Baseline Participant Characteristics (Modified Intention-to-Treat Population)
head injury, traumatic brain injury, TEAEs, TBI, PTSD, depression, head trauma
ADVERSE EVENTS, SENSITIVITY, MAY, SECONDARY, ADVERSE EVENT, REGRESSION
Abbreviations: DSM-IV, Data are presented as number (percentage) of study participants unless otherwise indicated.Other includes individuals of multiple races.Participants were considered as having no TBI if they reported no head injury or improbable TBI per the Ohio State University TBI assessment form. Participants were classified as having TBI if they reported any degree of TBI following head trauma, ranging from possible to severe.As secondary analyses, 90% CIs for the difference in response rates were provided, and logistic regression models adjusting for baseline characteristics were developed. Sensitivity analyses for handling missing CAPS scores included complete case analysis, worst case scenario, and last available case carried forward.Additional analyses of the CAPS score trajectory over time using repeated-measures covariance-pattern models and allowing arbitrary patterns in the mean response and covariance structure were conducted.For all descriptive clinical outcomes, degrees of freedom were based on the Kenward-Roger method. Reported change values and 95% CIs are the least-squares estimates using the restricted maximum likelihood method for estimation. Functional impairment was analyzed using a mixed-effects proportional odds model with a random intercept. The primary outcome was also explored for subgroups defined by classification before randomization for PTSD severity, depression, lifetime traumatic brain injury (TBI) status, Miller Forensic Assessment of Symptoms Test scores, and psychotropic medication use.For cortisol and ACTH levels, medians and IQRs were reported for the baseline values and the change values (within group) from baseline. Hodges-Lehmann estimates of median difference and 95% CIs were reported for the change values (between-group comparisons). Treatment-emergent adverse events (TEAEs) reported by at least 4% of participants from either intervention group were compared. The numerator is the number of participants with the specified adverse event in each treatment arm. The denominator is the total number of participants within each arm in the safety analysis population. The Fisher exact test was used, except for the total number of TEAEs and number of TEAEs in the first week, for which the Pearson χAnalyses were conducted between August 2014 and May 2017. SAS/STAT, version 9.4 (SAS Institute Inc) was used for statistical analysis. Hypothesis tests were 2-sided with an α = .05.