Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD: A Randomized Controlled Trial
Phase: EARLY_PHASE1
Conditions: PTSD
Sponsor: Rush University Medical Center

 
 
 
 
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Protocol Summary 
 
Title:  
Evaluating The Efficacy of Combined Cognitive Processing Therapy 
and Stellate Ganglion Blocks for PTSD: A Randomized Controlled 
Trial   
Date: 
October 6, 2025 
NCT number 
06570213 
Principal investigator: 
 
Philip Held, Ph.D., Department of Psychiatry and Behavioral 
Science 
Co-Investigator 
John Burns, Department of Psychiatry and Behavioral Science 
Asokumar Buvanendran, Department of Anesthesiology 
Sandeep Amin, Department of Anesthesiology-Clinical 
Robert McCarthy, Department of Anesthesiology 
Study Coordinator and 
Data Access Manager 
Sarah Pridgen, M.A., Department of Psychiatry and Behavioral 
Science  

 
 
 
 
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Project Overview 
Posttraumatic stress disorder (PTSD) affects approximately 23% of veterans and is 
associated with numerous negative mental health outcomes, including decreased quality of life, 
substantial impairments in work, home, and social functioning, increased risk of suicide, and 
poorer long-term physical health. Despite the existence of evidence-based treatments for PTSD, 
research has demonstrated that 14-50% of those receiving these gold-standard PTSD treatments 
either do not respond or exhibit a diminished treatment response. Consequently, there is a clear 
need to explore ways to improve existing treatment outcomes. Given the strong evidence 
supporting existing first-line treatments, such as Cognitive Processing Therapy (CPT), it is likely 
that augmenting these treatments with novel therapeutics that have shown promise in the treatment 
of other conditions can further enhance outcomes beyond each treatment alone. One such 
therapeutic is Stellate Ganglion Block (SGB), which has been safely used in the treatment of 
chronic pain and other conditions. SGB has recently been shown to be effective at reducing PTSD 
symptoms.  
The proposed project will systematically test whether combining CPT with SGB produces 
greater PTSD symptom reductions and functional improvements in the short- and longer-term up 
to 6-months follow-up compared to CPT (+Placebo) or SGB (+Daily Monitoring) alone.  
 
Scientific Review 
First-Line PTSD Treatments 
PTSD is a debilitating mental health condition that impacts approximately 23% of Veterans. 
Between 2001-2017, the average incidence rate of PTSD in the U.S. military was 7.88 per 1000 
service members, with a peak incident rate of 12.94. Moreover, PTSD is associated with high 
rates of comorbidity and high degrees of functional impairment, more so than any other mental 
health disorder. Untreated PTSD has been shown to lead to substantial impairments in work, 
home, and social functioning, increased risk of suicide, and poorer long-term physical health 
outcomes. 
The Veterans Administration and Department of Defense (VA/DoD) Clinical Practice 
Guidelines recommend CPT, among other interventions, as a first-line psychotherapeutic 
intervention for the treatment of PTSD. CPT can produce large PTSD symptom reductions. 
These PTSD symptom reductions are lasting and can be maintained for 10 years or more. CPT 
has been successfully used with a wide range of populations, including service members and 
Veterans. The primary mechanism of action in CPT is hypothesized to be a reduction in negative 
trauma-related cognition about oneself, others, and the world.    
While CPT is traditionally delivered weekly over 12 sessions, our research group and 
others have recently demonstrated that CPT can be successfully administered in as little as a 
single week. In our recently completed clinical trial we also demonstrated that 1-week massed 
CPT can be effectively delivered via telehealth. Completion rates for 1-week massed CPT were 
extremely high with 96% of participants completing the entire course of treatment, suggesting 
excellent feasibility. The results from the 1-week massed CPT trial suggest that 87% of study 
participants experienced clinically significant PTSD severity changes after the single week, with 

 
 
 
 
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the majority of participants experiencing clinically meaningful improvement in PTSD symptoms 
after the fourth session (i.e., after two days of treatment). Symptom reductions achieved 
throughout 1-week massed CPT were maintained at the 3-month follow-up. Importantly, 
participants found the extremely brief treatment helpful and reported that it helped them remain 
focused on the treatment and acquire the necessary skills to effectively manage their PTSD 
symptoms. We have also shown that the massed/daily delivery of CPT is feasible and effective at 
reducing PTSD symptom severity with gains maintained for at least 12 months.    
 
Non-Response to First-Line PTSD Treatments 
Despite the demonstrated effectiveness of first-line PTSD treatments, not all individuals 
who receive these treatments show a favorable response. Research has demonstrated that 14-50% 
of those receiving gold-standard first-line PTSD treatments either do not respond or exhibit a 
diminished treatment response. Other studies have suggested that approximately two-thirds of 
treatment completers continue to meet PTSD diagnostic criteria and therefore continue to be at 
risk for reduced work, home, and social functioning. Moreover, meta-analyses suggest that service 
members and Veterans are less responsive to first-line PTSD treatments compared to civilians. 
Based on these data, it can be expected that many service members and Veterans will retain their 
PTSD diagnosis following an initial course of a first-line PTSD treatment, highlighting the need 
to identify better treatment options.  
Stellate Ganglion Block May be a Promising Treatment Option 
The stellate ganglion (SG) is a collection of sympathetic nerves found at the level of the 
sixth and seventh cervical ganglion. The SG forms as a result of the fusion of the inferior cervical 
and first thoracic sympathetic ganglions. Clinical blockade of the SG is useful for a wide variety 
of diagnostic and therapeutic indications and is becoming a well-researched and well-established 
treatment for a variety of physical health concerns, including chronic pain. SGB has recently been 
shown to also be effective for reducing PTSD symptom severity. SGB is a treatment that involves 
an injection of local anesthetic around the stellate ganglion (located at the base of the neck) to 
block its transmission of pain signals.  
A recent sham-controlled randomized clinical trial suggested that SGB produces 
significantly greater PTSD symptom reductions compared to saline injections. Similarly, case 
series studies and reviews support the safety and effectiveness of SGB in reducing PTSD 
symptoms. Studies have indicated that SGB’s impact can last over time, although there is a clear 
need for studies that examine treatment effects for more than three months. SGB has been 
determined to be safe and is particularly well-received by military populations. 
Research suggests that SGB may be particularly effective at reducing hyperarousal 
symptoms. This is particularly important because first-line psychotherapies have been shown to 
have a limited impact on hyperarousal symptoms. Combining CPT and SGB may therefore 
enhance the efficacy compared to each treatment used as a standalone intervention and provide a 
relief with common residual symptoms, such as irritability or angry outbursts, difficulty 
concentrating, and sleep disturbance. 
Individuals with PTSD most notably reported significant enhancements in the initial week 
following the SGB procedure. This immediate post-procedural period might serve as an opportune 

 
 
 
 
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time to initiate trauma-focused psychotherapy. The initial symptom alleviation resulting from SGB 
could enhance individuals’ receptivity to interventions like CPT. This heightened engagement, 
stemming from symptom reduction, might further catalyze cognitive and behavioral shifts in 
individuals. Such transformations could not only amplify the therapeutic outcomes beyond those 
achieved by standalone treatments but also ensure the longevity of these benefits. 
Complementary Treatment Mechanisms 
CPT and SGB are hypothesized to operate via distinct mechanisms that may complement 
one another in the treatment of PTSD. CPT is a primarily cognitive intervention that teaches 
individuals to identify negative posttrauma cognitions about the cause of the traumatic event (i.e., 
“It was my fault,” “If only I had done something differently the event wouldn’t have happened,” 
“If people had done their jobs, everyone would have survived”), as well as overgeneralized beliefs 
stemming from the trauma about themselves, others, and the world (i.e., “The world is unsafe,” “I 
can’t trust anyone,” “I am damaged”) and identify related emotions. These distorted beliefs are 
thought to fuel trauma-related symptoms and functional impairment.  
The mechanism by which SGB exerts therapeutic effects in PTSD, on the other hand, is 
postulated to primarily revolve around the modulation of the sympathetic nervous system. The SG, 
located at the juncture of the cervical and upper thoracic vertebrae, serves as a critical nexus in 
sympathetic innervation, influencing various physiological functions. Upon administering SGB, a 
local anesthetic is delivered around the SG leading to an effective interruption of sympathetic 
outflow. This intervention is theorized to induce a subsequent reduction in overall sympathetic 
tone, diminishing the heightened state of arousal characteristic of PTSD. Beyond simple 
sympathetic downregulation, emerging research highlights potential neurochemical alterations 
secondary to SGB. Particularly, there may be modifications in neurotransmitter dynamics, with 
norepinephrine—a key sympathetic neurotransmitter that's often dysregulated in PTSD—being of 
primary interest. By modulating sympathetic activity, SGB might catalyze a more adaptive form 
of neural plasticity, enabling neural circuits to reorient towards a more normalized state 
associated with fewer PTSD symptoms. 
The Importance of Testing Combined CPT and SGB 
Taken together, evidence points to the ability of CPT and SGB to reduce the severity of 
PTSD symptoms in short periods via two distinct psychological (i.e., changes in trauma-related 
cognitions) and biological (i.e., sympathetic/parasympathetic balance) mechanisms. However, no 
studies to date have systematically examined whether combining these two interventions produces 
larger effects than each intervention alone. Consequently, there is a critical need to examine CPT 
and SGB in combination to determine whether this could have a positive impact on overall PTSD 
treatment response rates. Since both treatments are widely available, finding support for the 
hypothesis that CPT+SGB produces stronger outcomes than each treatment alone could result in 
rapid dissemination which may help a greater number of service members and Veterans experience 
larger improvements compared to each treatment alone as is the case in current practice.  
Measuring Physical Health Improvements via Heart Rate Variability 

 
 
 
 
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SGB is theorized to exert a direct influence on the autonomic nervous system, 
predominantly through tempering the sympathetic nervous system's activity. The equilibrium 
between the sympathetic and parasympathetic arms of the autonomic nervous system is 
represented by a metric known as heart rate variability (HRV. HRV refers to the variation in time 
intervals between consecutive heartbeats. In essence, a higher HRV signifies greater adaptability 
and resilience of the heart, indicative of a harmonious balance between sympathetic and 
parasympathetic inputs. Numerous studies have unequivocally associated enhanced HRV with 
robust cardiovascular health, augmented physical stamina, and optimal physiological functioning. 
Moreover, lower HRV has been correlated with an array of adverse health outcomes, including 
increased susceptibility to cardiovascular disease and reduced life expectancy. 
Despite the established connection between HRV and overall health as well as PTSD, there 
remains a paucity of research dissecting the direct influence of evidence-based psychotherapies 
(EBPs) for PTSD on HRV or broader physical health parameters. Evidence-based psychotherapies 
such as CPT have been predominantly investigated concerning their therapeutic efficacy on 
psychological parameters, with less emphasis on physiological outcomes. Therefore, it is 
paramount to discern if such psychotherapies can directly ameliorate physical health or if their 
positive repercussions on health are predominantly mediated by reductions in PTSD 
symptomatology.  
 
Research Plan 
Objectives  
To systematically address questions surrounding improving PTSD treatment, the proposed 
3-arm randomized controlled clinical trial will directly compare the combination of CPT+SGB vs. 
CPT (+Placebo) vs. SGB (+daily monitoring) in a total of 180 service members, Veterans, and 
civilians with PTSD. Short- and longer-term (up to 6-month follow-up) impacts of the respective 
interventions on both PTSD symptoms and functioning will also be assessed.    
Objective 1  
Determine the efficacy of combining CPT and SGB for reducing PTSD symptoms and 
improving functioning. H1a: Participants who receive CPT+SGB will experience greater 
reductions in PTSD symptoms based on clinician-administered and self-reported PTSD 
assessments and greater improvements in functioning compared to each intervention alone. H1b: 
Clinician-administered and self-reported PTSD symptoms will reduce to a greater extent 
immediately after and 3- and 6-months following treatment for participants assigned to the 
CPT+SGB condition vs. those who receive CPT (+Placebo) and SGB (+daily monitoring).   
Objective 2  
Probe changes in negative posttrauma cognitions and sympathetic/parasympathetic balance 
as potential complementary treatment mechanisms. H2a: Negative posttrauma cognitions will 
improve over the course of CPT+SGB and CPT and improve to a greater extent than for individuals 
who receive SGB. H2b: Greater reduction in the sympathetic/parasympathetic balance, assessed 
via heart rate variability (HRV), will be experienced by individuals assigned to the CPT+SGB and 
SGB conditions compared to individuals who receive CPT. H2c: Changed in negative posttrauma 

 
 
 
 
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cognitions and sympathetic/parasympathetic balance will predict short- and longer-term (6-month) 
PTSD symptom reductions and functional improvement. 
Secondary Objectives  
The study is also designed to examine the effects of each treatment on physical well-
being, as assessed via heart rate variability (HRV), which has been closely linked to long-term 
physical health.    
 
Target Population and Sample Size 
We will consent and enroll a total of approximately 180 service members, veterans, and 
civilians with PTSD. Based on our prior trials with this population, we anticipate that ~25-50% of 
potential participants will not meet inclusion criteria or will not start treatment. Thus, we plan to 
recruit 270 individuals to have a final sample of 180 service members, veterans, and civilians who 
start treatment. We will purposely oversample for veterans and service members with the goal of 
recruiting approximately n = 90 veterans and/or service members and approximately n = 90 
civilians for the final sample.  
 
Study Timelines 
For participants, this study is expected to take 7.5 months to complete. Based on our 
experiences with a recent SGB pilot study, we anticipate the screening, intake, and treatment 
scheduling process to take approximately 1 month to complete. The treatment process is 
expected to take two weeks to complete. The remaining six month duration of the study will be 
spent completing follow-ups, which will occur up to six months following participants’ second 
SGB/placebo saline injection.  
 
Inclusion and Exclusion Criteria 
Individuals are eligible for the current study if they: 
1. Are 18 years or older 
2. Are fluent in English 
3. Have experienced a Criterion A traumatic event during their lifetime 
4. Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5 
5. Have not previously received an SGB 
6. Have a smartphone that they can use for the entire duration of the study 
7. Are willing and able to receive 2 injections (SGB or placebo) 2 weeks apart at the Rush Pain 
Clinic 
8. Are willing and able to participate in daily CPT or Daily Monitoring over the course of one 
week 
9. Are willing and able to complete self-report measures and clinician-rated assessments at 
multiple time points over the course of the study 
 
Individuals are excluded from the current study if: 
1. The traumatic event occurred in the past month 

 
 
 
 
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2. They are currently suicidal or homicidal (i.e., plan and intent) 
3. They have unmanaged psychosis or mania 
4. They have not been on a stable dose of psychotropic medication for at least one month by the 
time of the baseline assessment or are planning to change their medications within 3 months 
of starting their participation in the study 
5. They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., CPT or 
Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD 
treatment 
6. They have an intellectual disability or significant cognitive impairment that would prevent 
them from engaging fully in treatment 
7. They are currently on any blood-thinning medications or have a coagulopathy 
8. They have any of the following conditions: a recent myocardial infarction, glaucoma, a pre-
existing contralateral nerve palsy, severe emphysema, or a cardiac conduction blockade. 
9. They are allergic to any of the medications injected (i.e., ropivacaine, lidocaine, propofol) 
10. They have an active infection 
11. They have a serious or unstable medical illness or instability for which hospitalization may be 
likely within the next year 
12. They have a visual or auditory impairment that would prevent them from fully participating in 
study activities 
13. They are involved with current legal actions related to the traumatic event that is anticipated 
to be targeted during treatment 
14. They have substance dependence that, in the judgment of the Principal Investigator, may 
require hospitalization if substances were discontinued. 
15. Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., 
unstable housing, no internet access, etc.) which, in the judgment of the Principal Investigator, 
could affect the ability to deliver the intervention with fidelity 
These inclusion criteria are as broad as possible to allow for the trial to apply to real-world 
clinical settings. The exclusion criteria were chosen to identify individuals that have certain 
comorbidities or circumstances that would make engagement in a cognitive-based treatment 
difficult or potentially interfere with a clinician’s ability to deliver the intervention with fidelity. 
The exclusion criteria chosen would be considered as a part of standard clinical care outside of a 
research setting for those seeking CPT or SGB treatment for PTSD. 
 
Study Activities 
Eligibility Phone Screening 
Individuals who are interested in participating in the proposed study will call study staff 
in response to study recruitment flyers or will be called by the study staff once they have been 
referred. The eligibility screening will be conducted over the phone. Interested individuals will 
be asked for their verbal consent to participate in the eligibility screening and then screened to 
determine potential eligibility. Individuals who meet exclusion criteria during the screening or 

 
 
 
 
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virtual baseline visit or who choose not to participate will be referred for other 
treatment/resources as indicated. Potentially eligible individuals will be sent the electronic 
consent form.  
 
Informed Consent 
Informed consent will be obtained by trained members of the study staff before the baseline 
assessment. Potential participants will be emailed the electronic consent form via REDCap, a 
HIPAA-secure platform. Study staff will call and explain the study to the potential participants 
and answer any questions they have. Potential participants will be encouraged to carefully read the 
entire consent form and to take their time to consider if they would like to participate. Potential 
participants can take as much time as they need to decide if they would like to participate and reach 
out to study staff with any questions they may have. Potential participants will be allowed to 
discuss the study with others (e.g., an outside treatment provider) if they would like to before 
consenting.  
If at any time reconsent is needed, participants will be sent a new electronic consent form 
via REDCap and study staff will inform them of any changes that were made.  
 
Virtual Baseline Assessments  
Under the supervision of the Principal Investigator, who is a licensed clinical 
psychologist, trained study staff, with at least a Bachelor’s degree and who are not providing the 
treatment, will conduct structured diagnostic interviews. These interviews are to determine 
eligibility by confirming a diagnosis of PTSD, as assessed by a gold-standard Clinician 
Administered PTSD Scale for DSM-5. Completion of the baseline assessment will take 
approximately 4 hours and may take place over 1-2 days, depending on the participant’s 
availability. The baseline assessment will be conducted virtually via the HIPAA-compliant 
telehealth platform Microsoft Teams. All baseline assessments will be audio/video recorded for 
research purposes and to ensure that assessments were delivered with fidelity. 
Study staff will also securely email the full self-report assessment battery to intake 
participants via REDCap, which takes approximately 40 minutes to complete.  Individuals who 
meet exclusion criteria during the virtual baseline visit or who choose not to participate will be 
referred for other treatment/resources as indicated.   
 
Setting Up Wearable Device 
If eligible for the study following baseline assessments, participants will be mailed a 
wearable sensor device called a Fitbit to wear on their wrists to measure metrics commonly 
collected by Fitbit devices (e.g., heart rate variability, heart rate, steps, calories). Participants will 
be asked to wear the Fitbit between baseline and the six-month follow-up. Following the six-
month follow-up, participants will be asked to return the Fitbit device through the mail. Study 
staff will provide pre-paid shipping labels and shipping instructions at no cost to participants. 
Participants will not be charged for damaging or failing to return their assigned devices.  
 
Random Assignment of Treatments 

 
 
 
 
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Random assignment of eligible participants will occur in two steps using a custom 
computer randomization algorithm. First, participants will be randomly assigned to receive either 
two active SGB injections or two placebo saline injections. In the second stage of random 
assignment, participants will be randomly assigned to receive 1-week of CPT or daily symptom 
monitoring.  
 
As there will only be three treatment conditions of this study (SGB+CPT, SGB+Daily 
Monitoring, and Placebo Injection+CPT), individuals that are randomly assigned to the placebo 
injection group in the first stage of random assignment will automatically be assigned to receive 
CPT.  
Stellate Ganglion Block or Placebo Saline Injections 
Depending on which group eligible participants are assigned to, they will either receive 
an active SGB injection or a placebo saline injection on two separate occasions, with the first 
occasion occurring before the start of CPT session one and the second occasion occurring two 
weeks after the first injection. Appointments will take approximately 60 minutes.  
 Ultrasound-guided SGBs will be performed in the Rush Pain Center by anesthesiologists 
(AB, SA) who are fellowship-trained in pain management and the use of ultrasound-guided 
nerve blocks. Participants will be brought to the Rush Pain Center procedure room by a medical 
assistant who will attach ECG, non-invasive blood pressure, oxygen saturation, and respiratory 
monitors. Participants will then be allowed to acclimate to the room for 10 minutes. Participants 
will be moved to a supine position and an IV catheter will be placed. A nasal cannula will be 
placed in their arm and oxygen will be delivered at a rate of 2 L/min. The anesthesiologists will 
discuss the procedure with the participant. An ultrasound system will be used to view the 
anatomy of their neck and needle position. Participants will be placed lying down.  
For the active SGB procedure, after aseptic preparation of the skin, and localization of the 
skin with 1% lidocaine, the transducer will be placed on the neck. 7 mL of bupivacaine (0.5%) 
will be injected around and into the site of the SG The injection and spread (including 
longitudinal spread) of local anesthetic will be visualized in real-time. For the placebo saline 
injection condition, the same procedure will occur, but participants will be injected with 7 mL of 
saline subcutaneously rather than bupivacaine at the site of the SG.    
 
Virtual CPT or Daily Symptom Monitoring  
 
Between the first and second SGB or placebo saline injection, one-week of virtual 
massed CPT or daily monitoring will take place.  
CPT. Eligible participants so randomly assigned will undergo a course of 1-week-long 
massed CPT. Massed CPT will be delivered twice per day over five business days (Monday 
through Friday; 10 sessions total) via the HIPAA-compliant platform Microsoft Teams. Each 50-
minute session will closely follow the CPT protocol and will be conducted by a Master’s level or 
higher clinician under the supervision of the principal investigator (PI), who is a licensed clinical 
psychologist and a certified CPT provider. Participants will not be billed for their CPT sessions. 
Daily Monitoring. A daily monitoring condition will be used as a psychotherapy placebo 
in this study. Participants will have daily appointments with study staff. Study staff will be 

 
 
 
 
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trained on how to identify and manage potential distress and will be supervised by the PI. Like at 
the beginning of each CPT session, participants in the monitoring condition will review their 
assessments and symptom scores. Study staff will ask participants about the extent to which their 
assessment scores match their current symptoms, as well as whether participants noticed any 
changes in their symptoms since the beginning of the study or since the last monitoring session. 
Study staff will use reflective listening and verbal and non-verbal encouragers but will not use 
any cognitive behavioral interventions with participants as part of this study condition. 
Participants will only have one daily monitoring appointment per day for five consecutive days, 
since measures are only administered once per day during the week. Each session will last 
approximately 15-30 minutes. 
Assessments During Treatment. Both the CPT and Daily Monitoring groups will 
receive the same daily surveys. These daily surveys will assess PTSD and depression severity 
and will be administered electronically via REDCap. The completion of these measures takes 
approximately 10-15 minutes per administration and will be reviewed by study staff. 
 
Virtual Follow-Up Assessments   
Participants will be asked to complete self-report measures assessing their PTSD 
symptoms. Follow-up dates will be calculated based on the date of the second SGB/placebo 
injection. At the 1-week, as well as the 1-, 3-, and 6-month follow-ups, participants will be asked 
to participate in virtual structured follow-up assessments that contain the same measures as the 
virtual baseline assessment. These assessments are intended to assess symptom change 
throughout the study. Completion of follow-up measures may take approximately 30 minutes for 
self-report measures and 2 hours for clinician-administered assessments. Following an intent-to-
treat design, study staff will make efforts to obtain assessments from all individuals, including 
those who chose to discontinue treatment as long as participants received at least 1 SGB/placebo 
treatment and had at least 2 CPT sessions. Participants will be informed about which condition 
they were assigned to following the completion of their 6-month follow-up assessment.  
 
Treatment Fidelity Ratings 
All daily monitoring and CPT sessions will be audio and/or video recorded and an 
independent fidelity rater with experience in the treatment, who will be a member of the study 
staff, will randomly select and review 20% of all therapy audio recordings. This process will 
help ensure that the intervention is provided with fidelity, which will be defined as 80% or more 
of the maximum possible score on the rating scales. CPT worksheets and homework assignments 
may be collected and stored for research purposes. Individuals will complete electronic versions 
of CPT worksheets and upload them to a secure folder accessible only by the individual and 
study staff. 
 
Measures  
Self-report measures and clinician-rated assessments will be used during the study. The 
assessment schedule below details the different assessment time points for each measure. 

 
 
 
 
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Measures may also be administered as needed at clinically relevant intervals. At each follow-up 
timepoint participants will be asked about any outside psychotherapeutic or medical treatment 
they have received since starting the study. 
 
Assessment Grid 
Life Events Checklist (LEC); Colombia Suicide Severity Rating Scale (C-SSRS); 
Clinician- Administered PTSD Scale for DSM-5 – Revised (CAPS-5-R); Structured Clinical 
Interview for the DSM-5 (SCID-5); Posttraumatic Stress Disorder Checklist for DSM‐5 (PCL‐5); 
Patient Health Questionnaire (PHQ-9); Generalized Anxiety Disorder 7-item Scale (GAD-7); 
Alcohol Use Disorders Identification Test (AUDIT); Drug Abuse Screening Test (DAST-10); 
Posttraumatic Cognitions Inventory (PTCI); Heart Rate Variability (HRV); Life Functioning 
Questionnaire (LFQ); World Health Organization Quality-of-Life Scale (WHOQOL-BREF); 
World Health Organization Disability Assessment Schedule Version 2 (WHODAS 2.0) 
 
 
 
Baseline During CPT 
or Daily 
Monitoring 
1-Wk FU 
1-Mo FU 
3-Mo FU 
6-Mo FU 
Demographics 
X 
 
 
 
 
 
LEC-5 
X 
 
 
 
 
 
C-SSRS 
X 
 
X 
X 
X 
X 
CAPS-5-R 
X 
 
X 
X 
X 
X 
SCID-5 
X 
 
X 
X 
X 
X 
PCL-5 
X 
X 
X 
X 
X 
X 
PHQ-9 
X 
X 
X 
X 
X 
X 
GAD-7 
X 
 
X 
X 
X 
X 
AUDIT 
X 
 
X 
X 
X 
X 
DAST-10 
X 
 
X 
X 
X 
X 
PTCI 
X 
 
X 
X 
X 
X 
Fitbit Sensor 
Data  
X 
X 
X 
X 
X 
X 
LFQ 
X 
 
 
X 
X 
X 
WHOQOL-
BREF 
X 
 
X 
X 
X 
X 
WHODAS 2.0 
X 
 
X 
X 
X 
X 
Session 
Attendance 
 
X 
 
 
 
 
Session 
Completion 
 
X 
 
 
 
 
Adverse Event 
 
X 
X 
X 
X 
X 

 
 
 
 
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Satisfaction 
 
 
 
 
X 
X 
 
Recruitment Methods 
Participants will be recruited through the Road Home Program: Center for Veterans and 
Their Families at Rush University Medical Center and its referral partners such as the Wounded 
Warrior Project and Warrior Care Network. Participants will also be recruited via Facebook ads, 
fliers, and word-of-mouth at local VA Medical Centers, of which there are three in the 
Chicagoland area alone. The Road Home Program has strong relationships with these VAs and 
frequently receives direct referrals for massed PTSD treatment. We will utilize the teams’ 
relationships with different local and national VA leaders to disseminate information about the 
proposed project to enhance recruitment. In addition, our team has extensive experience 
recruiting for PTSD treatment trials in civilian populations using phone-based “on hold” 
advertising and social media advertisements.  
To complement these recruitment strategies, we will also be engaging a clinical trial 
recruitment firm (e.g., TrialFacts). The recruitment success will be evaluated on an ongoing 
(quarterly) basis. Changes to the recruitment strategies will be discussed among the study team 
should problems be encountered.   
 
Compensation for Participation  
Participants will be compensated for the completion of study-related assessments in the 
form of Amazon electronic gift cards emailed to participants. Participants will be compensated 
up to $330 for completion of all study tasks, which breaks down to $40 for the baseline 
assessment, $40 for the 1-week follow-up, $50 for the 1-month, $100 for the 3-month, and $100 
for the 6-month follow-up assessments.  
In compliance with federal regulations, service members and federal civilian employees 
cannot be compensated for completing study procedures while on active duty.  
Participants will not be compensated for the treatment they receive or the daily surveys, 
which are part of measurement-based care and considered a part of treatment.  
 
Baseline 
1-Week 
Follow-Up 
1-Month 
Follow-Up 
3-month 
Follow-Up 
6-month 
Follow-Up 
$40 
$40 
$50 
$100 
$100 
 
 
 
 
Total: $330 
 
Costs to Participants 
There will be no direct cost to participants to participate in this study. All clinical, 
professional, diagnostic and laboratory services related to the study will be provided at no cost to 
participants. There will be no medication costs to participate; medication (SGB medication or 
placebo saline injection) will be provided to the participants at no cost. However, participants 
will be responsible for their phone service provider’s standard charges as they apply to any 
study-related phone calls and internet usage. They will also be responsible for any costs related 
to transportation to and from the Pain Clinic, including parking.  

 
 
 
 
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Risks to Participants 
There are risks associated with the SGB procedure as well as with CPT and Daily 
Monitoring; these risks are outweighed by the potential benefits of this study.  
 
Risks Associated with SGB 
SGB injections are typically well-tolerated but can be associated with risks. Potential 
serious complications associated with the SGB procedure include vascular puncture, neural 
puncture, pneumothorax, thyroid injury, esophageal and/or tracheal puncture, and intravascular 
injection, neuraxial, phrenic nerve or brachial plexus spread of local anesthetic, and infection.  
Other common risks following SGB treatment are bruising or soreness at the injection site, 
nasal stuffiness, hoarse voice, feeling a “lump” in the throat, and difficulty in swallowing. A 
transient but potentially troubling common complication of an SGB is an ipsilateral Horner 
syndrome (ptosis, miosis, enophthalmos, facial anhidrosis, and conjunctival injection) These mild 
symptoms are short-lived and in almost all cases resolve within hours. Although Horner’s 
syndrome occurred in 70% of the subjects in one SGB study by McLean, it did not appear to impact 
the patients’ decision regarding acceptance or willingness to repeat the procedure. Participants 
may experience hoarseness which should disappear within 4-6 hours. Overall, they found that 
100% of the patients were satisfied with the SGB and were willing to undergo repeated procedures 
as necessary 
In a randomized controlled trial of 74 patients that underwent SGBs, only 3 (2%) reported 
adverse events. None of the complications were serious and included temporary laryngeal 
irritation, pain at the injection site, and a brief self-reported bradycardia. There has been no 
reported incidence of a severe adverse drug reaction to the study treatment in any published 
literature examining SGBs for PTSD. 
 
Risks Associated with CPT and Daily Monitoring 
CPT is an existing evidence-based treatment for PTSD that has been shown to be both 
effective and safe. Some individuals experience temporary emotional distress when discussing 
their traumatic experiences. This distress is usually temporary and subsides after the discussion of 
the trauma concludes. Daily Monitoring has been safely used as an active control condition in 
various research trials and has been shown to reduce distress. To date, no adverse events have been 
associated with CPT or Daily Monitoring in either massed or spaced formats, suggesting both are 
tolerable.  
 
Management of Risk 
The risk for serious complications associated with a SGB procedure will be managed 
through the use of ultrasound guidance. When placed using ultrasound guidance, SGB has been 
shown to have a high safety profile. Subjects will be asked to refrain from eating from midnight 
the night before the procedure and only be allowed sips of water the morning of the procedure. 
Subjects will be instructed not to drive or operate heavy machinery for 24 hours after the 

 
 
 
 
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procedure. Subjects will be instructed not to eat food or drink for four hours after the procedure or 
until their ability to swallow as normal has returned. If the study physician deems the risks 
associated with the SGB treatment to be too severe for the participant, the study physician may, in 
correspondence with the PI, remove the participant from the study.  
Participants may experience distress during CPT treatment or Daily Monitoring. 
Participants’ suicidality will be assessed by the treating clinicians on an ongoing basis and 
assessed formally at the baseline as well as each follow-up time point using the Columbia 
Suicide Severity Rating Scale (C-SSRS). If a participant indicates having “Thoughts that [they] 
would be better off dead or of hurting [themselves] in some way” more than half the days (2) or 
nearly every day (3), the study clinician will conduct a safety assessment. If any participant 
becomes actively suicidal with intent, the study clinician will refer the participant to a higher 
level of care (i.e., psychiatric, medical, or emergency services).  
All treatment sessions/visits will take place during regular business hours; in the case of a 
crisis during treatment or a virtual assessment, the study clinician will be available to assist or 
instruct the participant to call 911 or go to their nearest emergency room. Participants will be 
responsible for the cost of such care. Prior to the start of any telephone/video session, the 
provider will inquire about the current location to have this information in case of an emergency. 
In addition, we will obtain the number of a person whom they trust at the beginning of treatment 
who lives nearby (i.e., 20-minute drive max). Participants can agree that we call these individuals 
to check on the participants when needed before we ask the local police department to conduct a 
wellness check. Individuals will no longer be able to continue this course of CPT or Daily 
Monitoring if they are actively suicidal but may be able to enroll at a later time after reaching 
stability per eligibility requirements.  
The risk of loss of confidentiality, although unlikely, is possible. All study staff will work 
diligently to ensure that all data is stored securely and that study-related files are password 
protected so that only members of the study staff will have access to identifiable data. To protect 
confidentiality, each subject is assigned a unique code. Only study personnel will be able to link 
a patient’s name to the identification number. All telephone/video sessions will be conducted 
using a HIPAA-compliant platform, Microsoft Teams. In addition, a Certificate of 
Confidentiality has been obtained. No identifiable data will ever be disclosed to any outside 
parties, except where required by law. De-identified data may be reported in aggregate for 
internal clinical use, publications, or other presentations. 
A Certificate of Confidentiality has been obtained as part of this study. This Certificate 
means that researchers cannot be forced, even by courts or the police, to disclose any information 
about participants. The Certificate does not stop participants from disclosing, or agreeing in writing 
to allow researchers to disclose, information about them. The researchers may not disclose or use 
any information, documents, or specimens that could identify participants in any civil, criminal, 
administrative, legislative, or other legal proceeding, unless participants consent to it. Information, 

 
 
 
 
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documents, or specimens protected by the Certificate of Confidentiality may be disclosed to 
someone who is not connected with the research if:  
1. There is a federal, state, or local law that requires disclosure (such as to report child abuse 
or communicable diseases);  
2. They consent to the disclosure, including for medical treatment;  
3. It is used for other scientific research in a way that is allowed by the federal regulations 
that protect research participants;  
4. A governmental or funding agency requests it for auditing or program evaluation purposes. 
If a participant discloses actual or suspected abuse, neglect, or exploitation of a child, or 
disabled or elderly adult, the researcher or any member of the study staff must, and will, report 
this to Child Protective Services (such as the Department of Family and Human Services), Adult 
Protective Services, and/or the nearest law enforcement agency. 
 
 
Potential Benefits to Participants 
Participants in this study may experience direct benefits. CPT has been shown to be 
effective for the treatment of PTSD. Thus, participants in this study may experience substantial 
reductions in their PTSD symptoms (as well as other comorbid mental health conditions). 
Together, these improvements can result in improved quality of life by being able to re-engage in 
daily functions.  
The knowledge gained from this project may improve our understanding of the 
mechanisms underlying successful PTSD treatments, potentially informing the development of 
more targeted and effective therapeutic strategies for individuals with PTSD. One contribution 
toward that goal is studying the effectiveness of a novel PTSD treatment (SGB), which may reduce 
symptom severity and improve life functioning. The knowledge gained from this project is also 
important because it can be used to inform VA and DOD clinical practice guidelines regarding the 
use of SGB and massed CPT.  
 
 
Data Storage 
Specify the site at which the data will be stored and how it will be stored: Audio 
recordings, video recordings, copies/scans of CPT session materials, and all electronic data 
collected through REDCap-delivered self-report assessments will be de-identified, password-
protected, and stored in a restricted folder within the RUMC secure network infrastructure. 
Telephone/video visit audio and video recordings from the HIPAA compliant telephone/video 
platform will be uploaded to the secure server within one business day and will be deleted from 
the platform immediately upon upload. CPT worksheets electronically uploaded to the secure 
folder accessible only to the participant and study staff will be deleted from this folder following 
the participant’s final study visit. Copies of the worksheets will be saved to a separate restricted 
study folder on the RUMC network infrastructure. When personally identifying data cannot be 

 
 
 
 
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removed (as may be the case with audio or video files), they will be provided with a unique de-
identified code and stored in a separate and secure network location. 
 
How long will the data be maintained and/or stored? All electronic data collected will be stored 
for least 5 years after the completion of the study. Once all analyses have been conducted after at 
least 5 years, all data will be securely deleted from the secure, password-protected file and 
system. Who, other than the specified study team, will have access to the study records or data? 
Specify their name, role, and affiliation. The principal investigator will monitor all access to 
data. Only study staff listed on and approved by the IRB will have access to the data for research 
purposes. Audio and/or video recordings may be shared with approved external collaborators for 
analysis through encrypted software shared on a secure web-based storage site. Participants in 
audio and/or video recordings will be identified by coded subject IDs. 
 
Justify your needs to collect PHI in this study: PHI will be collected in order to characterize the 
participant sample and to maintain contact with participants throughout the study, deliver 
assessments, and document the treatment progress. Audio and video recordings may also contain 
PHI that can potentially identify respondents. As PHI cannot be removed from audio and video 
files, these files will be provided with de-identified codes and stored in a separate and secure 
network location. 
 
Describe how and where PHI will be destroyed following the completion of the study: Not 
applicable. No identifiable data will ever be shared by the study team with personnel outside of 
the approved study staff. Any data shared with other researchers will be de-identified. All the 
findings in this study will be de-identified or reported at a group level or in aggregate with no 
risk of identifying individual participants. Will subjects be able to request that their information 
be removed from the data bank? Yes. However, it may not be possible to withdraw or delete 
materials or data in the event that they have already been shared with other researchers.