological event or disorder other than mTBI
* Veterans with positive brain imaging
18 Years
60 Years
ALL
No
Sponsors
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VA Eastern Colorado Health Care System
FED
Responsible Party
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Principal Investigators
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Gina Signoracci, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VA Eastern Colorado Health Care System
Locations
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VA Eastern Colorado Health Care System
Denver, Colorado, United States
Countries
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Other Identifiers
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11-0219
Identifier Type: -
Identifier Source: org_study_id
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