Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial.

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 Participants: This 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). Results: Of 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 Relevance: In 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.

Centrally Assisted Collaborative Telecare for Posttraumatic Stress Disorder and Depression Among Military Personnel Attending Primary Care: A Randomized Clinical Trial.

IMPORTANCE: It is often difficult for members of the US military to access high-quality care for posttraumatic stress disorder (PTSD) and depression. OBJECTIVE: To determine effectiveness of a centrally assisted collaborative telecare (CACT) intervention for PTSD and depression in military primary care. DESIGN, SETTING, AND PARTICIPANTS: The STEPS-UP study (Stepped Enhancement of PTSD Services Using Primary Care) is a randomized trial comparing CACT with usual integrated mental health care for PTSD or depression. Patients, mostly men in their 20s, were enrolled from 18 primary care clinics at 6 military installations from February 2012 to August 2013 with 12-month follow-up completed in October 2014. INTERVENTIONS: Randomization was to CACT (n = 332) or usual care (n = 334). The CACT patients received 12 months of stepped psychosocial and pharmacologic treatment with nurse telecare management of caseloads, symptoms, and treatment. MAIN OUTCOMES AND MEASURES: Primary outcomes were severity scores on the PTSD Diagnostic Scale (PDS; scored 0-51) and Symptom Checklist depression items (SCL-20; scored 0-4). Secondary outcomes were somatic symptoms, pain severity, health-related function, and mental health service use. RESULTS: Of 666 patients, 81% were male and the mean (SD) age was 31.1 (7.7) years. The CACT and usual care patients had similar baseline mean (SD) PDS PTSD (29.4 [9.4] vs 28.9 [8.9]) and SCL-20 depression (2.1 [0.6] vs 2.0 [0.7]) scores. Compared with usual care, CACT patients reported significantly greater mean (SE) 12-month decrease in PDS PTSD scores (-6.07 [0.68] vs -3.54 [0.72]) and SCL-20 depression scores -0.56 [0.05] vs -0.31 [0.05]). In the CACT group, significantly more participants had 50% improvement at 12 months compared with usual care for both PTSD (73 [25%] vs 49 [17%]; relative risk, 1.6 [95% CI, 1.1-2.4]) and depression (86 [30%] vs 59 [21%]; relative risk, 1.7 [95% CI, 1.1-2.4]), with a number needed to treat for a 50% improvement of 12.5 (95% CI, 6.9-71.9) and 11.1 (95% CI, 6.2-50.5), respectively. The CACT patients had significant improvements in somatic symptoms (difference between mean 12-month Patient Health Questionnaire 15 changes, -1.37 [95% CI, -2.26 to -0.47]) and mental health-related functioning (difference between mean 12-month Short Form-12 Mental Component Summary changes, 3.17 [95% CI, 0.91 to 5.42]), as well as increases in telephone health contacts and appropriate medication use. CONCLUSIONS AND RELEVANCE: Central assistance for collaborative telecare with stepped psychosocial management modestly improved outcomes of PTSD and depression among military personnel attending primary care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01492348.

Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system.

BACKGROUND: War-related trauma, posttraumatic stress disorder (PTSD), depression and suicide are common in US military members. Often, those affected do not seek treatment due to stigma and barriers to care. When care is sought, it often fails to meet quality standards. A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system. OBJECTIVE: The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care. METHODS: The STEPS-UP Trial (STepped Enhancement of PTSD Services Using Primary Care) is a 6 installation (18 clinic) randomized effectiveness trial in the US military health system. Study rationale, design, enrollment and sample characteristics are summarized. FINDINGS: Military members attending primary care with suspected PTSD, depression or both were referred to care management and recruited for the trial (2592), and 1041 gave permission to contact for research participation. Of those, 666 (64%) met eligibility criteria, completed baseline assessments, and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care. Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP. Research reassessments occurred at 3-, 6-, and 12-months. Baseline characteristics were similar across the two intervention groups. CONCLUSIONS: STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system, assessing how an implementation model affects collaborative care impact on mental health outcomes. It promises lessons for health system change.

Alcohol use after forced abstinence in basic training among United States Navy and Air Force trainees.

OBJECTIVE: The present study examined drinking rates of U.S. Navy and Air Force trainees during the month before attending basic training and after the ban on drinking alcohol was lifted during advanced training. METHOD: Surveys were obtained at five training bases (one U.S. Navy, four U.S. Air Force) from 6,298 persons for a response rate of 65%. Analyses were based on 4,962 young adults ages 18-25 (82% male) who gave valid responses about pre-basic drinking. RESULTS: Findings showed a rate of 43.1% heavy episodic drinking during the month before basic training, 15.8% by infrequent heavy episodic drinkers (five or more drinks per occasion at least once, four or more for women), and 27.3% by frequent heavy episodic drinkers (five or more drinks per occasion, four or more for women, at least once a week). Pre-basic frequent heavy episodic drinkers averaged 7.9 drinks per occasion and nearly 15 heavy episodic drinking days during the month. In contrast, heavy episodic drinking following basic training was substantially lower: 12.0% for infrequent heavy episodic drinkers and 9.0% for frequent heavy episodic drinkers. Comparisons with the U.S. Department of Defense Health Related Behaviors Survey suggest that post-basic frequent heavy episodic drinking rates are likely to increase over time but not to pre-basic levels. Pre-basic infrequent and frequent heavy episodic drinkers were more likely than nondrinkers or non-heavy episodic drinkers to initiate or re-initiate frequent heavy episodic drinking. Frequent heavy episodic drinking after basic tended to occur 1-6 weeks after the ban on alcohol use was lifted. CONCLUSIONS: Selection and socialization help explain heavy episodic drinking of U.S Navy and U.S. Air Force trainees.

Measurement invariance of alcohol use motivations in junior military personnel at risk for depression or anxiety.

Measurement invariance is typically assumed when assessing drinking-related constructs across distinct groups of respondents. However, measurement properties of motivations related to mood maintenance and stress relief may differ in those experiencing symptoms of depression or anxiety. Invariance of social and coping drinking motives were explored with a sample of 4133 junior enlisted Air Force and Navy personnel. Measurement did not differ in those with depression symptoms. In contrast, those with anxiety symptoms differed in measurement of both motives. The impact of non-equivalence was demonstrated with a mediation model in which anxiety and depression predicted drinking motives, which in turn predicted heavy drinking. Incorporation of the partial invariance of the social motives factor attenuated the estimate of the mediated effect of social drinking motives by almost half compared to the estimate with invariance assumed. These results suggest that lack of measurement invariance could seriously bias or alter conclusions from tests of theoretical models and highlight the need for researchers to carefully consider the measurement properties of their constructs prior to model estimation.