Michael C. Freed

Common Data Elements for Posttraumatic Stress Disorder Research

An expert work group with 7 members was formed under the cosponsorship of 5 U.S. federal agencies to identify common data elements for research related to posttraumatic stress disorder (PTSD). The work group reviewed both previous and contemporary measurement standardization efforts for PTSD research and engaged in a series of electronic and live discussions to address a set of predefined aims. Eight construct domains relevant to PTSD were identified: (1) traditional demographics, (2) exposure to stressors and trauma, (3) potential stress moderators, (4) trauma assessment, (5) PTSD screening, (6) PTSD symptoms and diagnosis, (7) PTSD-related functioning and disability, and (8) mental health history. Measures assigned to the core data elements category have relatively low time-and-effort costs in order to make them potentially applicable across a wide range of studies for which PTSD is a relevant condition. Measures assigned to the supplemental data elements category have greater costs but generally demonstrate stronger psychometric performance and provide more extensive information. Accordingly, measures designated as supplemental are recommended instead of or in addition to corresponding core measures whenever resources and study design allow. The work group offered 4 caveats that highlight potential limitations and emphasize the voluntary nature of standardization for PTSD-related measurement.

Randomized Effectiveness Trial of a Brief Course of Acupuncture for Posttraumatic Stress Disorder

Background:Initial posttraumatic stress disorder (PTSD) care is often delayed and many with PTSD go untreated. Acupuncture appears to be a safe, potentially nonstigmatizing treatment that reduces symptoms of anxiety, depression, and chronic pain, but little is known about its effect on PTSD. Methods:Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care (UPC) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone. Outcomes were assessed at baseline and 4, 8, and 12 weeks postrandomization. The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist (PCL) and the Clinician-administered PTSD Scale (CAPS) from baseline to 12-week follow-up between the 2 treatment groups. Secondary outcomes were depression, pain severity, and mental and physical health functioning. Mixed model regression and t test analyses were applied to the data. Results:Mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC (PCL&Dgr;=19.8±13.3 vs. 9.7±12.9, P<0.001; CAPS&Dgr;=35.0±20.26 vs. 10.9±20.8, P<0.0001). Acupuncture was also associated with significantly greater improvements in depression, pain, and physical and mental health functioning. Pre-post effect-sizes for these outcomes were large and robust. Conclusions:Acupuncture was effective for reducing PTSD symptoms. Limitations included small sample size and inability to parse specific treatment mechanisms. Larger multisite trials with longer follow-up, comparisons to standard PTSD treatments, and assessments of treatment acceptability are needed. Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment.

IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.

Mental Health Utilization Patterns During a Stepped, Collaborative Care Effectiveness Trial for PTSD and Depression in the Military Health System

Background:Integrated health care models aim to improve access and continuity of mental health services in general medical settings. STEPS-UP is a stepped, centrally assisted collaborative care model designed to improve posttraumatic stress disorder (PTSD) and depression care by providing the appropriate intensity and type of care based on patient characteristics and clinical complexity. STEPS-UP demonstrated improved PTSD and depression outcomes in a large effectiveness trial conducted in the Military Health System. The objective of this study was to examine differences in mental health utilization patterns between patients in the stepped, centrally assisted collaborative care model relative to patients in the collaborative care as usual-treatment arm. Methods:Patients with probable PTSD and/or depression were recruited at 6 large military treatment facilities, and 666 patients were enrolled and randomized to STEPS-UP or usual collaborative care. Utilization data acquired from Military Health System administrative datasets were analyzed to determine mental health service use and patterns. Clinical complexity and patient characteristics were based on self-report questionnaires collected at baseline. Results:Compared with the treatment as usual arm, STEPS-UP participants received significantly more mental health services and psychiatric medications across primary and specialty care settings during the year of their participation. Patterns of service use indicated that greater clinical complexity was associated with increased service use in the STEPS-UP group, but not in the usual-care group. Conclusions:Results suggest that stepped, centrally assisted collaborative care models may increase the quantity of mental health services patients receive, while efficiently matching care on the basis of the clinical complexity of patients.

Acceptability of Adverse Childhood Experiences Questions for Health Surveillance in U.S. Armed Forces

BACKGROUND Research has documented a consistent and strong association between adverse childhood experiences (ACE) and negative health outcomes in adulthood. The Department of Defense is expanding health surveillance of military members and considering the inclusion of ACE questions. OBJECTIVE To explore the perceptions and attitudes of service members and spouses regarding the use of ACE questions in routine health surveillance. METHOD Forty-one active duty service members and spouses were interviewed at two Army troop medical centers. Semistructured qualitative interviews were used to examine their views regarding the use of ACE questions in military health surveillance. RESULTS Participants believe there is value in health surveillance; however, they are cautious about providing ACE or other information that may be perceived negatively, without confidentiality reassurances. CONCLUSION Successful employment of ACE questions in active duty military health surveillance will depend on the ability of military health officials to ensure confidentiality and to communicate the relevance of ACE to health status.

Population Impact of PTSD and Depression Care for Military Service Members: Reach and Effectiveness of an Enhanced Collaborative Care Intervention

Objective: Epidemiologic studies suggest high rates of posttraumatic stress disorder (PTSD) and depression among military members and veterans. To meet the needs of this population, evidence-based treatments are recommended as first-line interventions, based on their clinical efficacy and not the proportion of the target population that the intervention reaches. We apply a public health framework to examine the population impact of an enhanced collaborative care model on a targeted population that takes into account effectiveness and reach.Methods: Using data collected from a 2012 - 2016 randomized trial, the effectiveness of enhanced collaborative care for PTSD and depression was evaluated using probable diagnostic status as the primary outcome. Exclusion criteria were then applied to a 2011 disease registry to examine the representativeness of the trial sample and estimate the potential reach of the intervention. Population impact was derived from the estimated effectiveness and reach of the intervention.Results: Enhanced collaborative care was associated with a significantly greater probability of PTSD/depression remission by the end of the trial (conditional effect = -0.066, chisq = 51.1, p < 0.001). Based on the effectiveness and reach of the enhanced intervention, an estimated 250 (out of the 3,436) more Army soldiers with PTSD and/or depression would experience diagnostic remission during the preceding year if the enhanced model was available.Conclusion: The population framework permits the estimated differential impact of two collaborative care models to inform implementation considerations. These results highlight the value of applying public health models to identify front line treatments.

Mental Health Services Research in the Military Health System.

elevated, this binding would artifactually inflate the plasma input function, giving spuriously low VTs. In line with this, we see a group difference in the plasma input function (Figure 1; F53.23, df545, 2, p,0.05).Thus,VTs are likely tobeunreliable on both counts. In contrast, distribution volume ratio is not affected by these problems, indicating that distribution volume ratio is to be preferred over VT. Distribution volume ratio has beenvalidated inanimals,where inflammatory stimuli increase distribution volume ratio and microglial markers (4). (For a further discussion of these issues, see [2].) The second issue raised is the choice of normalization region. The ideal region would be equivalent to gray matter tissue. However, for total gray matter, there is no other gray matter for reference. Identifying an ideal reference region is a challenge to the TSPO positron emission tomography field in general, particularly where microglial activation may be widespread.We fully agree thatdifferences in tissue fractions complicate interpretation of our results, as discussed in the article.We conducted sensitivity analyses to determine if the results were driven by white matter differences. If this were the case, we would expect a scaling of distribution volume ratio when normalizing to white matter, but this was not the case (see Table S7 in the data supplement accompanying the online version of the original article). We found that the elevation in distribution volume ratio in frontal and temporal regions was robust using different reference regions (see Table S7). These additional analyses indicate our results are unlikely to be driven by differences in the reference regions, although future studies are needed to test this further. Further issues raised are the large standard deviations and similargroupmeansinthesupplementarydata(seeTableS6and Figure S3 in the online data supplement). These supplementary dataarenot corrected forTSPOgenotypeorage. It is recognized that there is an approximate 50%difference between carriers of high binding variants over heterozygotes, which is also seen in postmortem studies of schizophrenia (5) and explains the large standard variations. Age and genotypewere corrected for in the primary analyses. It is clear that further work is warranted to understand the TSPO signal and the role of microglia in schizophrenia. We hope that Narendran and colleagues will join us in this enterprise.