NCT05889741

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
16mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2024Aug 2027

First Submitted

Initial submission to the registry

April 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3.1 years

First QC Date

April 17, 2023

Last Update Submit

August 27, 2025

Conditions

Stress Disorders, Post-Traumatic

Keywords

SGBMilitary

Outcome Measures

Primary Outcomes (2)

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

    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.

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

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

    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.

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

Secondary Outcomes (10)

  • Patient Health Questionnaire-9 items (PHQ-9)

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

  • General Anxiety Disorder Screener - 7 Items (GAD-7)

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

  • Posttraumatic Cognitions Inventory (PTCI)

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

  • Psychophysiological arousal - Galvanic Skin Response

    Two weeks

  • Psychophysiological arousal - Skin Temperature

    Two weeks

  • +5 more secondary outcomes

Study Arms (2)

Stellate Ganglion Block

EXPERIMENTAL

One time administration of a stellate ganglion block

Drug: Ropivacaine injection

Sham SGB

PLACEBO COMPARATOR

One time administration

Drug: Normal saline

Interventions

Ropivacaine injectionDRUG

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

Also known as: Naropin
Stellate Ganglion Block
Normal salineDRUG

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

Sham SGB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (7)

  • Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.

    PMID: 29362795BACKGROUND

  • Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402.

    PMID: 27187898BACKGROUND

  • Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.

    PMID: 19034755BACKGROUND

  • Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518.

    PMID: 27612365BACKGROUND

  • Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.

    PMID: 25269132BACKGROUND

  • Odosso RJ, Petta L. The Efficacy of the Stellate Ganglion Block as a Treatment Modality for Posttraumatic Stress Disorder Among Active Duty Combat Veterans: A Pilot Program Evaluation. Mil Med. 2021 Jul 1;186(7-8):e796-e803. doi: 10.1093/milmed/usaa246.

    PMID: 33242072BACKGROUND

  • Peterson AL, Blount TH, Foa EB, Brown LA, McLean CP, Mintz J, Schobitz RP, DeBeer BR, Mignogna J, Fina BA, Evans WR, Synett S, Hall-Clark BN, Rentz TO, Schrader C, Yarvis JS, Dondanville KA, Hansen H, Jacoby VM, Lara-Ruiz J, Straud CL, Hale WJ, Shah D, Koch LM, Gerwell KM, Young-McCaughan S, Litz BT, Meyer EC, Blankenship AE, Williamson DE, Roache JD, Javors MA, Sharrieff AM, Niles BL, Keane TM; Consortium to Alleviate PTSD. Massed vs Intensive Outpatient Prolonged Exposure for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2249422. doi: 10.1001/jamanetworkopen.2022.49422.

    PMID: 36602803BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

RopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Alan Peterson, PhD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Flores

CONTACT

210-562-6726floresa13@uthscsa.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The clinical staff, research staff, and the participant will be blind to study condition until after the 1-month follow-up assessment. After which time, the blind will be broken, and participants in the control condition will be offered the SGB.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

June 5, 2023

Study Start

February 26, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)