IMPORTANCE This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms.OBJECTIVE To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks. DESIGN, SETTING, AND PARTICIPANTSThis multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months.INTERVENTIONS Paired right-sided SGB or sham procedures at weeks 0 and 2.MAIN OUTCOMES AND MEASURES Improvement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori). RESULTSOf 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was −12.6 points (95% CI, −15.5 to −9.7 points) for the group receiving SGB treatments, compared with −6.1 points (95% CI, −9.8 to −2.3 points) for those receiving sham treatment (P = .01). CONCLUSIONS AND RELEVANCEIn this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct.TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT03077919

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We examined the longitudinal course of primary care patients in the active duty Army with posttraumatic stress disorder (PTSD) and identified prognostic indicators of PTSD severity. Data were drawn from a 6-site randomized trial of collaborative primary care for PTSD and dpression in the military. Subjects were 474 soldiers with PTSD (scores ≥ 50 on the PTSD Checklist -Civilian Version). Four assessments were completed at U.S. Army installations: baseline, and follow-ups at 3 months (92.8% response rate [RR]), 6 months (90.1% RR), and 12 months (87.1% RR). Combat exposure and 7 validated indicators of baseline clinical status (alcohol misuse, depression, pain, somatic symptoms, low mental health functioning, low physical health functioning, mild traumatic brain injury) were used to predict PTSD symptom severity on the Posttraumatic Diagnostic Scale (Cronbach's α = .87, .92, .95, .95, at assessments 1-4, respectively). Growth mixture modeling identified 2 PTSD symptom trajectories: subjects reporting persistent symptoms (Persisters, 81.9%, n = 388), and subjects reporting improved symptoms (Improvers 18.1%, n = 86). Logistic regression modeling examined baseline predictors of symptom trajectories, adjusting for demographics, installation, and treatment condition. Subjects who reported moderate combat exposure, adjusted odds ratio (OR) = 0.44, 95% CI [0.20, 0.98], or who reported high exposure, OR = 0.39, 95% CI [0.17, 0.87], were less likely to be Improvers. Other baseline clinical problems were not related to symptom trajectories. Findings suggested that most military primary care patients with PTSD experience persistent symptoms, highlighting the importance of improving the effectiveness of their care. Most indicators of clinical status offered little prognostic information beyond the brief assessment of combat exposure.

BackgroundPsychological resilience is critical to minimize the health effects of traumatic events. Trauma may induce a chronic state of hyperarousal, resulting in problems such as anxiety, insomnia, or posttraumatic stress disorder. Mind-body practices, such as relaxation breathing and mindfulness meditation, help to reduce arousal and may reduce the likelihood of such psychological distress. To better understand resilience-building practices, we are conducting the Biofeedback-Assisted Resilience Training (BART) study to evaluate whether the practice of slow, paced breathing with or without heart rate variability biofeedback can be effectively learned via a smartphone app to enhance psychological resilience.ObjectiveOur objective was to conduct a limited, interim review of user interactions and study data on use of the BART resilience training app and demonstrate analyses of real-time sensor-streaming data.MethodsWe developed the BART app to provide paced breathing resilience training, with or without heart rate variability biofeedback, via a self-managed 6-week protocol. The app receives streaming data from a Bluetooth-linked heart rate sensor and displays heart rate variability biofeedback to indicate movement between calmer and stressful states. To evaluate the app, a population of military personnel, veterans, and civilian first responders used the app for 6 weeks of resilience training. We analyzed app usage and heart rate variability measures during rest, cognitive stress, and paced breathing. Currently released for the BART research study, the BART app is being used to collect self-reported survey and heart rate sensor data for comparative evaluation of paced breathing relaxation training with and without heart rate variability biofeedback.ResultsTo date, we have analyzed the results of 328 participants who began using the BART app for 6 weeks of stress relaxation training via a self-managed protocol. Of these, 207 (63.1%) followed the app-directed procedures and completed the training regimen. Our review of adherence to protocol and app-calculated heart rate variability measures indicated that the BART app acquired high-quality data for evaluating self-managed stress relaxation training programs.ConclusionsThe BART app acquired high-quality data for studying changes in psychophysiological stress according to mind-body activity states, including conditions of rest, cognitive stress, and slow, paced breathing.