Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
The University of Texas Health Science Center at San Antonio
140 participants
Feb 26, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Active duty and retired military service members ages 18-65 years
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
- Able to speak and read English (due to standardization of outcome measures)
- 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 Criteria16
- 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.
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
- Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
- Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
- Pregnancy or breastfeeding
- Current anticoagulant use
- History of bleeding disorder
- Infection or mass at injection site
- Myocardial infarction within 6 months of procedure
- Pathologic bradycardia or irregularities of heart rate or rhythm
- Symptomatic hypotension
- Phrenic or laryngeal nerve palsy
- History of glaucoma
- Uncontrolled seizure disorder
- History of allergy to local anesthetics
- Current use of Class III antiarrhythmics
Interventions
6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
6.5cc of Normal Saline one time into the stellate ganglion.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05889741