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RECRUITINGPhase 2INTERVENTIONAL

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Active duty and retired military service members ages 18-65 years 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale 3. Able to speak and read English (due to standardization of outcome measures) 4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed. Who Should NOT Join This Trial: 1. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider. 2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment) 3. Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment. 4. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment 5. Pregnancy or breastfeeding 6. Current anticoagulant use 7. History of bleeding disorder 8. Infection or mass at injection site 9. Myocardial infarction within 6 months of procedure 10. Pathologic bradycardia or irregularities of heart rate or rhythm 11. Symptomatic hypotension 12. Phrenic or laryngeal nerve palsy 13. History of glaucoma 14. Uncontrolled seizure disorder 15. History of allergy to local anesthetics 16. Current use of Class III antiarrhythmics Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Active duty and retired military service members ages 18-65 years 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale 3. Able to speak and read English (due to standardization of outcome measures) 4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed. Exclusion Criteria: 1. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider. 2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment) 3. Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment. 4. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment 5. Pregnancy or breastfeeding 6. Current anticoagulant use 7. History of bleeding disorder 8. Infection or mass at injection site 9. Myocardial infarction within 6 months of procedure 10. Pathologic bradycardia or irregularities of heart rate or rhythm 11. Symptomatic hypotension 12. Phrenic or laryngeal nerve palsy 13. History of glaucoma 14. Uncontrolled seizure disorder 15. History of allergy to local anesthetics 16. Current use of Class III antiarrhythmics

Treatments Being Tested

DRUG

Ropivacaine injection

6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion

DRUG

Normal saline

6.5cc of Normal Saline one time into the stellate ganglion.

Locations (2)

Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States