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Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ropivacaine injection
Normal saline
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring SGB, Military

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Stellate Ganglion Block

    Sham SGB

    Arm Description

    One time administration of a stellate ganglion block

    One time administration

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Patient Health Questionnaire-9 items (PHQ-9)
    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.
    General Anxiety Disorder Screener - 7 Items (GAD-7)
    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.
    Posttraumatic Cognitions Inventory (PTCI)
    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.
    Psychophysiological arousal - Galvanic Skin Response
    Change in Psychophysiological data collected from a smart watch measuring galvanic skin response
    Psychophysiological arousal - Skin Temperature
    Change in Psychophysiological data collected from a smart watch measuring skin temperature
    Psychophysiological arousal - Heart Rate
    Change in Psychophysiological data collected from a smart watch measuring heart rate
    Psychophysiological arousal - Interbeat Interval
    Change in Psychophysiological data collected from a smart watch measuring interbeat interval
    Psychophysiological arousal - Three-Dimensional Accelerometer Movement
    Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement
    Psychophysiological arousal - Electrodermal Activity
    Change in Psychophysiological data collected from a smart watch measuring electrodermal activity
    Psychophysiological arousal - Photoplethysmography
    Change in Psychophysiological data collected from a smart watch measuring photoplethysmography

    Full Information

    First Posted
    April 17, 2023
    Last Updated
    September 25, 2023
    Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    United States Department of Defense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05889741
    Brief Title
    Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
    Official Title
    Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2026 (Anticipated)
    Study Completion Date
    August 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    United States Department of Defense

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Disorders, Post-Traumatic
    Keywords
    SGB, Military

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stellate Ganglion Block
    Arm Type
    Experimental
    Arm Description
    One time administration of a stellate ganglion block
    Arm Title
    Sham SGB
    Arm Type
    Placebo Comparator
    Arm Description
    One time administration
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine injection
    Other Intervention Name(s)
    Naropin
    Intervention Description
    6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Intervention Description
    6.5cc of Normal Saline one time into the stellate ganglion.
    Primary Outcome Measure Information:
    Title
    Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)
    Description
    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.
    Time Frame
    Baseline and at 1-month, 3-month, and 6-month follow-up assessments
    Title
    Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)
    Description
    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.
    Time Frame
    Baseline and at 1-month, 3-month, and 6-month follow-up assessments
    Secondary Outcome Measure Information:
    Title
    Patient Health Questionnaire-9 items (PHQ-9)
    Description
    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.
    Time Frame
    Baseline and at 1-month, 3-month, and 6-month follow-up assessments
    Title
    General Anxiety Disorder Screener - 7 Items (GAD-7)
    Description
    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.
    Time Frame
    Baseline and at 1-month, 3-month, and 6-month follow-up assessments
    Title
    Posttraumatic Cognitions Inventory (PTCI)
    Description
    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.
    Time Frame
    Baseline and at 1-month, 3-month, and 6-month follow-up assessments
    Title
    Psychophysiological arousal - Galvanic Skin Response
    Description
    Change in Psychophysiological data collected from a smart watch measuring galvanic skin response
    Time Frame
    Two weeks
    Title
    Psychophysiological arousal - Skin Temperature
    Description
    Change in Psychophysiological data collected from a smart watch measuring skin temperature
    Time Frame
    Two weeks
    Title
    Psychophysiological arousal - Heart Rate
    Description
    Change in Psychophysiological data collected from a smart watch measuring heart rate
    Time Frame
    Two weeks
    Title
    Psychophysiological arousal - Interbeat Interval
    Description
    Change in Psychophysiological data collected from a smart watch measuring interbeat interval
    Time Frame
    Two weeks
    Title
    Psychophysiological arousal - Three-Dimensional Accelerometer Movement
    Description
    Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement
    Time Frame
    Two weeks
    Title
    Psychophysiological arousal - Electrodermal Activity
    Description
    Change in Psychophysiological data collected from a smart watch measuring electrodermal activity
    Time Frame
    Two weeks
    Title
    Psychophysiological arousal - Photoplethysmography
    Description
    Change in Psychophysiological data collected from a smart watch measuring photoplethysmography
    Time Frame
    Two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amanda Flores
    Phone
    210-562-6726
    Email
    floresa13@uthscsa.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tabatha Blount, PhD
    Phone
    2105626718
    Email
    blountt@uthscsa.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alan Peterson, PhD
    Organizational Affiliation
    The University of Texas Health Science Center at San Antonio
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29362795
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27187898
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19034755
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27612365
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25269132
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33242072
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36602803
    Citation
    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.
    Results Reference
    background

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