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The purpose of this study is to understand if we can improve the treatment for posttraumatic stress disorder (PTSD). We are looking into whether the combination of Stellate Ganglion Block (SGB) treatment and Cognitive Processing Therapy (CPT) can reduce symptoms of PTSD. CPT is a trauma-focused talk therapy that can help identify and challenge unhelpful trauma-related beliefs about oneself, others, and the world. It is known to be a highly effective talk therapy for PTSD. SGB treatment is a procedure involving an injection of local anesthetic into a bundle of nerves located in the neck that is part of the sympathetic nervous system which controls our body's response to stressful situations and blocks pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stellate Ganglion Block + Cognitive Processing Therapy | Active Comparator | Participants in this arm will receive two active Stellate Ganglion Block Injections, two weeks apart. After receiving the first injection, participants will complete 10 sessions of Cognitive Processing Therapy over the course of one week. |
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| Placebo Injection + Cognitive Processing Therapy | Sham Comparator | Participants in this arm will receive two placebo (saline) Injections, two weeks apart. After receiving the first injection, participants will complete 10 sessions of Cognitive Processing Therapy over the course of one week. |
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| Active Stellate Ganglion Block + Daily Symptom Monitoring | Placebo Comparator | Participants in this arm will receive two active Stellate Ganglion Block Injections, two weeks apart. After receiving the first injection, participants will complete 5 sessions of daily symptom monitoring with a member of study staff over the course of one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy | Behavioral | Cognitive Processing Therapy is a first-line, gold-standard psychotherapy intervention for the treatment of PTSD. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale for DSM-5 | A clinician rated assessment of PTSD | Baseline to 6 month follow up |
| PTSD Checklist for DSM-5 | A self-report measure of PTSD symptom severity | Baseline to 6 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Held, PhD | Contact | 312-942-1423 | philip_held@rush.edu | |
| Sarah Pridgen, MA | Contact | 312-563-0577 | sarah_pridgen@rush.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2025 | Nov 18, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2025 | Nov 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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.
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| Stellate Ganglion Block | Drug | Stellate Ganglion Blocks are an injection of local anesthetic into the stellate ganglion, a collection of nerves in the side of the neck. |
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