Study of Stellate Ganglion Block and Prolonged Exposure Therapy for PTSD in Military Members Comparing Real and Sham Injections to Improve PTSD Treatment Outcomes

What this Trial Is About

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.

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD