Actively Recruiting
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-09-04
140
Participants Needed
2
Research Sites
21 weeks
Total Duration
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
This clinical trial focuses on military service members or retirees aged 18 to 65 with post-traumatic stress disorder (PTSD). It aims to compare the effects of combining Massed Prolonged Exposure (PE), a type of behavioral therapy for PTSD, with a stellate ganglion block (SGB), which is an injection of a local anesthetic in the neck, against Massed PE combined with a sham injection. The study also seeks to understand how differences in psychophysiological responses during the exposure therapy relate to treatment outcomes. Participants will receive ten 90-minute Massed PE sessions conducted by qualified therapists over two weeks, Monday through Friday, involving about four to six hours of treatment daily including therapy and out-of-session assignments. Between the first and second PE sessions, participants will be randomly assigned to receive either a one-time SGB injection using 6.5cc of Ropivacaine or a sham injection of normal saline. After the initial treatment, participants may have three booster sessions offered at 1, 3, and 7 weeks post-treatment. Qualified medical personnel will administer the injections under standard procedures with monitoring during and after the procedure. Throughout the study, participants will undergo assessments before, during, and after treatment, including follow-ups at 1, 3, and 6 months after completing PE. The main outcomes measured include changes in PTSD symptoms using the Clinician-Administered PTSD Scale and the PTSD Checklist. Additional evaluations include questionnaires on depression, anxiety, and trauma-related thoughts, as well as psychophysiological measures such as skin response, heart rate, and movement during the two-week treatment period. Participants in the sham injection group will be offered the active SGB after the one-month assessment. The total study duration includes treatment and follow-up assessments lasting several months.
CONDITIONS
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 2 weeks
Participants receive individual 90-minute therapy sessions combined with out-of-session assignments, totaling approximately four to six hours of treatment per day, Monday through Friday, for two weeks. The stellate ganglion block injection or sham injection is administered between the first and second therapy sessions with medical supervision and a one-hour recovery period.
Daily visits Monday through Friday for 2 weeks, including injection and therapy sessions
Duration - Up to 6 months
Participants are offered three booster therapy sessions at 1, 3, and 7 weeks after treatment completion. Assessments are conducted at 1, 3, and 6 months following treatment to monitor progress.
1 visit at 1 week, 1 visit at 3 weeks, 1 visit at 7 weeks, and follow-up visits at 1, 3, and 6 months
Total: 2 locations
1
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544
Actively Recruiting
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
A
Amanda Flores
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Edna B Foa, Carmen P McLean, Yinyin Zang...
https://pubmed.ncbi.nlm.nih.gov/29362795Steven R Hanling, Anita Hickey, Ivan Lesnik...
https://pubmed.ncbi.nlm.nih.gov/27187898Eugene G Lipov, Jay R Joshi, Sergei Lipov...
https://pubmed.ncbi.nlm.nih.gov/19034755James H Lynch, Sean W Mulvaney, Eugene H Kim...
https://pubmed.ncbi.nlm.nih.gov/27612365Sean W Mulvaney, James H Lynch, Matthew J Hickey...
https://pubmed.ncbi.nlm.nih.gov/25269132Richard J Odosso, Lorene Petta
https://pubmed.ncbi.nlm.nih.gov/33242072Alan L Peterson, Tabatha H Blount, Edna B Foa...
https://pubmed.ncbi.nlm.nih.gov/36602803