Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD

Early Phase 1CompletedNCT04302181

The University of Texas Health Science Center at San Antonio12 enrolled

Overview

This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.

Massed PE will be conducted by doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. The stellate ganglion block injection will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration. During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ropivacaine injectionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Active duty or retired military service member (age 18- 65 years) 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5) 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 Brooke Army Medical Center for the stellate ganglion block. Exclusion Criteria: 1. Classification as high risk for suicide 2. Current serious mental health diagnosis (e.g., bipolar or psychosis) 3. Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days 4. Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding 5. Current anticoagulant use 6. History of bleeding disorder 7. Infection or mass at injection site 8. Myocardial infarction within 6 months of procedure 9. Pathologic bradycardia or irregularities of heart rate or rhythm; 10. Symptomatic hypotension 11. Phrenic or laryngeal nerve palsy 12. History of glaucoma 13. Uncontrolled seizure disorder 14. History of allergy to local anesthetics

Locations (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Change in CAPS-5 (Clinician-Administered PTSD Scale)

A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning.