Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Drug: Ropivacaine injection
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments | 
| 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. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments | 
| 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. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments | 
| Psychophysiological arousal - Galvanic Skin Response | Change in Psychophysiological data collected from a smart watch measuring galvanic skin response | Two weeks | 
| Psychophysiological arousal - Skin Temperature | Change in Psychophysiological data collected from a smart watch measuring skin temperature | Two weeks | 
| Psychophysiological arousal - Heart Rate | Change in Psychophysiological data collected from a smart watch measuring heart rate | Two weeks | 
| Psychophysiological arousal - Interbeat Interval | Change in Psychophysiological data collected from a smart watch measuring interbeat interval | Two weeks | 
| Psychophysiological arousal - Three-Dimensional Accelerometer Movement | Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement | Two weeks | 
| Psychophysiological arousal - Electrodermal Activity | Change in Psychophysiological data collected from a smart watch measuring electrodermal activity | Two weeks | 
| Psychophysiological arousal - Photoplethysmography | Change in Psychophysiological data collected from a smart watch measuring photoplethysmography | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGB, Military