Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members: A Pilot Study
Phase: EARLY_PHASE1
Conditions: Stress Disorders, Post-Traumatic
Sponsor: The University of Texas Health Science Center at San Antonio

COVER PAGE  
PROTOCOL (INCLUDES STATISTICAL ANALYSIS PLAN)  
Study Title:  Augmenting Massed Prolonged Exposure with a Stellate Ganglion Block to Treat 
Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members:  A Pilot Study 
NCT number: NCT04302181 
Document Date: December 21, 2020 

 
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1.  PROTOCOL TITLE:  Augmenting Massed Prolonged Exposure with a Stellate Ganglion Block to Treat Posttraumatic 
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Stress Disorder (PTSD) in Active Duty or Retired Service Members:  A Pilot Study 
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2.  ABSTRACT   
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Active duty service members and veterans with combat-related posttraumatic stress disorder (PTSD) have a lower response 
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rate to evidence-based cognitive behavioral PTSD treatments (e.g., Prolonged Exposure) than their civilian counterparts 
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(Steenkemp et al, 2015). Stellate ganglion blocks are an emerging treatment that may hold promise as an adjunctive 
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treatment for PTSD when combined with an evidence-based treatment such as Prolonged Exposure. To date, no study has 
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examined the potential benefits of a stellate ganglion block over and above cognitive behavioral treatment alone. This open-
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label pilot study will examine the safety and effectiveness of combining Massed Prolonged Exposure with a stellate ganglion 
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block. The study will recruit 12 active duty or retired service members (age 18 to 60 years) who meet DSM-5 diagnostic 
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criteria for PTSD on the Clinician-Administered Posttraumatic Stress Scale-DSM-5 at the baseline assessment. Participants 
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will receive ten sessions of Prolonged Exposure (90-minute sessions) over the course of two consecutive weeks. The stellate 
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ganglion block will be administered between the 1st and 2nd Prolonged Exposure sessions. Participants will be asked to 
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complete assessment measures during treatment and one- and three-months following the completion of treatment. This 
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study will provide valuable information about a novel intervention, stellate ganglion block, that may enhance cognitive 
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behavioral PTSD treatment outcomes in active duty and retired service members.  
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3.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS.  
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The primary research objective is to conduct a pilot study exploring the potential treatment effectiveness and safety of a 
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stellate ganglion block combined with Massed Prolonged Exposure in reducing PTSD symptoms in active duty and retired 
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service members (N =12). The second objective of the pilot is to examine whether the combination of both treatments will 
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reduce comorbid symptoms more than was found in a recently completed trial of Massed Prolonged Exposure in active 
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duty service members (Foa et al, 2018).  
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Aim: To conduct a pilot study to evaluate the safety and effectiveness of a stellate ganglion block (with ropivacaine) 
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combined with Massed Prolonged Exposure for the treatment of PTSD in active duty and retired military service members. 
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Hypothesis 1: More than 50% of the patients who receive the stellate ganglion block and Massed Prolonged Exposure 
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will no longer meet the clinician-assessed PTSD diagnostic criteria on the CAP-5 at one-month and three-month follow-
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up. 
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Hypothesis 2: More than 50% of the patients who receive the stellate ganglion block and Massed Prolonged Exposure 
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will have a 10 point or greater reduction in PTSD symptoms on the PCL-5 at one-month and three-month follow-up.   
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Hypothesis 3: The adverse events associated with the stellate ganglion block will be minimal and temporary.  
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4.  MILITARY RELEVANCE   
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When left untreated, posttraumatic stress disorder (PTSD) can persist for decades and is associated with marked 
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functional impairment including increased risk of depression, suicidality, substance abuse, relationship dysfunction, 
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healthcare utilization, missed work days, and disability (Crum-Cianflone et al., 2016; Jacobsen et al., 2001; Lambert et al., 
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2012; Maynard et al., 2017; Stanley et al., 2019). Following almost two decades of combat deployments to Afghanistan, 
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Iraq, and surrounding locations, PTSD poses a significant threat to the United States’ military force strength and places 
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additional strains on the Veterans Health Administration. Estimates of the numbers of service members and veterans 
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returning from these deployments with PTSD are as high as 20% (range: 7-20%; Institute of Medicine, 2014; Richardson 
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et al., 2010). Importantly, these estimates do not include service members who develop PTSD through sexual or physical 
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assaults, motor vehicle accidents, and other non-combat related traumas. Given the costs associated with military training 
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and the potential loss of knowledgeable and experienced service members, it is in the best interest of the military to 
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provide opportunities for service members with PTSD to receive highly efficacious treatments that enable them to become 
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fully fit for worldwide duty. Because those who cannot be treated into remission are at a significant risk for discharge from 
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active duty, the provision of PTSD treatments that are both highly efficacious and accessible to active duty military 
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personnel are urgently needed.   
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HUMAN SUBJECTS RESEARCH  
 PROTOCOL APPLICATION – Part B 

 
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5. BACKGROUND AND SIGNIFICANCE.   
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Trauma-focused therapies such as Prolonged Exposure (PE) are effective in reducing PTSD symptoms below the 
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diagnostic threshold in up to 80% of patients in civilian populations (Bisson et al., 2007; Institute of Medicine, 2008, 
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2014b; Resick et al., 2002), with treatment improvements lasting for years (Resick et al., 2012). However, the treatment of 
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combat-related PTSD in active duty and veteran populations has been less successful with only 50% experiencing 
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significant symptom reduction following treatment (Steenkamp et al., 2015).The need for treatments that produce higher 
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response rates in active duty military is paramount. 
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In a seminal study, STRONG STAR (South Texas Research Organizational Network Guiding Studies on Trauma and 
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Resilience) examined the effects of PE in 366 service members with combat-related PTSD (Foa et al., 2018). While PE is 
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traditionally delivered in weekly sessions over the course of months, this format can pose unique obstacles to care for 
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military patients. Therefore, in an effort to enhance treatment accessibility, the study team developed a Massed Prolonged 
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Exposure protocol that compresses treatment into once daily treatment over a two-week period. The treatment efficacy of 
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Massed Prolonged Exposure (ten 90-minute sessions in two weeks) was compared to spaced PE (ten 90-minute sessions 
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in 10 weeks). Importantly, massed PE and spaced PE were equally efficacious with approximately 50% of patients 
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experiencing reductions in their PTSD symptoms below diagnostic threshold. Additionally, massed PE had a lower drop 
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out-rate from treatment (13.6% versus 24.8%, respectively) and fewer reported adverse effects. While the results of this 
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study are promising, there is room for improvement.   
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Stellate ganglion blocks (SGBs) are an emerging treatment that may hold promise as an adjunctive treatment for PTSD 
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when combined with an evidence-based treatment such as PE. SGBs are typically used for pain management (Gunduz & 
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Kenis-Coskun, 2017). The use of SGB to treat PTSD was first reported by Lipov and colleagues (2008) as a means to 
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block physiological stress response symptoms associated with PTSD. Since this report, case studies and small clinical 
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trials have provided support for SGB’s efficacy in treating PTSD in military populations. Reduction in PTSD symptoms has 
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been reported within hours of the procedure, with researchers noting the largest reductions in symptoms of hyperarousal 
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and avoidance (Lipov et al., 2012; Lynch et al., 2016). In a case series of 166 active duty patients, Mulvaney and 
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colleagues (2014) found that the majority of patients experienced significant reductions in PTSD symptoms that remained 
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3 to 6 months following the procedure. On the other hand, a randomized clinical trial with active duty service members 
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and veterans found no difference between those who received a SGB consisting of 5mL of 0.5% ropivacaine and those 
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who received a sham injection in symptom reduction (Hanling et al., 2016). However, their sample size was small (N = 
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42), and the majority of participants were undergoing medical disability evaluation boards, leading researchers to suggest 
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that larger trials with populations less susceptible to possible secondary gains need to be conducted (Hanling et al., 2016; 
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Summers & Nevin, 2017). Furthermore, there was no control of prior or ongoing evidence-based behavioral therapy in this 
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study. Thus, SGB may be an appropriate adjunct to increase efficacy of PTSD treatment. To date, no study has examined 
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the potential benefits of combining SGB with an evidence-based behavioral treatment such as PE.  
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6.  RESEARCH DESIGN   
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This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion 
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block combined with Massed Prolonged Exposure. Each of the 12 participants will receive ten 90-minute sessions of 
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Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.   
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7.  RESEARCH PLAN 
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7.1 Selection of Subjects 
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7.1.1. Subject Population.  
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The study sample will consent and screen up to 27 active duty and retired service members recruited in the community and 
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through Brooke Army Medical Center (BAMC), JBSA-Fort Sam Houston, Texas to analyze data from at least 12.  
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7.1.2. Source of Research Material. All measures are being administered for research purposes. For a complete list of 
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measures, see Section 7.3.  
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Source of Research Material 
Clinical Purposes (Y/N) 
Research Purposes (Y/N) 
AHLTA Clinical Records 
Yes 
Yes 

 
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Clinician Rating Scales 
No 
Yes 
Self-Report Questionnaires 
No 
Yes 
 
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7.1.3. Inclusion and Exclusion Criteria.  
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Inclusion Criteria 
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1. Active duty or retired military service member (age 18- 65 years) as assessed with the Demographics and Military 
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Service Characteristics Form  
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2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5) 
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3. Able to speak and read English (due to standardization of outcome measures) 
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4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for 
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the stellate ganglion block. 
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Exclusion Criteria  
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1. Current suicidal ideation severe enough to warrant immediate intervention (as determined by the Depressive 
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Symptoms Index – Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form and 
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corroborated by a clinical risk assessment by a credentialed provider).   
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2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by 
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the Mini International Neuropsychiatric Interview, 7.0 Psychosis and Mania modules and corroborated by clinical 
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judgment).   
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3. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician 
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judgment. 
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4. Symptoms of moderate to severe substance (to include alcohol) use  warranting immediate intervention based on 
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participant self-report on the Alcohol Use Disorders Identification Test, observation of participant behavior, and clinical 
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judgment. 
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5. Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding as determined by a positive urine pregnancy 
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test or by a “yes” response on the Supplemental Health Questionnaire for SGB. 
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6. Current anticoagulant use as determined by a “yes” response on the Supplemental Health Questionnaire for SGB. 
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7. History of bleeding disorder as determined by a “yes” response on the Supplemental Health Questionnaire for SGB. 
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8. Infection or mass at injection site as determined by a “yes” response on the Supplemental Health Questionnaire for 
134 
SGB. 
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9. Myocardial infarction within 6 months of procedure as determined by a “yes” response on the Supplemental Health 
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Questionnaire for SGB. 
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10. Pathologic bradycardia or irregularities of heart rate or rhythm as determined by a “yes” response on the 
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Supplemental Health Questionnaire for SGB. 
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11. Symptomatic hypotension as determined by a “yes” response on the Supplemental Health Questionnaire for SGB. 
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12. Phrenic or laryngeal nerve palsy as determined by a “yes” response on the Supplemental Health Questionnaire for 
141 
SGB. 
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13. History of glaucoma as determined by a “yes” response on the Supplemental Health Questionnaire for SGB. 
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14. Uncontrolled seizure disorder as determined by a “yes” response on the Supplemental Health Questionnaire for SGB. 
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15. History of allergy to local anesthetics as determined by a “yes” response on the Supplemental Health Questionnaire 
145 
for SGB. 
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7.1.4. Description of the Recruitment and Prescreening Process.   
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Participants will be continuously recruited through the community and Brooke Army Medical Center (BAMC), JBSA-Fort Sam 
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Houston, Texas through provider referrals, recruitment events, flyers strategically placed at Fort Sam Houston, study 
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information on the STRONG STAR website, and social media. Providers can give their patients contact information for the 
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study staff so that interested individuals may contact STRONG STAR directly. Alternatively, providers can obtain consent to 
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contact from their patients that allows the study staff to contact the potential participant directly.  Medical records will not be 
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reviewed for recruitment purposes. Instead, study participants will be provider-referred or self-identified. 
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Under an IRB-approved HIPAA Waiver of Authorization, study personnel will conduct a brief discussion by telephone 
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where the basic study inclusion and exclusion criteria will be reviewed to help the individual determine if he or she meets 
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the study criteria or has obvious exclusions from the study protocol so as to prevent individuals from making unnecessary 
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travel for consent and more in-depth screening.  This information will be entered into a secure database as a phone call to 
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a potential participant or a phone call from a potential participant: name, phone number, name of study the caller is 
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interested in, referral date, referral source, potential eligibility status, reason if not eligible, and verbal permission to 
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contact the caller in the future for other studies. We will also record the date and time of the call, outcome of the call, and 
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any notes.  Subjects who agree to study participation will sign a consent document before any further screening will take 
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place.  Any individually identifiable information and Protected Health Information (PHI) collected on individuals who do not 
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consent to participation will not become part of the research data.  If participants agree to participate in the research, the 
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identifiable data collected will become part of the participants’ research records and will be stored according to the 
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research confidentiality plan.   
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Active duty or retired military service members who are not eligible or interested in other IRB-approved STRONG STAR 
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protocols will be told about this study.  If interested, a member of the research team will review eligibility with these 
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potential participants over the phone.  If the person believes they may qualify for the study, the participant will be 
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scheduled for an appointment in which consent will be obtained, and if authorized, the first baseline assessment will be 
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completed.   
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7.1.5. Consent Process.  
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During the consent appointment, potential participants will have the study explained to them in a private location in-person 
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using a paper form at the UTHSCSA STRONG STAR offices located at 7550 IH10 West, Suite 1325, San Antonio, TX 
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78229 or online using an electronic consent (eConsent). The preferred method is to use the eConsent process.  Potential 
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participants will be provided a link to the informed consent document (ICD). The potential participant will be given a copy 
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of the informed consent document (ICD) to read. After the potential participant has read the ICD, they will be given the 
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opportunity to take the consent home to discuss the research with family and friends. The research team, including a 
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research nurse, will be available to answer any questions about the research. Once the potential participant has reached 
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a decision, a member of the study team will review the risks and benefits of the study and ensure the participant 
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understands the research.  The participant will sign the consent form either electronically or on a paper form. A copy of 
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the signed ICD will be given to the participant.  As described in the consent, participants on active duty will have the 
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option of having their Command notified by the Research Staff to ensure active duty Service Members are afforded the 
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time to participate in the study.  Command agreement to allow for duty time to participate in this study is not a requirement 
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for study participation.  A member of the study team will document the informed consent process in the medical record of 
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the participant.  Baseline assessment will occur after consent. 
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7.1.6. Subject Screening Procedures.  
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Once the consent is signed, participants will then be asked to complete the baseline assessments.  The initial consent 
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and screening will require up to 4 hours.  This will include the completion of the questionnaires and interviews outlined in 
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the table in Section 7.3 below.   
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This study involves remote and/or virtual research interactions with participants by the research staff. 
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Research activities will be audio-recorded by an independent device (separate from the conferencing 
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platform, i.e. Zoom). Therefore, privacy and confidentiality is not guaranteed due to the nature of the 
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electronic conferencing platforms that will be used. 
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A baseline assessment will then be scheduled to immediately follow consent.  This may occur in-person using 
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paper forms or the participant will be logged into the STRONG STAR eCAP online data capture 
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system to complete self-report baseline questionnaires.   
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If the participant has been referred from another STRONG STAR study and already undergone baseline testing within the 
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past 30 days, the participant will be asked as part of the consent process to use these assessments rather than repeating 
206 
the assessment battery.  If the participant is newly referred to this study, if it has been more than 30 days since baseline 
207 
testing for another study, or the participant declines use of previously completed assessments, he or she will meet with an 
208 
evaluator and complete the full baseline assessment per protocol. 
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7.1.7. Compensation for participation.   
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Participants will not be compensated for their time.  
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7.2 Drugs, Dietary Supplements, Biologics, or Devices.   
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7.2.1   Ropivacaine will be the drug used in the stellate ganglion block. 
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• 
Complete names and composition of drugs: Ropivacaine (Naropin). 
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• 
Source of the product: BAMC Pharmacy. 
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• 
Location where study product(s) will be stored: In Pyxis MedStation in the Pain Management Procedure Clinic. 
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• 
Dose range, schedule, and administration route of study product(s): 6.5cc of Ropivacaine HCl 0.5%, one time into 
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the stellate ganglion. 
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• 
Detailed description of washout period, if used: not applicable. 
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• 
Duration of study product(s) use: For the duration of the study. 
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• 
Concomitant medications that will be allowed during the study: Only ropivacaine will be used for the stellate 
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ganglion block and during the procedure. 
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Any antidotes and treatments available for potential side effects: None. 
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Plan for disposition of unused study product: Per BAMC Pharmacy and Pain Clinic SOP. 
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• 
FDA regulated studies MUST include the following information:  The FDA has approved the use of ropivacaine for 
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stellate ganglion blocks.  We are not seeking a new indication with this research project. 
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7.2.2   Not applicable, no devices will be used in the conduct of this study.  
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7.3. Research Interventions/Study Procedures.   
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Research Interventions  
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Massed Prolonged Exposure. Prolonged Exposure (PE; Foa, Hembree, & Rothbaum, 2007) is a first-line, empirically 
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supported cognitive behavioral treatment for PTSD and serves as the foundation for massed PE. Massed PE, delivered 
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daily over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and 
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behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms. Ten 90-
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minute sessions of massed PE, which has been found to be non-inferior to ten 90-minute spaced PE delivered once or 
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twice a week over eight weeks, helps minimize military-specific treatment barriers, and decreases treatment dropout rates 
240 
(Foa et al, 2018). For the proposed study, each participant will receive ten 90-minute sessions of massed PE over the 
241 
course of two weeks. Up to three weeks will be allowed to complete the ten sessions of PE and SGB to accommodate 
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scheduling constraints.  Consistent with the standard spaced PE therapy manual, massed PE includes four primary 
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treatment components: (1) psychoeducation on common reactions to trauma; (2) relaxation training; (3) in vivo exposure; 
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and (4) imaginal exposures. In vivo exposure involves approaching avoided situations, people, places, and/or objects that 
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are realistically safe.  With imaginal exposure, participants repeatedly and systematically revisit their trauma memory and 
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related thoughts and feelings. Participants also will be asked to complete homework, including reviewing treatment 
247 
materials, listening to recordings of their imaginal exposure, and completing in vivo exposures. Since massed PE requires 
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considerable time and effort, the study team will work with the participant to receive a release from duty or work while 
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participating in the treatment.  The preferred method of receiving therapy is face-to-face. However, there may be 
250 
circumstances when part or all of the therapy can be administered through telebehavioral/telemedicine health (i. e., phone 
251 
session or using a HIPAA-compliant video calling platform). Decisions will be made case-by-case as issues arise for 
252 
individuals (such as travel restricted because of a worsening of the pandemic or the need for child care) and in discussion 
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with the treatment team. Patients who do not have internet access will need to receive treatment in person. 
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Post-treatment Booster Sessions. Massed PE includes three booster sessions that can last up to 1-hour, scheduled for 1 
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week, 3 weeks, and 7 weeks after the completion of treatment. Booster sessions will be conducted either in person-or by 
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telebehavioral health as appropriate. Since treatment benefits are derived primarily through the 2-week treatment 
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program, there will not be an erosion of benefit for participants who do not have the posttreatment booster sessions.  
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Stellate Ganglion Block (SGB). Standard procedures for sterilization of the equipment and other universal safety 
261 
precautions will be followed. Peripheral intravenous access with a 20-gauge angiocatheter will be obtained as a safety 
262 
precaution in the event an intravascular injection occurs during the placement of the SGB requiring intervention. 
263 
Participants will be positioned supine on a table and placed into a position that allows optimal visualization of anatomic 
264 
landmarks and needle placement. Noninvasive hemodynamic monitors will be used throughout the procedure. A local 
265 
anesthetic will be used to numb the skin and needle track.  Placement of the SGB will be determined using either 
266 
ultrasound or fluoroscopy guidance, depending upon the providers' preference. For the SGB, ropivacaine will be injected 
267 
on the right in the anterior or anterolateral edge of the longus colli muscle.  
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Study Procedures. 
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Interested service members will be given a brief description of the study and will be asked to participate in a brief 
271 
telephone call to determine initial interest in the study. If the individual is still interested, an appointment will be scheduled 
272 
to meet with research staff to review and document informed consent.  This appointment will be held at the UTHSCSA 
273 
STRONG STAR offices located at 7550 IH10 West, Suite 1325, San Antonio, TX 78229 or may be completed online or by 
274 
phone as described in section 7.1.5.  As described in the consent, participants on active duty will have the option of 
275 
having their Command notified by the Research Staff to ensure active duty Service Members are afforded the time to 
276 
participate in the study.  Likewise, retired service members will have the option of having their work supervisor notified to 
277 
secure their support for participation in the study.  Command or work agreement to allow for duty time to participate in this 
278 
study is not a requirement for study participation.  After signing the informed consent document, participants will complete 
279 
a baseline assessment to determine full eligibility. Structured interviews will be administered by a trained independent 
280 
evaluator with at least a master’s degree education. As all study procedures are for screening or research purposes, the 
281 
item responses will be maintained in the participant’s research file and not be entered into the participant’s electronic 
282 
medical record. 
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284 
During the course of the assessment, if a participant’s symptom reports indicate that he or she is at high risk for suicidality 
285 
according to the “STRONG STAR Suicide_Risk_Assessment_and_Risk-Crisis_Management” SOP, risk management 
286 
procedures outlined in this SOP will be followed.  If the research team feels that hospitalization should be considered, the 
287 
participant’s primary care provider or unit will be contacted to escort the individual to the ED.  If a participant reports 
288 
experiencing psychotic or mania symptoms, or reports dangerous amounts of alcohol and/or substance use, additional 
289 
assessment by a licensed provider for consideration of referral for clinical care and for screening participants out of the 
290 
study will be conducted.  If a participant is determined to be ineligible for the study for any reason, a referral back to the 
291 
referring provider or the patient’s primary care provider for clinical follow-up will be made.   
292 
 
293 
Once it has been determined that individuals meet the inclusion and exclusion criteria, participants will work with the 
294 
research staff to schedule treatment and, if requested, secure a release from duty from their command or work to 
295 
participate in the two-week treatment. Massed PE will be conducted by doctoral-level therapists at the UTHSCSA 
296 
STRONG STAR offices. Participants will meet with their providers for individual, 90-minute sessions. They will then be 
297 
asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy 
298 
session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment 
299 
per day, Monday through Friday, for two weeks. The stellate ganglion block injection will be administered between the first 
300 
and second massed PE session at the BAMC Pain Clinic by qualified medical personnel supervised by MAJ John P. 
301 
McCallin III, MD. The BAMC SOP for the placement of a stellate ganglion block will be followed.  A research nurse will be 
302 
in attendance during the procedure and will recover the participant for at least 1 hour following the procedure. 
303 
 
304 
During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-
305 
related cognitions, and suicidal ideation proceeding sessions 6 and 10. This abbreviated assessment battery will include 
306 
the PTSD Checklist for the DSM-5, Patient Health Questionnaire-9, Depressive Symptom Index – Suicidality Subscale, 
307 
and Posttraumatic Cognitions Inventory and should take less than 15 minutes to complete. The full assessment battery 
308 
outlined in the measure section will be re-administered one- and three-months following the completion of treatment by an 
309 
independent evaluator. These assessments may occur in person at the UTHSCSA STRONG STAR offices or online/by 
310 
phone as needed to accommodate participant scheduling and circumstances. 
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312 
In order to examine the safety of the stellate ganglion block in combination with massed PE for the treatment of PTSD, 
313 
adverse event monitoring will be conducted throughout the treatment phase, at each interim assessment, and again at the 
314 
one-month posttreatment and three-month follow-up assessments.  STRONG STAR has well established standard 
315 
operating procedures for adverse event monitoring. An adverse event that leads to hospitalization will be considered a 
316 
serious adverse event (SAE), and adverse events that are unexpected and increase risk to participants will be considered 
317 
an Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO). SAEs and UPIRSOs will be promptly reported 
318 
to the IRB. The categorization and relatedness of each potential adverse event will be adjudicated by the study team 
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during weekly calls.  
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Study Procedures 
Base 
Line 
PE 
Day 
1 
 
SGB Txt 
between 
Txt PE 
Days 1& 
2 
PE 
Days 
2-5 
Interim 
Assess 
Day 6 
PE 
Days 
6-9 
Interim 
Assess 
Day 10 
PE 
Day 
10 
1wk 
Post 
txt 
3wk 
Post 
txt  
1M 
F/U 
7wk 
Post 
txt 
 3M 
F/U 
Phone Discussion 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
R 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Procedures 
Base 
Line 
PE 
Day 
1 
 
SGB Txt 
between 
Txt PE 
Days 1& 
2 
PE 
Days 
2-5 
Interim 
Assess 
Day 6 
PE 
Days 
6-9 
Interim 
Assess 
Day 10 
PE 
Day 
10 
1wk 
Post 
txt 
3wk 
Post 
txt  
1M 
F/U 
7wk 
Post 
txt 
 3M 
F/U 
Demographics and 
Military Service 
Characteristics Form 
S,R 
 
 
 
 
 
 
 
 
 
 
 
 
Life Events Checklist 
for the DSM-5 
S,R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Deployment Risk and 
Resilience Inventory-2   S,R 
 
 
 
 
 
 
 
 
 
 
 
 
Mini International 
Neuropsychiatric 
Interview (MINI 7.0) 
Psychosis and Mania 
modules  
S 
 
 
 
 
 
 
 
 
 
 
 
 
Health Questionnaire 
R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Health Questionnaire-
Supplemental for SGB 
S 
 
 
 
 
 
 
 
 
 
 
 
 
Self-Injurious Thoughts 
and Behaviors 
Interview short form 
S,R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Depressive Symptom 
Index – Suicidality 
Subscale  
S,R 
 
 
 
R 
 
R 
 
R 
 
R 
R 
 
R 
R 
Clinician-Administered 
PTSD Scale for the 
DSM-5  
S,R 
 
 
 
 
 
 
 
 
 
R 
 
R 
PTSD Checklist for the 
DSM-5  
R 
 
 
 
R 
 
R 
 
R 
 
R 
R 
 
R 
R 
Patient Health 
Questionnaire-9  
S,R 
 
 
 
R 
 
R 
 
R 
 
R 
R 
 
R 
R 
Generalized Anxiety 
Disorder-7 
R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Brief Inventory of 
Psychosocial 
Functioning  
R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Veterans RAND 12-
Item Short Form 
Health Survey  
R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Alcohol Use Disorders 
Identification Test  
S,R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Insomnia Severity 
Index  
R 
 
 
 
 
 
 
 
 
 
R 
 
R 
Posttraumatic 
Cognitions Inventory  
R 
 
 
 
R 
 
R 
 
R 
R 
R 
R 
R 
Credibility and 
Expectancy 
Questionnaire for PE 
 
 
R 
 
 
 
 
 
 
 
R 
 
R 
Credibility and 
Expectancy 
Questionnaire for SGB 
 
 
R 
 
 
 
 
 
 
 
R 
 
R 
Massed Prolonged 
Exposure (PE) 
 
R 
 
R 
 
R 
 
R 
 
 
 
 
 

 
Version 21 December 2020 
 
19-878H, Peterson, Form BB, 01-05-21, AMD                                                                               Page 8 of 18 
 
Study Procedures 
Base 
Line 
PE 
Day 
1 
 
SGB Txt 
between 
Txt PE 
Days 1& 
2 
PE 
Days 
2-5 
Interim 
Assess 
Day 6 
PE 
Days 
6-9 
Interim 
Assess 
Day 10 
PE 
Day 
10 
1wk 
Post 
txt 
3wk 
Post 
txt  
1M 
F/U 
7wk 
Post 
txt 
 3M 
F/U 
Ultrasound or 
Fluoroscopy (for SGB 
placement guidance) 
 
 
R 
 
 
 
 
 
 
 
 
 
 
Stellate Ganglion 
Block (SGB) 
 
 
R 
 
 
 
 
 
 
 
 
 
 
Adverse Event 
Monitoring  
 
R 
R 
R 
R 
R 
R 
R 
R 
R 
R 
 
R 
R 
Urine Pregnancy Test 
S 
 
 
 
 
 
 
 
 
 
 
 
 
Booster Sessions  
 
 
 
 
 
 
 
 
R 
R 
 
R 
 
 
322 
Key: R = administered for research purposes, S = administered for screening purposes 
323 
 
324 
7.3.1 Collection of Human Biological Specimens.  Urine pregnancy tests will be conducted at baseline. 
325 
 
326 
7.3.1.1 Laboratory evaluations and special precautions. Urine pregnancy test will be conducted at baseline and the 
327 
remaining sample will be discarded.  Universal precautions will be followed when collecting and testing all urine samples. 
328 
 
329 
7.3.1.2 Specimen storage. Not applicable  
330 
 
331 
7.3.2 Data Collection.   
332 
A comprehensive list of assessments is included in the Section 7.3 table. The data collected in the study will be coded 
333 
using an assigned number. Hard copies of data collected during the study will securely stored in locked cabinets at the  
334 
STRONG STAR offices. Data will be entered into the STRONG STAR database on a secure UTHSCSA server (physically 
335 
located at the Advanced Data Center), by member of the research team.  Electronic data will be stored, managed, and 
336 
analyzed by the STRONG STAR – Data and Statistics Core staff of the STRONG STAR consortium. Every member of the 
337 
Research Team will be trained and monitored about how to handle and protect both medical and research records.  
338 
Furthermore, the Research Team strictly controls access to study data.   
339 
 
340 
7.3.3. Human Biological Specimens/Tissue/Data Banking.  Not applicable 
341 
 
342 
7.4 Statistical Consideration  
343 
 
344 
7.4.1 Sample Size Estimation.  This study is a pilot investigation. Consequently, a power analysis was not conducted. 
345 
 
346 
Estimate Required Sample Size 
12 
Screened Out/Excluded 
12 
Estimate Participant Drop Out / Withdrawal 
3 
Total Enrollment Requirement 
27 
 
347 
 
348 
7.4.2 Primary (i.e., primary outcome variables) and secondary endpoints.  
349 
The primary aim of this pilot is to explore the potential treatment effectiveness and safety of a stellate ganglion block 
350 
combined with Massed Prolonged Exposure in reducing PTSD symptoms in active duty and retired service members. 
351 
Therefore, the primary outcome variables include the CAPS-5 severity score, the PCL-5, and adverse event monitoring. 
352 
Secondary endpoints include associated psychopathology (severity scores on measures of depression, general anxiety, 
353 
disability, and PTSD-related cognitions). 
354 
 
355 
7.4.3 Data analysis.  
356 
Prior to statistical analyses, the data will be carefully inspected to identify such problems as unusual distributions, the 
357 
desirability of transformations (e.g., logarithmic is often useful), missing data, and outliers. Data are also screened to 
358 
identify potentially important covariates, i.e., variables (e.g., age) that are not of primary interest in the hypotheses but that 
359 

 
Version 21 December 2020 
 
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relate to the outcome measures (including such variables as covariates increases power and reduces bias).The primary 
360 
software for statistical analyses is the SAS statistical system, that is widely available and well known. Our current version 
361 
is SAS 9.4. We also have specialized software, including Stata 14, Mplus 8.2, and SPSS 25. 
362 
 
363 
The proposed study is in preparation for a larger clinical trial, with the primary goals of the pilot study being to 
364 
demonstrate feasibility through evaluating recruitment, retention, and adverse events, and to estimate the magnitude of 
365 
potential impact on selected outcomes. A total of 12 participants with PTSD to receive a combination treatment of Massed 
366 
Prolonged Exposure with a stellate ganglion block will be included in the analysis. Assessments will be done at three time 
367 
points (baseline, one- and three-months following the completion of treatment). Statistical analyses will be intent to treat, 
368 
using all data from participants regardless of the extent of participation.  We are requesting to consent up to 27 
369 
participants to include12 participants for analysis. 
370 
 
371 
The primary aim of this project is to evaluate the effectiveness and safety of a stellate ganglion block combined with 
372 
Massed Prolonged Exposure for the treatment of PTSD in active duty and retired military service members. Tests of the 
373 
descriptive hypotheses will involve calculation of the relevant proportions with 95% confidence limits based on PTSD 
374 
diagnosis, PTSD symptom severity, and adverse events over the course of therapy, and dropout.  
375 
 
376 
7.7 Confidentiality.   
377 
All Prolonged Exposure sessions and interview assessments will be delivered in private offices at the STRONG STAR Clinic 
378 
at the UTHSCSA. The stellate ganglion block will be administered in Pain Clinic at the Brooke Army Medical Center following 
379 
standard operating procedures for patient safety and confidentiality. Data will be stored by an assigned participant code 
380 
number so that data records can be viewed by password-authenticated, authorized investigators and Consortium personnel. 
381 
Digital audio recordings of assessments and PE sessions will be labeled with the participant’s study id number and saved on 
382 
a secure password protected server. Those recordings, to be reviewed for fidelity to ensure that the treatment is being 
383 
delivered in accordance with the treatment manual, will be viewed on a secure, password protected server.  There is no option 
384 
for the reviewers to download or otherwise save the recordings to their computers.  Every member of the Research Team will 
385 
be trained and monitored about how to handle and protect both medical and research records.  The recording will be deleted 
386 
from the recorder after it has been saved to the secure password protected server. In the circumstance that an audio 
387 
recording cannot be immediately saved (e.g., network or electrical outage, computer unavailable, etc.), the recording device 
388 
will be placed in a locked file cabinet in the STRONG STAR Clinic offices. Study staff will be responsible to upload the 
389 
recordings as soon as possible and then deleting the recording from the recorder.  Only authorized study staff, and members 
390 
of the STRONG STAR Biostatistics and Data Management Core staff will have access to either the raw data or electronic 
391 
study data. 
392 
 
393 
7.7.1 Certificate of Confidentiality.  We are not seeking a Certificate of Confidentiality. 
394 
 
395 
7.7.2. Data Protection.   
396 
Data will be coded using an assigned number. Data collected during treatment will be placed into a locked filing cabinet 
397 
and stored securely in a locked room by a STRONG STAR staff member. Files will be kept securely at the University of 
398 
Texas Health Science Center (UTHSCSA) STRONG STAR offices in San Antonio. The STRONG STAR data server is 
399 
physically located at the Advanced Data Center (ADC) has 24x7 onsite security, card key, biometric access controls and 
400 
video surveillance. University of Texas Health Science Center at San Antonio (UTHSCSA) ADC facility also maintains 
401 
Gen 2 firewall devices to protect and prohibit any unauthorized access to UTHSCSA data. All UTHSCSA network devices 
402 
are monitored by state of the art monitoring applications that include configuration audit, management, and availability 
403 
24x7.  Every member of the Research Team will be trained and monitored about how to handle and protect both medical 
404 
and research records. Furthermore, the Research Team strictly controls access to study data.  The local study site will 
405 
maintain a list of assignment numbers for the purpose of linking subsequent research materials. 
406 
 
407 
A Data Safety and Monitoring Plan (DSMP) has been developed in accordance with the National Institutes of Health 
408 
Office of Human Research Protection to assure the appropriate clinical safety monitoring of study subjects participating in 
409 
this study.  
410 
 
411 
7.7.3. Long Term Data Storage. 
412 
A STRONG STAR Repository has been approved by both the UTHSCSA (HSC20100475H) IRB to enable the STRONG 
413 
STAR Consortium to store specimens and data for future use. The STRONG STAR Repository will create a large 
414 
comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and 
415 
treatment of PTSD in our active duty and retired veterans of conflicts following 9-11.  All information entered into the STRONG 
416 

 
Version 21 December 2020 
 
19-878H, Peterson, Form BB, 01-05-21, AMD                                                                               Page 10 of 18 
 
STAR Repository will be extracted from primary datasets collected as part of IRB-approved studies, including this study, being 
417 
conducted and /or supported by the projects of the STRONG STAR Consortium.  These study databases will be established 
418 
and maintained by the Biostatistics and Data Management Core of the STRONG STAR Consortium.  A unique, sequential 
419 
alpha-numeric STRONG STAR ID will be assigned to each participant at the time of recruitment into this study. However, all 
420 
Repository data will be identified with a different code number that can be cross linked to the original study code only through 
421 
records maintained by the STRONG STAR Biostatistics and Data Management Core. Data, biological specimens and images 
422 
will constitute the STRONG STAR PTSD Repository. Participation in the repository will be completely voluntary and entirely 
423 
optional which means that a potential participant’s willingness to participate in the repository has no influence upon their 
424 
eligibility to participate in the primary STRONG STAR study they have either already enrolled in or are considering enrolling 
425 
in.  At the conclusion of this study, participants who signed the consent to have their specimens and data placed in the 
426 
STRONG STAR Repository will be maintained under the IRB-approved Repository protocol.  Biological specimens and 
427 
information from study participants who declined participation in the STRONG STAR Repository will be permanently de-
428 
identified (i. e., all PHI will be deleted from the study data bases) and the de-identified blood and information placed in the 
429 
STRONG STAR Repository for future use.   
430 
 
431 
8.0 RISKS/BENEFITS ASSESSMENT 
432 
 
433 
8.1 Risks.   
434 
 
435 
Likely, but Not Serious Risks 
436 
Potential risks associated with the assessments and PE can include temporary increase in relationship distress, becoming 
437 
emotionally upset or experiencing an initial increase of PTSD symptoms due to the consideration of traumatic events. 
438 
Studies with PE suggest that a small minority experience an increase in symptoms of PTSD after the initiation of imaginal 
439 
exposure exercises and for this minority, the distress and increased symptoms are temporary, are not predictive of poor 
440 
outcome, and are not associated with increased likelihood of dropout (Foa et al., 2002).  
441 
 
442 
Potential risks associated with the stellate ganglion block can include a temporary change in skin temperature; temporary 
443 
hoarseness, voice changes or loss of voice; or Horner’s Syndrome.  
444 
 
445 
Potential risks related to ropivacain used in the stellate ganglion block can include signs of an allergic reaction (hives or 
446 
red skin rash; dizziness; sneezing; difficulty breathing; nausea or vomiting; sweating; swelling of your face, lips, tongue, or 
447 
throat; gastrointestinal distress; pain (headache, back pain); skin (itching); numbness or tingly feeling; fever; genital-
448 
urinary (problems with urination or sexual function). 
449 
 
450 
Rare, but Serious Risks 
451 
With the handling of medical and research records there is always the possibility of a breach of confidentiality. However, 
452 
every effort is made to protect the privacy of participants. Every member of the Research Team is carefully trained and 
453 
monitored about how to store, handle, and protect participant records.  
454 
 
455 
Rare but more serious risks associated with the stellate ganglion block include bleeding from a broken blood vessel that 
456 
results in a hematoma; injury to the nerves around the injection site; injury to the esophagus; pneumothorax; spinal cord 
457 
trauma; infection of the tissues of the neck, nerves, bone or disc material in the area of the injection or IV placement; 
458 
incomplete recovery of normal function. 
459 
 
460 
Rare but more serious risks related to ropivacain used in the stellate ganglion block include feeling anxious, restless, 
461 
confused, or like you might pass out; problems with speech or vision; ringing in the ears, metallic taste, numbness or 
462 
tingling around the mouth, or tremors; seizure (convulsions); weak or shallow breathing; slow heart rate, weak pulse or 
463 
fast heart rate, gasping, feeling unusually hot. 
464 
 
465 
Rare but more serious risks if fluoroscopy is used for a prolonged time to guide the placement of the 
466 
block are reddening of the skin, a very slight increase in the chance of contracting cancer, and a 
467 
potential risk to an unborn embryo/fetus should a woman undergoing fluoroscopy be pregnant.  
468 
Normally fluoroscopy will be used for less than one minute. 
469 
 
470 
Concerns for Pregnant and Breastfeeding Women 
471 

 
Version 21 December 2020 
 
19-878H, Peterson, Form BB, 01-05-21, AMD                                                                               Page 11 of 18 
 
It is not known whether ropivacaine can cause birth defects or other problems in an unborn child. Ropivacaine might be 
472 
harmful to (1) an unborn child or (2) an infant who is breast-fed.  Participants should not get pregnant or breastfeed while 
473 
in this study. 
474 
 
475 
Risks of PTSD Diagnosis regardless of Treatment 
476 
Possibility of increased suicidal risk. One of the risks of PTSD both in and out of treatment is attempted suicide, which can 
477 
result in death. 
478 
 
479 
Safeguards for Protecting Participants  
480 
For urgent issues, whether potentially related to the PE or to the stellate ganglion block, participants will be instructed to 
481 
get help immediately by going to the Emergency Department open 24 hours at the Brooke Army Medical Center.  For 
482 
suicidal thoughts, participants can also be advised to call the suicide hotline, or go to a nearby civilian emergency room. 
483 
Each week, the therapist will review the participant’s progress and symptom levels and will provide individualized 
484 
feedback to the participant as needed. Participants complete weekly self-report assessment measures that will assess 
485 
PTSD severity, depressive symptoms, and suicidal ideation. This will allow therapists to closely monitor any increase in 
486 
distress. Individualized safety planning will be utilized as needed by members of the treatment team. Any indication that 
487 
the participant is considering suicide will be handled following the STRONG STAR Consortium SOPs in concert with the 
488 
local site-specific policies and procedures.  Participants can be seen at the Brooke Army Medical Center Emergency 
489 
Department at any time. 
490 
 
491 
The possible risks (i.e., temporary increase in distress and severity) associated with participation are reasonable in this 
492 
context given the level of participant monitoring and access to research and clinical staff. We believe that the possible 
493 
benefits from participating in this study outweigh the possible risks. However, if a service member decides against 
494 
participation, he/she can still access mental health treatment through the Brooke Army Medical Center or Army One-
495 
Source.  
496 
 
497 
Research Monitor:  
498 
Karen Nijland, BPharm will serve as the DoD Independent Research Monitor.  The duties of the research monitor shall be 
499 
determined on the basis of specific risks or concerns about the research. The research monitor may perform oversight 
500 
functions (e.g., observe recruitment, enrollment procedures, and the consent process for individuals, groups or units; 
501 
oversee study interventions and interactions; review monitoring plans and UPIRTSO reports; and oversee data matching, 
502 
data collection, and analysis) and report their observations and findings to the IRB or a designated official.  The research 
503 
monitor may discuss the research protocol with the investigators, interview human subjects, and consult with others 
504 
outside of the study about the research. The research monitor shall have authority to stop a research protocol in progress, 
505 
remove individual human subjects from a research protocol, and take whatever steps are necessary to protect the safety 
506 
and well-being of human subjects until the IRB can assess the monitor’s report. Research monitors shall have the 
507 
responsibility to promptly report their observations and findings to the IRB or other designated official. 
508 
 
509 
8.2 Potential Benefits.   
510 
Potential benefits of participation in this study may include a reduction in PTSD symptoms over the course of therapy.  In 
511 
addition, the knowledge gained from this study will serve to inform the most effective early interventions for the prevention 
512 
and treatment of PTSD in active-duty military personnel. 
513 
 
514 
9.0  ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
515 
 
516 
9.1 Adverse Events will be assessed and monitored according to the established STRONG STAR SOP and the IRB of 
517 
record’s policies and procedures. 
518 
 
519 
9.2 Reporting Unanticipated Problems Involving Risks to Subjects or Others, Serious Adverse Events and Deaths to 
520 
the IRB of Record.   
521 
All adverse events, unanticipated problems involving risk to subjects or others, and deviations will be reported to the 
522 
Institutional Review Board (IRB) in accordance with current IRB policy.  UPIRSOs and recurrent non-compliance with 
523 
study procedures will be reported promptly to the IRB.  All adverse events that do not meet the UPIRSO criteria and 
524 
deviations that are not non-compliance will be summarized at Continuing Review per the IRB of record’s policy. 
525 
 
526 
10.0 WITHDRAWAL FROM STUDY PARTICIPATION.   
527 

 
Version 21 December 2020 
 
19-878H, Peterson, Form BB, 01-05-21, AMD                                                                               Page 12 of 18 
 
Participation in the study may be discontinued by the principal investigator if continued participation is considered a 
528 
danger to a participant’s welfare. Reasons for discontinuation include: 1) a serious adverse event such that continued 
529 
participation would be a danger to the participant; 2) clinical worsening for any reason that is deemed to necessitate non-
530 
study psychological or psychiatric treatment; 3) exacerbation of PTSD, anxiety, or depressive symptoms that the 
531 
participant cannot tolerate; or 4) discontinuation would be in the participant's best interest. Participants deemed 
532 
candidates for discontinuation will be discussed in the weekly conference calls with the therapist and the supervisor and 
533 
will be brought to the attention of the PI for final decision.   
534 
 
535 
Participants who are discontinued from the study for any reason will be scheduled for a final evaluation within one week 
536 
and given appropriate treatment referrals. If participants are discontinued due to a serious adverse event, they will 
537 
continue to be followed clinically by the therapist and/or member of the research staff until the adverse event is resolved 
538 
or becomes stable. If participants are discontinued for a medical or psychiatric reason, they will be given the opportunity to 
539 
either complete the balance of their Massed-PE sessions or to receive a full course of Massed-PE after the condition has 
540 
resolved or stabilized and the endpoint assessment has been completed.  The reason the participants are discontinued 
541 
from the study and any referrals made will be documented.  Participants will be told they will be contacted for follow-up 
542 
whether or not they complete the trial. 
543 
  
544 
11.0 REFERENCES.   
545 
Babor, T. F., Higgins-Biddle, J. C., Saunders, J. B. & Monteiro, M. G. (2001). The Alcohol Use Disorders Identification 
546 
Test: Guidelines for Use in Primary Care, 2nd Edition. Geneva, Switzerland: World Health Organization. 
547 
Barnes, J. B., Presseau, C., Jordan, A. H., Kline, N. K., Young-McCaughan, S., Keane, T. M., Peterson, A. L., Litz, B. T., 
548 
and the Consortium to Alleviate PTSD.* (2019). Common data elements in the assessment of military-related PTSD 
549 
research applied in the Consortium to Alleviate PTSD.  Military Medicine, 184(5-6), e218-e226. doi: 
550 
10.1093/milmed/usy226. 
551 
Bastien, C. H., Vallieres, A., Morin, C. M., (2001). Validation of the Insomnia Severity Index as an outcome measure for 
552 
insomnia research. Sleep Medicine, 2(4), 297-307. 
553 
Batterham, P. J., Ftanou, M., Pirkis, J., Mackinnon, A. J., Beautrais, A., Fairweather-Schmidt, A. K., & Christensen, H. 
554 
(2014, December 15). A systematic review and evaluation of measures for suicidal ideation and behaviors in 
555 
population-based research. Psychological Assessment. Advance online publication. 
556 
http://dx.doi.org/10.1037/pas0000053 
557 
Bisson, J., Ehlers, A., Matthews, R., Pilling, S., Richards, D., & Turner, S. (2007). Psychological treatments for chronic 
558 
post-traumatic stress disorder: Systematic review and meta-analysis. British Journal of Psychiatry, 190, 97-104. 
559 
doi:10.1192/bjp.bp.106.021402 
560 
Borkovec, T. D & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of Behaviour Therapy and 
561 
Experimental Psychiatry, 3, 257-260. 
562 
Cameron, I. M., Crawford, J. R., Lawton, K., & Reid, I. C. (2008). Psychometric comparison of PHQ-9 and HADS for 
563 
measuring depression severity in primary care. British Journal of General Practice, 58, 32-36. 
564 
Crum-Cianflone, N., Powell, T., LeardMann, C., Russell, D., & Boyko, E. (2016). Mental health and comorbidities in U.S. 
565 
Military members. Military Medicine, 181, 537–545. doi:10.7205/MILMED-D-15-00187 
566 
Devilly, G. J., & Borkovec, T. D. (2000). Psychometric properties of the credibility/expectancy questionnaire. Journal of 
567 
Behavior Therapy and Experimental Psychiatry, 31, 73-86.  
568 
Foa, E. B., Elhers, A., Clark, D. M., Tolin, D. F. & Orsillo, S. M. (1999). The Posttraumatic Cognitions Inventory (PCTI). 
569 
Psychological Assessments, 11, 303-314. 
570 
Foa, E., McLean, C., Zang, Y., Rosenfield, D., ... & Peterson, A. (2018). Effect of prolonged exposure therapy delivered 
571 
over 2 weeks vs 8 weeks vs present-centered therapy on PTSD symptom severity in military personnel: A randomized 
572 
clinical trial. JAMA, 319, 354-364. doi:10.1001/jama.2017.21242 
573 
Gunduz, O. H. & Kenis-Coskun, O. (2017). Ganglion blocks as a treatment of pain: Current perspectives. Journal of Pain 
574 
Research, 10, 2815-2826. doi: 10.2147/JPR.S134775.  
575 
Hanling, S., Hickey, A., Lesnik, I., Hackworth, R., Stedje-Larsen, E., Drastal, C., & McLay, R. (2016). Stellate ganglion 
576 
block for the treatment of posttraumatic stress disorder: A randomized, double-blind, controlled trial. Regional 
577 
Anesthesia and Pain Medicine, 41, 494-500. doi:10.1097/AAP.0000000000000402 
578 
Institute of Medicine. (2008). Treatment for posttraumatic stress disorder: An assessment of the evidence. Washington, 
579 
DC: The National Academies Press. 
580 
Institute of Medicine. (2014). Treatment for posttraumatic stress disorder in military and veteran populations: Final 
581 
assessment. Washington, DC: The National Academies Press. 
582 
Jacobsen, L., Southwick, S., & Kosten, T. (2001). Substance use disorders in patients with PTSD: A review of the 
583 
literature. The American Journal of Psychiatry, 158, 1184–1190. doi:10.1176/appi.ajp.158.8.1184 
584 

 
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19-878H, Peterson, Form BB, 01-05-21, AMD                                                                               Page 13 of 18 
 
Kazis, L. E., Selim, A., Rogers, W., Ren, X. S., Lee, A., & Miller, D. R. Veterans RAND 12-Item Health Survey (VR-12): A 
585 
White Paper Summary. Unpublished manuscript. 
586 
http://www.hosonline.org/surveys/hos/download/veterans_rand_12_item_health_survey_white_paper_summary.pdf 
587 
Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. 
588 
Journal of General Internal Medicine, 16, 606-613. 
589 
Kroenke, K., Spitzer, R. L., Williams, J. B., & Lowe, B. (2010). The Patient Health Questionnaire Somatic, Anxiety, and 
590 
Depressive Symptom Scales: A systematic review. General Hospital Psychiatry, 32, 345-359. 
591 
Lambert, J., Engh, R., Hasbun, A., & Holzer, J. (2012). Impact of posttraumatic stress disorder on the relationship quality 
592 
and psychological distress of intimate partners: A meta-analytic review. Journal of Family Psychology, 26, 729–737. 
593 
doi:10.1037/a0029341 
594 
Lipov, E. G., Joshi, J. R., Lipov, S., Sanders, S. E., & Siroko, M. K. (2008). Cervical sympathetic blockade in a patient with 
595 
post-traumatic stress disorder: A case report. Annals of Clinical Psychiatry, 20(4), 227-228.  
596 
Lipov, E. G., Navaie, M., Stedje-Larsen, E. T., Burkhardt, K., Smith, J. C., Sharghi, L. H., & Hickey, A. H. (2012). A novel 
597 
application of stellate ganglion block: Preliminary observations for the treatment of post-traumatic stress disorder. 
598 
Military Medicine, 177(2), 125–127. doi:10.7205/MILMED-D-11-00328 
599 
Lowe, B., Decker, O., Muller, S., Brahler, E., Schellberg, D., Herzog, W., & Herzberg, P. Y. (2008). Validation and 
600 
standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Medical Care, 46, 
601 
266-274. 
602 
Lynch, J., Mulvaney, S., Kim, E., de Leeuw, J., Schroeder, M., & Kane, S. (2016). Effect of stellate ganglion block on 
603 
specific symptom clusters for treatment of PTSD. Military Medicine, 181, 1135–1141.  
604 
Marx, B. P. (2013). Development and validation of a PTSD-related impairment scale. Retrieved from www.dtic.mil/cgi-
605 
bin/GetTRDoc?AD=ADA585414 
606 
Maynard, C., Batten, A., Chuan-Fen Liu, Nelson, K., Fihn, S. D., & Liu, C.-F. (2017). The burden of mental illness among 
607 
veterans: Use of VHA health care services by those with service-connected conditions. Medical Care, 55, 965–969. 
608 
doi:10.1097/MLR.0000000000000806 
609 
Metalsky, G. I., & Joiner, T. E. (1997). The Hopelessness Depression Symptom Questionnaire. Cognitive Therapy and 
610 
Research, 21, 359-384. 
611 
Morin, C.M. (1993). Insomnia: Psychological Assessment and Management. New York, NY: The Guilford Press. 
612 
Mulvaney, S., Lynch, J., Hickey, M., Rahman-Rawlins, T., Schroeder, M., Kane, S., & Lipov, E. (2014). Stellate ganglion 
613 
block used to treat symptoms associated with combat-related post-traumatic stress disorder: A case series of 166 
614 
patients. Military Medicine, 179, 1133-1140. doi:10.7205/MILMED-D-1400151 
615 
Nock, M. K., Holmberg, E. B., Photos, V. I., & Michel, B. D. (2007). Self-Injurious Thoughts and Behaviors Interview: 
616 
Development, reliability, and validity in an adolescent sample. Psychological Assessment, 19, 309-317. 
617 
Resick, P. A., Nishith, P., Weaver, T. L., Astin, M. C., & Feuer, C. A. (2002). A comparison of cognitive-processing therapy 
618 
with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female 
619 
rape victims. Journal of Consulting and Clinical Psychology, 70(4), 880-886. doi:10.1037/0022-006X.70.4.880 
620 
Resick, P., Williams, L., Suvak, M., Monson, C., & Gradus, J. (2012). Long-term outcomes of CBTs for PTSD among 
621 
female rape survivors. Journal of Consulting & Clinical Psych, 80, 201-10. doi:10.1037/a0026602 
622 
Richardson, L., Frueh, B., & Acierno, R. (2010). Prevalence estimates of combat-related PTSD: Critical review. Australian 
623 
and New Zealand Journal of Psychiatry, 44, 4-19. doi:10.3109/00048670903393597 
624 
Rothbaum, B. O., Foa, E. B. & Hembree, E. A. (2007). Reclaiming Your Life from a Traumatic Experience Workbook. 
625 
Oxford, NY: Oxford University Press. 
626 
Saunders, J. B., Aasland, O. G., Babor, T. F., De La Fuente, J. R. & Grant, M. (1993). Development of the Alcohol Use 
627 
Disorders Identification Test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol 
628 
consumption-II. Addiction, 88, 791-804. 
629 
Sheehan, D. V., Lecrubier, Y., Sheehan, K. H., Amorim, P., Janavs, J., Weiller, E., …Dunbar, G. C. (1998). The Mini-
630 
International Neuropsychiatric Interview (M.I.N.I.): The development and validation of a structured diagnostic 
631 
psychiatric interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry, 59, 22-33. 
632 
Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. (2006). A brief measure for assessing generalized anxiety disorder: 
633 
The GAD-7. Archives of Internal Medicine, 166, 1092-1097. 
634 
Stanley, I. H., Rogers, M. L., Hanson, J. E., Gutierrez, P. M., & Joiner, T. E. (2019). PTSD symptom clusters and suicide 
635 
attempts among high-risk military service members: A three-month prospective investigation. Journal of Consulting 
636 
and Clinical Psychology, 87, 67–78. doi:10.1037/ccp0000350 
637 
Steenkamp, M. M., Litz, B. T., Hoge, C. W., & Marmar, C. R. (2015). Psychotherapy for military-related PTSD: A review of 
638 
randomized clinical trials. JAMA, 314, 489-500. doi:10.1001/jama.2015.8370 
639 
Summers, M. R., & Nevin, R. L. (2017). Stellate ganglion block in the treatment of post-traumatic stress disorder: A review 
640 
of historical and recent literature. Pain Practice, 17, 546-553. doi:10.1111/papr.12503 
641 

 
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Vogt, D. S., Smith, B. N., King, L. A., King, D. W., Knight, J. A., & Vasterling, J. J. (2013). Deployment Risk and Resilience 
642 
Inventory-2 (DRRI-2): An updated tool for assessing psychosocial risk and resilience factors among service members 
643 
and veterans. Journal of Traumatic Stress, 26, 710-717.  
644 
Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The Clinician-
645 
Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at 
646 
www.ptsd.va.gov. 
647 
Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G., Marx, B. P., & Keane, T. M. (2013). The Life Events 
648 
Checklist for DSM-5 (LEC-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov. 
649 
Weathers, F. W., Keane, T. M., & Davidson, J. R. (2001). Clinician-administered PTSD scale: A review of the first ten 
650 
years of research. Depression and Anxiety, 13, 132–156. 
651 
Weathers, F. W., Litz, B. T., Herman, D. S., Huska, J. A., & Keane, T. M. (1993). The PTSD Checklist (PCL): Reliability, 
652 
validity, and diagnostic utility. Paper presented at the 9th Annual Conference of the ISTSS, San Antonio, TX. 
653 
Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for 
654 
DSM-5 (PCL-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov. 
655 
 
656 
12.0 TIME REQUIRED TO COMPLETE THE RESEARCH (including data analysis).  
657 
The following table provides an overview of activities that the research team plans to accomplish. We anticipate recruiting 
658 
and treating two eligible service members per month to meet study goals. We anticipate that the study will be completed 
659 
by December 31, 2020. 
660 
  
661 
Activities (Months) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
IRB approvals, prepare materials; train staff on procedures  
 
 
 
 
 
 
 
 
 
 
 
Recruit, screen, and treat 12 participants  
 
 
 
 
 
 
 
 
 
 
 
 
Complete follow-up assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
662 
13.0 STUDY CLOSURE PROCEDURES  
663 
At the conclusion of the study all data will be stripped of identifiers. De-identified (anonymized) data will be maintained 
664 
indefinitely in the STRONG STAR Repository. Informed consent documents will be stored securely for a minimum of three 
665 
years following completion of the research; HIPAA authorizations will be stored for a minimum of six years IAW Federal 
666 
regulations. A protocol completion form will be filed with the IRB. 
667 
 
668 
14.0 DESCRIPTION OF ASSESSMENTS 
669 
The majority of the measures listed below is commonly used, have adequate to good psychometrics, and are part of the 
670 
Consortium common data elements (CDE). As outlined in the National Research Action Plan, evidence-based CDEs and 
671 
measures for STRONG STAR studies will ensure comparability of results across the consortium as well as other clinical trials 
672 
and epidemiological studies of PTSD.  
673 
 
674 
Demographics and Military Service Characteristics Form:  The Demographics Form measures standard demographics 
675 
(race, gender, age) and military service information (e.g., rank).  This measure will be administered at the baseline 
676 
assessment. 
677 
 
678 
Life Events Checklist-5 (LEC-5). The LEC includes a list of 24 potentially traumatic life events commonly associated with 
679 
PTSD symptoms. The instrument was designed to facilitate the diagnosis of PTSD (Weathers, Blake, Schnurr, Kaloupek, 
680 
Marx, & Keane, 2013a).). In this study, the LEC-5 will also be used to identify the index event and focus of the PTSD 
681 
treatment. For each potentially traumatic life event, respondents rate their experience of that event on a 5-point nominal 
682 
scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 =part of my job, 5= not sure, and 6 = does not apply). 
683 
Each nominal point will be scored separately, as either 0 (=not endorsed by participant) or 1 (=endorsed by participant). 
684 
This measure will be administered at the baseline assessment, the one-month follow-up assessment, and the three-month 
685 
follow-up assessment. 
686 
 
687 
Deployment Risk and Resilience Inventory-2 (DRRI-2) Combat Experience and Post-battle -Scales: High- and low-
688 
intensity deployment stress exposure will be assessed using scales from the DRRI-2 (Vogt, Smith, King, & King, 2012). 
689 
The DRRI-2 is an update of the original DRRI (King, King, Vogt, Knight, & Samper, 2006), which was developed and 
690 
tested in three separate national samples of veterans of the first Gulf War. It has been revised and tested with 
691 
OEF/OIF/OND returnees (Vogt et al., 2008). The DRRI-2 provides an update of the DRRI’s assessment of deployment-
692 
related factors to ensure the instrument’s applicability across a variety of deployment circumstances (e.g., different eras of 
693 
service) and military subgroups (e.g., men and women), as well as to validate updated measures in a contemporary 
694 

 
Version 21 December 2020 
 
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Veteran cohort (Vogt, et al., 2012). High intensity stressor exposures will be assessed using the DRRI Combat 
695 
Experiences and Aftermath of Battle subscales. Responses to these scales are on a 6-point Likert scale. The total score 
696 
is the sum of the item scores, where higher scores signify greater exposure to combat or exposure to the consequences 
697 
of combat, respectively. Both subscales have very good internal consistency (α = .90 to .92) and construct validity (Vogt et 
698 
al., 2012). This measure will be administered at the baseline assessment. 
699 
 
700 
Mini-International Neuropsychiatric Interview (MINI-7.0) Psychosis and Mania modules. The MINI 7.0 is a short, structured 
701 
clinical diagnostic interview designed to cover the major psychiatric disorders in DSM-5 and ICD-10. It is widely used in 
702 
epidemiological studies and multi-site clinical trials. Responses to the interviewer’s questions are rated as either “yes” or “no.” 
703 
As is the case on the SCID, there are skip-outs, which saves time.  However, this means that the MINI cannot be used to 
704 
index the severity of a given psychiatric problem, only caseness. When there are many skip-outs, the MINI takes ~15 minutes 
705 
to administer. The MINI can be used to assess the full spectrum of psychiatric problems, or specific modules can be employed 
706 
(e.g., the schizophrenia module to rule out thought disorder). This measure will be administered at the baseline assessment.  
707 
 
708 
Health Questionnaire. The original Health Care Utilization (HCU) is a 16-item questionnaire developed in 2000 for Dr. Patricia 
709 
A. Resick’s NIH grant, “Cognitive Processes in PTSD: Treatment II.” The questionnaire was based on the 1999 Behavioral 
710 
Risk Factor Surveillance System. The version that will be administered as part of the STRONG STAR Consortium has been 
711 
modified to be of increased relevance to active-duty service personnel. The measure includes items regarding use of mental 
712 
health services, current psychiatric medication, past psychiatric medication, hospitalization, and outpatient medical services, 
713 
as well as items intended to assess changes in participants’ military status. Tobacco/nicotine use will also be queried. This 
714 
measure will be administered at the baseline assessment, the one-month follow-up assessment, and the three-month follow-
715 
up assessment.  
716 
 
717 
Health Questionnaire – Supplemental for SGB.  The Health Questionnaire – Supplemental for SGB is a 11-item self-report 
718 
measure that assesses health conditions that would exclude individuals from receiving a stellate ganglion block. Respondents 
719 
are asked to answer “yes” or “no” to each of the items. This measure was created specifically for this study and will be 
720 
administered at the baseline assessment.  
721 
 
722 
Self-Injurious Thoughts and Behaviors Interview (SITBI): The SITBI (Nock, Holmberg, Photos, & Michel, 2007) is a structured 
723 
interview assessing the presence, frequency, and characteristics of self-injurious and suicidal thoughts and behaviors. The 
724 
SITBI will be administered by an Independent Evaluator, who will instruct the participants to answer the questions based on 
725 
their entire lifetime of experience. The SITBI has shown high interrater reliability, test-retest reliability, and concurrent validity 
726 
(Nock et al., 2007). This measure will be administered at the baseline assessment, the one-month follow-up assessment, and 
727 
the three-month follow-up assessment.  
728 
 
729 
Depressive Symptoms Index-Suicidality Subscale (DSI-SS):  The DSI-SS (Metalsky & Joiner, 1997) will be used to assess 
730 
current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, 
731 
perceived control over ideation, and impulses for suicide. It is being used as a core measure in the Military Suicide Research 
732 
Consortium. Scores on each item range from 0 to 3, with higher scores reflecting greater severity of suicidal ideation. 
733 
Instructions will instruct the participants to respond based on the past two weeks. A systematic review of measures of suicidal 
734 
ideation and behaviors found that the DSI-SS had evidence of excellent internal consistency and concurrent validity 
735 
(Batterham et al., 2014).  This measure will be administered at the baseline assessment, the two interim assessments, the 
736 
one-month follow-up assessment, and the three-month follow-up assessment.  
737 
 
738 
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Weathers, Blake, Schnurr, Kaloupek, Marx, & Keane, 2012): 
739 
The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD (Weathers et al., 2013). Each item is rated on 
740 
a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity 
741 
for each of the 20 symptoms. Additional items that are not included in the total score evaluate overall symptom duration, 
742 
distress, impairment, dissociative symptoms, and global ratings by the interviewer. Validation studies are nearly complete to 
743 
establish the psychometric properties of the CAPS-5 and findings will be reported in peer-reviewed publications. This 
744 
interview is very similar to its predecessor, the CAPS for DSM-IV, which has been considered the gold standard for evaluating 
745 
PTSD and demonstrated good reliability and validity (Weathers, Keane, & Davidson, 2001). In addition to reflecting diagnostic 
746 
changes for PTSD in DSM-5, the CAPS-5 differs from the CAPS in that frequency and intensity ratings for each symptom are 
747 
no longer scored separately, so the severity rating for each item determines whether a symptom is present or not. Subscale 
748 
scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, 
749 
avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of 
750 
PTSD. This measure will be administered at the baseline assessment, the one-month follow-up assessment, and the three-
751 

 
Version 21 December 2020 
 
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month follow-up assessment.  
752 
 
753 
PTSD CheckList-5 (PCL-5): The PCL-5 (Weathers, et al., 2010) is a 20-item self-report measure update of the PCL designed 
754 
to assess PSTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good 
755 
psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past 
756 
week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific 
757 
life event.  Each item of the PCL-5 is scored on a five point scale ranging from 0 “not at all”) to 4 (“extremely). This measure 
758 
will be administered at the baseline assessment, the two interim assessments, the one-month follow-up assessment, and the 
759 
three-month follow-up assessment.  
760 
 
761 
Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a widely used and well-validated instrument for measuring the severity 
762 
of depressive symptoms (Kroenke, Spitzer, & Williams, 2001). It consists of 9 items that assess both affective and somatic 
763 
symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for DSM MDD. 
764 
Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a 
765 
scale ranging from 0 (“not at all”) to 3 (“nearly every day”). Scores on all items are summed to obtain a total severity score. 
766 
Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate depressive symptoms 
767 
(10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (>19). Respondents also 
768 
indicate the degree to which their depressive symptoms have made it difficult for them to do their work, take care of things at 
769 
home, or get along with other people, from “not difficult at all” to “extremely difficult.” The PHQ-9 has high internal consistency 
770 
(e.g., alpha ranging from .83 to .92; Cameron, Crawford, Lawton, & Reid, 2008), and correlates strongly with other measures 
771 
of depression (Kroenke et al., 2001).  This measure will be administered at the baseline assessment, the two interim 
772 
assessments, the one-month follow-up assessment, and the three-month follow-up assessment.  
773 
 
774 
Generalized Anxiety Disorder Screener (GAD-7): The GAD-7 (Spitzer, Kroenke, Williams, & Lowe, 2006) will be used to 
775 
assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with 
776 
which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 (“not at all”) to 
777 
3 (“nearly every day”). Scores on all items are summed to obtain a total severity score.  Scores reflect no significant 
778 
anxiety symptoms (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms (10-14), and severe anxiety symptoms 
779 
(>15).  Respondents also indicate the degree to which their anxious symptoms have made it difficult for them to do their 
780 
work, take care of things at home, or get along with other people, from “not difficult at all” to “extremely difficult.” The GAD-
781 
7 has been shown to have high internal consistency (e.g., α = .89; Lowe et al., 2008) and has been shown to reliably 
782 
discriminate between anxious and non-anxious diagnostic groups (Kroenke, Spitzer, Williams, & Lowe, 2010). 
783 
 
784 
Brief Inventory of Psychosocial Functioning: The Brief Inventory of Psychosocial Functioning (Marx et al. 2013) is a 7-item 
785 
self-report instrument measuring respondents’ level of functioning in seven life domains: romantic relationship, 
786 
relationship with children, family relationships, friendships and socializing, work, training and education, and activities of 
787 
daily living. Respondents indicate the degree to which they had trouble in the last 30 days in each area on a 7-point scale 
788 
ranging from “0 = Not at all” to “6 = Very much.” This measure will be administered at the baseline assessment, the one-
789 
month follow-up assessment, and the three-month follow-up assessment. 
790 
 
791 
Veterans Rand 12-Item Health Survey (VR-12): Because a certain level of PTSD symptoms is an occupational hazard 
792 
among service members redeployed for combat, it is critical to pay close attention to functional capacities as an important 
793 
index of intervention efficacy.  The Veterans SF-36 (VR-36) was adapted from the RAND SF-36 Version 1.0 
794 
questionnaire, and spans the range of health domains from physical to psychological health status. It includes two 
795 
modifications.  The first modification is an increase in the number of response choices for the role physical (RP) and role 
796 
emotional (RE) items from a  two point yes/no choice to a five-point likert scale (no, none of the time, yes, a little of the 
797 
time, yes, some of the time, yes, most of the time, yes, all of the time).  The second modification is the use of two items to 
798 
assess health change, one focusing on physical health and one on emotional problems, in contrast to the one general 
799 
change item in the RAND SF-36 (Kazis, Lee et al., 2004; Kazis, Miller, Clark et al 2004). The VR-36 has been widely 
800 
used, distributed and documented in the Veterans Health Administration (VHA) with close to 2 million questionnaires 
801 
administered nationally in six national surveys since 1996. The changes to the survey have increased the overall precision 
802 
of the instrument and the discriminant validity of the physical and mental component summary scales (Kazis, Nethercot, et 
803 
al 2006). The VR-36 is comprised of 37 items and eight scales:  physical functioning, role limitations due to physical 
804 
problems, bodily pain, general health perceptions, energy/ vitality, social functioning, role limitations due to emotional 
805 
problems, and mental health. Also, there are two summary scales:  a physical component summary (PCS) and mental 
806 
component summary (MCS). Higher scores indicate better health. Each summary is expressed as a T score, which 
807 
facilitates comparisons between the VA patients and the general U.S. population. The PCS and MCS scores provide at 
808 

 
Version 21 December 2020 
 
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least 90% of the reliable variance in the eight SF-36 concepts (Kazis & Wilson, 1998; Kazis, Wilson, et al., 1999). The 
809 
Veterans SF-12 was developed from the Veterans SF-36 and adapted from the MOS SF-36. It includes fewer items for 
810 
seven of the eight scales and provides 90% of the reliable variance in the two component summary measures using the 
811 
Veterans SF-36. Using independent results from the Veterans Health Study and the 1996 National Survey of Ambulatory 
812 
Care Patients, the results for the Veterans SF-12 corresponded very closely with the results for the Veterans SF-36 
813 
(average differences of 0.06 points between them for PCS and 0.31 points for MCS; Kazis et al., 1996; Kazis & Wilson, 
814 
1998). This measure will be administered at the baseline assessment, the one-month follow-up assessment, and the 
815 
three-month follow-up assessment.  
816 
 
817 
Alcohol Use Disorders Identification Test (AUDIT): The AUDIT (Babor et al, 2001) will be used to identify people with 
818 
hazardous or harmful patterns of alcohol consumption. The AUDIT is a 10-item screening measure, developed by the 
819 
World Health Organization (WHO), with three subscales (alcohol consumption, drinking behavior, and alcohol-related 
820 
problems) that are scored on a 4-point scale for a highest possible total score of 40. Among those identified as using 
821 
alcohol in a harmful manner, 92% had scores of 8 or more, though determining a cutoff score should be left up to the 
822 
clinician, depending upon the population being studied. The AUDIT has good internal consistency (α = .80-.93) as well as 
823 
sensitivity and specificity (Saunders, Aasland, Babor, De La Fuente & Grant, 1993). This measure will be administered at 
824 
the baseline assessment, the one-month follow-up assessment, and the three-month follow-up assessment. 
825 
 
826 
Insomnia Severity Index (ISI). The ISI (Morin, 1993) is a 7-item self-report measure that assesses perceived severity of 
827 
insomnia. Each item uses a 4-point Likert type scale from 0 (not at all satisfied) to 4 (very much satisfied). The items sum to 
828 
produce a total score (range 0 – 28). The ISI has an internal consistency alpha coefficient of 0.74, and has shown convergent 
829 
validity with other measures such as the Pittsburgh Sleep Quality Index (r = 0.67), the Dysfunctional Beliefs and Attitudes 
830 
about Sleep (r = 0.55), and sleep diaries (r ranges from 0.32-0.91) (Bastien, Vallieres & Morin, 2001). This measure will be 
831 
administered at the baseline assessment, the one-month follow-up assessment, and the three-month follow-up assessment.  
832 
 
833 
Posttraumatic Cognitions Inventory (PTCI):  The PTCI is a 36-item questionnaire that was developed to determine how an 
834 
individual views the trauma and its sequelae in an attempt to understand both how PTSD develops and is maintained (Foa, 
835 
Elhers, Clark, Tolin, & Orsillo, 1999).  Using an emotional processing theory, Foa and her colleagues (1999) have suggested 
836 
that PTSD is a consequence of disruptions in the normal processes of recovery when an individual has excessively rigid 
837 
concepts about self and world rendering the person vulnerable if a traumatic event occurs.  Thus the PTCI was developed as 
838 
a measure of trauma-related thoughts and beliefs.  It is comprised of three subscales (Negative Cognitions about the Self, 
839 
Negative Cognitions about the World, and Self-Blame).  The measure was tested in almost 600 adult volunteers recruited 
840 
from two university PTSD treatment clinics as well as a university community.  Approximately 65% (n=392) of individuals 
841 
reported having experienced a trauma in which their own life or that of another person was perceived to be in danger and their 
842 
response at the time included intense terror, horror, or helplessness (Criterion A event).  The remaining 35% (n=162) denied 
843 
such a traumatic experience.  Of those who had experienced a trauma, 170 had PTSD symptoms of at least moderate 
844 
severity while the remaining 185 reported a low symptom severity.  The three subscales of the PTCI demonstrated internal 
845 
consistency with alpha coefficients ranging from 0.86 to 0.97.  Convergent validity was demonstrated comparing the PTCI to 
846 
appropriate subscales of the World Assumptions Scale and Personal Beliefs and Reactions Scale.  Significant correlations 
847 
between the appropriate subscales ranged from 0.20 to 0.85.  The PTCI was able to differentiate individuals with and without 
848 
PTSD demonstrating discriminate validity (sensitivity = 0.78, specificity = 0.93).  Test–retest reliability for each of the three 
849 
subscales at a 1-week interval ranged from 0.75 to 0.89 and for a 3-week interval ranged from 0.80 to 0.86. This measure will 
850 
be administered at the baseline assessment, the two interim assessments, the one-month follow-up assessment, and the 
851 
three-month follow-up assessment.  
852 
 
853 
Credibility/ Expectancy Questionnaire (CEQ):  The CEQ is a 6-item measure that was designed to assess treatment 
854 
expectancy and rationale credibility for use in clinical outcomes studies (Devilly & Borkovec, 2000).  The credibility and 
855 
expectancy for the PE will be assessed separately from the credibility and expectancy for the stellate ganglion block.  It has 
856 
been expanded from a 5-item measure designed primarily to assess credibility (Borkovec & Nau, 1972), 4-items of which have 
857 
been used by both Foa and Resick (P.A. Resick, personal communication, February 22, 2010; E.A. Hembree, personal 
858 
communication, February 23, 2010; E. B. Foa, personal communication, February 25, 2010) with the name Expectancy of 
859 
Therapeutic Outcomes (ETO).  The 6-item CEQ assesses both whether the person cognitively understands how the therapy 
860 
works (credibility) as well as whether the person affectively believes that the therapy will work for them personally 
861 
(expectancy).  The 6-item CEQ has been tested in 217 individuals including 68 male Vietnam veterans and 58 female 
862 
spouses, 69 individuals diagnosed with general anxiety disorder who had received treatment, and 22 individuals who had 
863 
received either Cognitive Based Therapy (CBT) or Eye Movement Desensitization and Reprocessing (EMDR) for the 
864 
treatment of PTSD.  The scale demonstrated high internal consistency (alpha coefficients ranged from 0.84 to 0.85).   Test-
865 

 
Version 21 December 2020 
 
19-878H, Peterson, Form BB, 01-05-21, AMD                                                                               Page 18 of 18 
 
retest reliability over a one-week period was found to be 0.82 for expectancy and 0.75 for credibility.  The CEQ was able to 
866 
differentiate between two treatment rationales in one study, one with and one without an encompassing theory while 
867 
maintaining equivalence between three rationales in another study.  Responses to four questions are scored using a 9-point 
868 
Likert scale (1= not at all, 9= extremely).  Responses to two of the questions are scored using an 11-point Likert Scale (0% to 
869 
100%).  The combined responses are used to generate a score for credibility and another score for expectancy.  This 
870 
measure will be administered at the baseline assessment, the one-month follow-up assessment, and the three-month follow-
871 
up assessment.  
872