VOLUME 173

MAY 2008

NUMBER 5

ORIGINAL ARTICLES

Authors alone are responsible for opinions expressed in the contribution and for its clearance through their federal health agency, if required.

MILITARY MEDICINE, 173, 5:411, 2008

Structured Clinical Interview Guide for Postdeployment Psychological Screening Programs Kathleen M. Wright, PhD; Amy B. Adler, PhD; LTC Paul D. Bliese, MS USA; Rachel D. Eckford, MA ABSTRACT Brief structured clinical interviews are a key component of the Department of Defense postdeployment health reassessment program. Such interviews are critical for recommending individuals for follow-up assessment and care. To standardize the interview process, U.S. Army Medical Research Unit-Europe developed a structured interview guide, designed in response to both clinical requirements and research findings. The guide includes sections on depression, suicidality, post-traumatic stress disorder, anger, relationship problems, alcohol problems, and sleep problems. In addition, there is an open-ended section on other problems and a section for case dispositions. Data from a 2005 blinded validation study with soldiers returning from a 1-year-long combat deployment are included to demonstrate the utility of the structured interview. Guidelines and implementation considerations for the use of the structured interview are discussed.

INTRODUCTION Psychological screening can provide military mental health professionals with an effective method of assessing the mental health needs of military personnel recently returned from deployment.1–5 Although there have been several screening programs, U.S. deployments to Iraq and Afghanistan prompted a required postdeployment health assessment (PDHA) at reintegration and a postdeployment health reassessment (PDHRA) 3 to 6 months after deployment.6 – 8 The development of the PDHRA program was mandated by the finding that reports of mental health problems increased from reintegration to 4 months after deployment.9 Both the PDHA and the PDHRA include items assessing physical symptoms and deployment exposures, in addition to psychological symptoms. Much of the content on psychological symptoms addressed in the PDHRA is based, in part, on the postdeployU.S. Army Medical Research Unit-Europe, Walter Reed Army Institute of Research, Heidelberg, Germany. The views expressed in this article are those of the authors and do not necessarily represent the official policy or position of the U.S. Army Medical Command or the Department of Defense. This manuscript was received for review in June 2007. The revised manuscript was accepted for publication in February 2008.

ment psychological screening program designed by the U.S. Army Medical Research Unit-Europe (USAMRU-E) and implemented throughout the U.S. Army in Europe.10,11 The systematic program of psychological screening research has focused on validating the screening measures, determining optimal items and cutoff values for the clinical dimensions, evaluating the program, and developing interview guidelines to accompany the PDHRA. This article details the interview questions recommended for the assessment of psychological symptoms as part of the PDHRA program. The PDHRA program uses Department of Defense (DD) Form 2900.7 This electronic form includes mental healthrelated questions that service members can endorse as part of the postdeployment process of identifying mental health concerns. After completion of the form, health care providers are expected to conduct an interview to determine the need for referral. There is a page on the form for providers to record the results of the interview. This article presents a structured interview guide that can be used as part of the provider interview portion of DD Form 2900. The guide was created in response to requests from health care providers for additional advice on how to assess mental health-related issues during the high-volume period that characterizes many PDHRA implementation plans. The

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guide has also been used in a series of screening validation studies conducted by the USAMRU-E with soldiers recently returned from combat operations in Iraq. The interview task is important for two reasons. First, the provider is responsible for identifying individuals in need of follow-up care. Second, the provider has the opportunity to be one of the first professionals with whom the service member may discuss problems. Through effective establishment of rapport, even a short interview has the potential to send a positive message about the individual’s likelihood of adjusting well during the postdeployment phase and to reduce the stigma associated with seeking mental health care. Therefore, the initial contact a service member has with a clinical provider not only may facilitate access to care but also may affect decisions to seek treatment. METHODS The structured clinical interview presented here reflects recommendations for clinical practice based on results from the use of the interview guide with soldiers in a blinded validation study conducted in 2005.10 For the validation study, a standard clinical method was required to assess the validity of the clinical dimensions of the psychological screening instrument that was the prototype for the mental health sections of DD Form 2900. The results of the validation research were reported by Bliese et al.10 and Wright et al.12 However, the purpose of this article is to describe how the structured clinical interview guide can be used in conjunction with the administration of DD Form 2900. The interview guide was developed by the USAMRU-E,13 is based on the Mini International Neuropsychiatric Interview (MINI)14 (a validated structured interview) and the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV),15 and assesses the same clinical dimensions as those covered in the validation research for DD Form 2900. Before we describe each module of the interview guide and how the guide performed during one of the validation studies, several key principles that influenced the development of the guide should be mentioned. Areas of Clinical Relevance versus Clinical Diagnoses Traditionally, structured clinical interviews address the complete list of diagnostic categories that appear in DSM-IV.15 On the basis of content validation studies with military personnel and the domains addressed in DD Form 2900, we selected a targeted number of clinical areas for inclusion in the structured interview guide.16 We also included areas that may not have direct counterparts in terms of DSM-IV diagnostic criteria but nevertheless are relevant for military populations. These areas include anger, relationship, and sleep problems and are considered to be global symptom areas that should be assessed in some capacity by health care providers interviewing service members after deployment. Similarly, a balance is needed between developing interview questions

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that match every possible clinical diagnostic category and developing questions that serve as a guide for clinical decision-making. In the interview guide presented here, we include a range of relevant questions about particular clinical dimensions, rather than relying exclusively on stringent criteria to make a specific diagnosis. The goal is to identify individuals in need of follow-up assessment, rather than performing a comprehensive review of each diagnostic category. Triage versus Intake Any structured interview should be designed to triage large numbers of military personnel in a short amount of time, targeting the most common symptom areas and assessing them quickly and efficiently. Although excellent structured diagnostic interview schedules are available,17,18 these comprehensive methods are time-consuming and not well suited for the needs of this particular screening task. In contrast, the interview guide described here was developed to be relatively short, with few complicated algorithms regarding question flow. The result is a series of questions that can identify individuals in need of follow-up care and more formal assessment. Semistructured versus Structured Interview When used for research purposes, the interview guide was followed verbatim; the results presented in this article are based on verbatim use of the guide. In an applied clinical setting, however, the interview is probably best regarded as a semistructured format. Interviewers may want to ask additional follow-up questions or to clarify information. These additional questions may address coping resources, social support, and symptom intensity, so that the clinician can gain a better understanding of the seriousness of the problems being described. In both clinical and research settings, conducting an interview requires developing rapport. This can be a challenge when there are hundreds of service members waiting their turn to be interviewed and there is pressure to complete each interview quickly. In our experience, the guide itself takes ⬍10 minutes to complete for individuals without problems and ⬃15 to 20 minutes for individuals with problems. Each interview module is reviewed below in terms of the relevant questions and how they relate to DD Form 2900. The complete interview guide is provided in Figure 1, Figure 2 illustrates how the interview guide may be used to supplement the PDHRA process. Interview Modules Depression

As Hoge et al.19 found, depression is one of the concerns most commonly reported by service members following their return from combat. DD Form 2900 uses two items to assess depression. These items are the first two stem depression questions from the Patient Health Questionnaire for Depres-

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Clinical Interview Guide

FIGURE 1. Postdeployment psychological screening structured interview guide. The shaded areas of the interview guide are instructions to the clinical interviewer and should not be read to the service member.

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FIGURE 1.

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Continued.

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Clinical Interview Guide

FIGURE 1.

Continued.

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Flowchart of the PDHRA process.33 ⴱ, Includes reserve component and Department of Defense civilians as well as active duty service

FIGURE 2. members.

sion20 and are considered above the cutoff value if either of the two items is endorsed with “more than half the days” or “nearly every day.”10 The structured interview module for depression primarily assesses symptoms of major depressive disorder and is adapted directly from the MINI.14 (Although the MINI is copyrighted, a note on the front of the manual states that researchers and clinicians working in nonprofit organizations may use the MINI for clinical and research purposes.) There are a total of nine symptom questions and two additional background questions that ask about functional impairment and lifetime history. In the original MINI, endorsement of at least one of the first two stem depression questions is required to proceed with the rest of the module, which is consistent with the diagnostic criteria for major depressive disorder. In adapting this module for clinical purposes, we broadened possible response options to the symptom questions to include not only “nearly every day for the past 2 weeks” but also “more than half the days for the past 2 weeks.” This adaptation is consistent with the adjustment used by Spitzer et al.20 in their validation of the Patient Health Questionnaire for Depression. Lowering the frequency threshold may help identify service members who meet criteria for other depression diagnoses, such as depressive disorder not otherwise specified or adjustment disorder with depressed mood. The interview module for depression still provides cutoff values that can be used to guide clinical decision-making. For example, if an individual endorses at least five of the nine symptoms, then he or she is likely to need further evaluation. However, if an individual does not meet these criteria, then the clinician can ask additional questions and consider the overall symptom picture and the individual’s resources before assessing the need for follow-up evaluation. Suicide Risk

Although it is not a concern commonly reported by military personnel after deployment, suicide risk is of critical importance. DD Form 2900 includes two items assessing self-harm that are asked directly by a provider and are not included as part of the self-report survey. For follow-up evaluation on these items, we have included the MINI module on suicidality as part of the interview guide. The module consists of six questions about suicidal thoughts, plans, and attempts, with assigned point values for each question. The cutoff values

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provided by Sheehan et al.14 determine the follow-up evaluation recommended, ranging from no follow-up evaluation to immediate follow-up evaluation. These cutoff values are included in the interview guide itself (see Fig. 1). Post-Traumatic Stress Disorder

The mental health consequence most frequently associated with combat deployment is post-traumatic stress disorder (PTSD).19 The four questions on DD Form 2900 addressing PTSD were developed by Prins et al.21 and are referred to in the literature as the Primary Care-PTSD screen. The best balance of sensitivity and specificity is associated with a cutoff value of two or more positive responses.10 In the interview guide, the questions regarding symptoms of PTSD have been adapted from the MINI module. The differences between the MINI version and the version used in the interview guide are in how symptoms are counted, rather than the questions themselves. In the original MINI module, there were two initial questions reflecting criterion A from DSM-IV (exposure to a traumatic event and an emotional response of fear, helplessness, or horror). In the clinical interview guide, only exposure to a traumatic event is required to continue with this module. The decision to limit the initial criterion to traumatic exposure was based on research findings indicating that many soldiers do not endorse feeling helpless, horrified, or afraid in relation to a combat-related event but do endorse PTSD symptoms.22 Beyond the criterion A requirements, there were also differences in how criteria B, C, and D were addressed in the clinical interview. In the original MINI, items for criterion B (re-experiencing symptoms) are combined into one question. In the interview guide, we created individual questions for each of these items to reflect DSM-IV more closely. Therefore, there are a total of 17 questions, reflecting each of the 17 symptoms listed in DSM-IV. Furthermore, in the original MINI, individuals must meet criteria for each of three symptom categories (re-experiencing, avoidance, and hyperarousal) before continuing with the module. For our purposes, the interviewer asks all 17 questions to assess PTSDrelated problems more inclusively. Significant distress, functional impairment, and required symptoms per category are maintained as stringent criteria for PTSD. It is possible, however, for soldiers to be referred for follow-up PTSD

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assessment through endorsement of at least six symptoms, regardless of symptom category. Anger Problems

Although anger problems are not directly linked to a diagnostic category, they have the potential to affect military job performance, unit cohesion, the safety of others, and comorbid symptoms. Previous research with redeploying military personnel linked exposure to deployment-related events with increased aggression23 and severe family abuse.24 Three items on DD Form 2900 assess anger problems. The items ask about increased irritability, serious conflicts with others that cause worry or concern, and thoughts or concerns of hurting or losing control with someone. Correspondingly, an anger module, composed of five questions that evaluate significant anger problems, is included in the interview guide. The first two questions are stem items and reflect whether there is a risk for loss of control and harming others. If at least one of these items is endorsed, then three additional questions regarding plans to harm others and a history of harming others are asked. If at least one of these latter three items is endorsed, then the individual is referred for further evaluation, taking into account other information as needed. Relationship Problems

Relationship questions are also included as an interview module because of research results regarding the risk of severe spouse abuse among redeploying military personnel.16 Two questions on DD Form 2900 address relationship concerns. One item asks service members whether they are concerned by serious conflicts with their spouse (as part of the anger question mentioned above), and one item asks whether service members are interested in receiving assistance for a family or relationship concern. In the interview guide, four questions assess serious relationship problems. The first two questions establish whether the service member is in a significant relationship. The remaining two questions establish whether there is serious conflict or potential conflict in the relationship. These criteria relate broadly to V-codes for relationship problems found in the DSM-IV.15 Alcohol Problems

On DD Form 2900, alcohol problems are assessed by using a two-item conjoint screen for alcohol problems.25 The two items are as follows. “In the past month, have you used alcohol more than you meant to?” “In the past month, have you felt you wanted or needed to cut down on your drinking?” Each item is answered either yes or no, and two yes responses indicate the need for further evaluation.10 Although the MINI has an alcohol module that assesses alcohol abuse and dependence, we selected the 10-item Alcohol Use Disorders Identification Test (AUDIT)26 for use in the clinical interview because it has been recommended for military populations27 and yields continuous scores, which can identify a range of alcohol-related problems.

A cutoff value of 16 was selected for the screening procedure to identify service members with clinically significant symptoms of alcohol abuse. According to the scale authors, scores starting in this range indicate harmful or hazardous drinking that requires brief counseling and monitoring. This cutoff value was selected rather than the typical cutoff value of 8 because we were interested in identifying service members requiring follow-up evaluation and clinical services and not only basic education about drinking, which occurs in required training programs for military personnel (see the report by Babor et al.26 for a discussion of appropriate AUDIT cutoff values depending on the population). In addition, the directions for the AUDIT needed to be slightly adjusted. Typically, individuals are instructed to consider the questions as they apply to the past year. Because service members were deployed to an alcohol-free environment, these directions were modified to ask about alcohol use in the past 4 weeks. Therefore, the time frame of reference for the AUDIT was shortened, given the timing of the postdeployment validation studies and the requirement to compare the results with DD Form 2900, which assesses alcohol use in the past 4 weeks. Sleep Problems

Sleep problems were specifically added as an interview module as the result of findings from a content validity analysis of screening data collected from military personnel at redeployment.28 In that study, sleep problems were the second most frequent referral category after traumatic stress but often overlapped with other reasons for mental health referral. In addition, sleep problems are commonly associated with both traumatic stress and depression, can affect functioning and levels of distress, and may be an early indication of some other clinical dimension.29 It is not known whether sleep problems are a unique response to combat stress; however, follow-up analyses of sleep data from surveys conducted with military personnel 3 to 4 months after deployment demonstrated the link between sleep problems and combat exposure.30 Sleep problems also may have less stigma than other mental health problems and may serve as a socially acceptable conduit to mental health services. DD Form 2900 assesses sleep problems through one item, that is, problems sleeping or still feeling tired after sleeping. The module on sleep problems was developed specifically for the clinical interview and is based on DSM-IV criteria for primary insomnia. It includes two items assessing sleep difficulties (e.g., difficulty falling or staying asleep or restless or fragmented sleep). For those who endorse either symptom, six other questions are asked to clarify the context of those symptoms. These additional items are also based on DSM-IV guidelines and assess the degree to which sleep problems are related to distress, medications, medical conditions, or environmental distractions. Two final questions ask whether the sleep problem is related to feeling stressed and whether the individual wants a referral for sleep problems.

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Clinical Interview Guide Other Problems

Four additional items in the interview guide assess interest in clinical services, including whether there are any other problems that might be of concern, whether the service member is currently in mental health treatment or was in treatment while deployed, and whether the individual would like to receive counseling. Other clarifying questions can be asked during this stage to help the interviewer determine clinical areas in need of follow-up evaluation.

RESULTS The interview guide was pilot-tested with a combat arms battalion of soldiers as part of the postdeployment psychological screening validation research. The screening was conducted 3 to 4 months after a 1-year deployment to Operation Iraqi Freedom. This was the first deployment to Iraq for these soldiers. Although participation in the postdeployment screening program was command-directed, all soldiers included in the analysis consented to having their data used for research purposes. In all, 780 soldiers were screened using a screening survey, and 722 (92.6%) consented to have their data analyzed. Of the 722 soldiers, 29.2% (n ⫽ 211) exceeded cutoff criteria on the screening survey and were interviewed and 70.8% (n ⫽ 511) did not exceed cutoff criteria. Of those 511, 30.5% (n ⫽ 156) were randomly selected for a brief clinical interview conducted by mental health clinical specialists (see the report by Wright et al.12 for a review of the process). Therefore, a total of 367 soldiers were interviewed using the structured clinical interview; 211 (57.5%) exceeded criteria on the screening survey, and 156 (42.5%) did not. The data presented here are based on results for the 367 soldiers who were interviewed and focus on the 135 soldiers who were referred for follow-up evaluation by clinical providers using the interview guide. It should be noted that neither the interviewers nor the soldiers being interviewed knew the results of the screening survey. It also should be noted that percentages were weighted in favor of those exceeding screening cutoff values and should not be viewed as population prevalence estimates. Demographic characteristics for the soldiers who participated in a clinical interview are provided in Table I. There were no demographic differences between the interviewed sample and the total sample of soldiers. Table II provides a summary of the results for each interview module based on referrals using the criteria in the interview guide. Because each soldier received a complete interview, questions were asked regarding all of the clinical dimensions. In addition, the interviews were conducted by clinical staff members who were blinded to the results of the screening survey. Using this procedure, we were able to determine how effective the interview guide was in identifying soldiers requiring further evaluation, as well as the different problem areas that were detected by using the modules to guide the interview. Specific details concerning sensitivity

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TABLE I.

Sample Demographic Characteristics (N ⫽ 367) Variable

Rank Junior enlisted personnel Noncommissioned officers Officers and warrant officers Years in the military ⱕ5 6–10 ⬎10 Age (years) 18–20 21–25 26–30 31–35 36–40 ⱖ41 Gender Male Female Education High school diploma/GED Some college Bachelor’s degree Graduate degree Marital status Single Married Separated, divorced, or widowed Ethnicity Caucasian African American/black Hispanic Other Asian

n (%) 180 (49.5) 148 (40.7) 36 (9.9) 236 (64.5) 79 (21.6) 51 (13.9) 36 (9.9) 166 (45.9) 94 (26.0) 38 (10.5) 24 (6.6) 4 (1.1) 354 (96.5) 13 (3.5) 187 (51.3) 142 (39.0) 34 (9.3) 1 (0.3) 170 (46.3) 169 (46.0) 28 (7.6) 253 (69.5) 49 (13.5) 43 (11.8) 14 (3.8) 5 (1.4)

GED, general equivalency diploma.

and specificity values and measures of diagnostic efficiency for the screening survey instrument were detailed by Bliese et al.10 and Wright et al.12 However, Table II presents results on the performance of the interview guide for soldiers who required further follow-up care. The majority of soldiers referred for depression-related problems and for PTSD were identified by using the structured interview modules. Most soldiers referred for PTSD were identified by using the broadened PTSD criteria. Of the 11 soldiers referred for suicidality, 100% exceeded the cutoff values in the suicide module of the interview guide. No one was referred who scored below the MINI cutoff value. The soldiers referred for anger problems met the interview guide criteria for anger, with an additional seven soldiers referred on the basis of clinical judgment, six of whom self-referred during the interview. A number of soldiers were referred for sleep problems, with ⬎70% of them answering yes to the question, “Would you like help dealing with the sleep problem?” Finally, of the 16 soldiers referred for other problems, 14 were also referred on the basis of one of the symptombased modules.

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Clinical Interview Guide TABLE II.

Service Members Referred on the Basis of the Interview Guide Interview Module

No. Referred (%)

Depression Met stringent criteria for depression with functional impairment Met stringent criteria for depression without functional impairment Met adapted criteria for depression using broadened response option (e.g., “more than half the days for the past 2 weeks”) Had depression symptoms but did not meet criteria Suicide risk, met MINI criteria PTSD Met stringent criteria for PTSD (including criteria A1 and A2) with functional impairment Met stringent criteria without functional impairment Met broadened criteria (criterion A1 and any 6 of 17 symptoms) Had PTSD symptoms in combination with multiple problem areas Anger problems Met interview guide criteria for anger problems Did not meet criteria but referred for anger Relationship problems Met interview guide criteria for relationship problems Did not meet criteria but referred for relationship problems Alcohol problems Met interview guide criteria for alcohol problems (AUDIT cutoff value of 16) Did not meet criteria but referred for alcohol problems Sleep problems Other problems (work-related problems or family problems other than with spouse)

54 (7.5) 11 (20.4) 20 (37.0) 13 (24.1)

10 (18.5) 11 (1.5) 81 (11.2) 5 (6.2)

9 (11.1) 59 (72.8) 8 (9.9) 28 (3.9) 21 (75.0) 7 (25.0) 16 (2.2) 14 (87.5) 2 (12.5) 24 (3.3) 21 (87.5) 3 (12.5) 66 (9.1) 16 (2.2)

Data are based on results for 135 service members referred for further evaluation. Totals reflect overlapping problem areas identified with the interview guide modules.

DISCUSSION We recommend using the entire guide to conduct a systematic interview for service members who exceed criteria for any single clinical dimension. This option is the most effective screening strategy, based on analyses that demonstrated that the overall sensitivity of screening is increased if service members are assessed in multiple clinical domains in triage interviews.10,12 The finding that the relationships of clinical dimensions to each other help to increase overall sensitivity has also been tested and validated by using computer simulations.31 The advantage of this interviewing approach is that it checks a range of key symptom areas known to be relevant to service members after deployment. In addition, because some symptom areas are likely to be comorbid with others (e.g., anger and sleep problems), the context of these symptoms can be more thoroughly evaluated. If the provider uses only the modules that correspond

to the clinical dimensions the service member endorsed on the survey, then other symptom areas may be overlooked and the full symptom picture may be missed. In addition, other analyses demonstrated improved effectiveness of screening instruments for military samples if multiple specific clinical dimensions (e.g., depression and traumatic stress) are assessed, rather than relying on single scales that assess broad symptoms of distress.12 This increased sensitivity occurs because symptoms tend to be correlated. As noted by Bliese et al.,10 a total of 21 soldiers in this postdeployment sample were referred for follow-up evaluation of PTSD after being interviewed although they had not been identified as positive on the PTSD scale in the screening survey (rather, they had indicated some other clinical dimension, e.g., anger, alcohol, or depression). However, because the interviewers asked questions related to each clinical dimension, the soldiers were determined to have traumatic stress symptoms and the appropriate follow-up evaluations were performed. In a global review of overlapping symptom dimensions in this sample, we found that ⬃34% of the soldiers were referred for only one clinical dimension and ⬃66% were referred for more than one dimension. We think this finding adds to the value of the interview guide for clinical providers, in that the identification of different problem areas provides additional information and allows for more informed decisions concerning treatment options. Consequently, to maximize the value of screening, we recommend that service members be interviewed for multiple dimensions if they indicate any one dimension. The interview guide developed and implemented in this research includes modules that can facilitate a comprehensive triage assessment of each dimension. Epidemiological research conducted with service members returning from Iraq and Afghanistan has documented high rates of mental health problems.19 There is also evidence that combat duty in Iraq is associated with high levels of use of mental health services and attrition from military service.4 However, many service members are not being linked with the services they need.4,32 The objective of the PDHRA program is to ensure that service members receive careful mental health triage; to accomplish that objective, the screening procedure must be sensitive enough to identify service members with symptoms but specific enough to minimize the number of false-positive results. The inter-relationships of clinical dimensions can increase the overall sensitivity of screening if service members are interviewed by using previously determined clinical domains. Additional studies are needed to validate the use of the interview guide as a positive addition to the PDHRA screening process. Program evaluation studies from the perspective of clinical providers who use the guide may also provide information to improve the procedure. In addition, more research should be conducted on the value of interviewing across all clinical dimensions. Although this comprehensive triage was found in previous studies12 to be more effective in identifying service members requiring follow-up evaluation, additional assessment of overlapping dimensions may improve the sensitivity of the

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screening process. Further assessment of sleep and anger problems is also indicated. These two clinical dimensions were included as modules in the interview guide as the result of findings from content validity analyses.16,28 However, future research should examine how the sleep and anger items perform in population mental health screening. Although no study has been conducted that compares the PDHRA process as currently implemented and the value added by including the interview guide in the process, there is some evidence from the validation studies for the PDHRA items to justify the use of the interview modules to support the triage of service members. For example, the structured clinical interview guide can be used as a training tool for providers responsible for briefly assessing the behavioral health of service members returning from combat. Although there is a range of experience in conducting interviews among providers, typically providers are not trained to conduct these kinds of brief mental health interviews. The interview guide is designed to support providers responsible for implementing the PDHRA program. ACKNOWLEDGMENTS We thank the USAMRU-E Screening Team for help with the research. This work was funded by the Military Operational Medicine Research Area Directorate, U.S. Army Medical Research and Materiel Command (Fort Detrick, Maryland). The research was conducted under a human use protocol approved by the institutional review board of the Walter Reed Army Institute of Research.

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