Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05889741

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Carl R. Darnall Army Medical Center, Fort Hood, Texas, United States

Loading trial locations.

About this study

Massed PE will be conducted by master-level or 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. Each participant will also be offered three booster sessions at 1-, 3-, and 7-weeks posttreatment.

The stellate ganglion block injection or the sham SGB 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.

Assessments will be administered at pretreatment, during treatment, at posttreatment, and at 1-, 3-, and 6-months following the completion of PE. The primary outcome assessment will be 1-month following the completion of PE. Following this assessment, participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Ropivacaine injection

Drug

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

Other names: Naropin

normal saline

Drug

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

Primary outcomes

  1. Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)

    Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments

    A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis.

  2. Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)

    Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments

    A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity.

Secondary outcomes

  1. Patient Health Questionnaire-9 items (PHQ-9)

    Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments

    A 9-item self-report measure that assesses the presence and change in severity of depressive symptoms. Total scores range from 0 to 27 with higher scores reflective of greater severity.

  2. General Anxiety Disorder Screener - 7 Items (GAD-7)

    Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments

    A 9-item self-report measure that assesses the presence and change in severity of general anxiety symptoms. Total scores range from 0 to 21 with higher scores reflective of greater severity.

  3. Posttraumatic Cognitions Inventory (PTCI)

    Time frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments

    A 36-item self-report measure that assesses change in self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. Total scores range from 33 to 231 with higher scores reflective of more problematic cognitions.

  4. Psychophysiological arousal - Galvanic Skin Response

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring galvanic skin response

  5. Psychophysiological arousal - Skin Temperature

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring skin temperature

  6. Psychophysiological arousal - Heart Rate

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring heart rate

  7. Psychophysiological arousal - Interbeat Interval

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring interbeat interval

  8. Psychophysiological arousal - Three-Dimensional Accelerometer Movement

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement

  9. Psychophysiological arousal - Electrodermal Activity

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring electrodermal activity

  10. Psychophysiological arousal - Photoplethysmography

    Time frame: Two weeks

    Change in Psychophysiological data collected from a smart watch measuring photoplethysmography

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Flores

CONTACT

[email protected]

210-562-6726

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.