Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05889741
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 140
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic	Drug: Ropivacaine injection; Drug: Normal saline	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2026
• Anticipated Study Completion Date: Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stellate Ganglion Block One time administration of a stellate ganglion block	Drug: Ropivacaine injection; 6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion; Other Names: Naropin
Placebo Comparator: Sham SGB One time administration	Drug: Normal saline; 6.5cc of Normal Saline one time into the stellate ganglion.

Outcome Measures

Primary Outcome Measures

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

1. Patient Health Questionnaire-9 items (PHQ-9) [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) [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) [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 [Two weeks]

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

5. Psychophysiological arousal - Skin Temperature [Two weeks]

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

6. Psychophysiological arousal - Heart Rate [Two weeks]

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

7. Psychophysiological arousal - Interbeat Interval [Two weeks]

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

8. Psychophysiological arousal - Three-Dimensional Accelerometer Movement [Two weeks]

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

9. Psychophysiological arousal - Electrodermal Activity [Two weeks]

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

10. Psychophysiological arousal - Photoplethysmography [Two weeks]

    Change in Psychophysiological data collected from a smart watch measuring photoplethysmography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Active duty and retired military service members ages 18-65 years

2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale

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 a military treatment facility (MTF) where the stellate ganglion block will be placed.

Exclusion Criteria:

1. 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.

2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)

3. Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.

4. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment

5. Pregnancy or breastfeeding

6. Current anticoagulant use

7. History of bleeding disorder

8. Infection or mass at injection site

9. Myocardial infarction within 6 months of procedure

10. Pathologic bradycardia or irregularities of heart rate or rhythm

11. Symptomatic hypotension

12. Phrenic or laryngeal nerve palsy

13. History of glaucoma

14. Uncontrolled seizure disorder

15. History of allergy to local anesthetics

16. Current use of Class III antiarrhythmics

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio
• United States Department of Defense

Investigators

• Principal Investigator: Alan Peterson, PhD, The University of Texas Health Science Center at San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Erratum In: JAMA. 2018 Aug 21;320(7):724.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT05889741
• Other Study ID Numbers: HSC20230087H
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 8, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by The University of Texas Health Science Center at San Antonio: SGB; Military
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic; Ropivacaine

Study Results

No Results Posted as of Jun 8, 2023