Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD

Study Overview
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Brief Summary
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This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.

Detailed Description
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Massed PE will be conducted by 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. The stellate ganglion block injection 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. During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.

Official Title
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Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members: A Pilot Study

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Drug: Ropivacaine injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active duty or retired military service member (age 18- 65 years) PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5) Able to speak and read English (due to standardization of outcome measures) Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block. Exclusion Criteria: Classification as high risk for suicide Current serious mental health diagnosis (e.g., bipolar or psychosis) Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days Pregnancy (i.e. positive pregnancy test at screening) 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

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
Intervention Model: Single Group Assignment
Interventional Model Description: A small open-label treatment study
Masking: None (Open Label)


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 HCl 0.5%, one time into the stellate ganglion<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CAPS-5 (Clinician-Administered PTSD Scale) | A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. | Baseline, 1 month and 3 months | 
| Change in PCL-5 (Posttraumatic Stress Disorder Checklist) | A 20-item self-report measure that assesses the presence and severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). | Baseline, 1 month and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PHQ-9 (Patient Health Questionnaire-9) | A 9-item self-report measure that assesses the presence and severity of depressive symptoms. | Baseline, 1 month and 3 months | 
| Change in Brief Inventory of Psychosocial Functioning | A 7-item self-report measure assessing respondents' level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. | Baseline, 1 month and 3 months | 
| Change in GAD-7 (General Anxiety Disorder Screener) | A 9-item self-report measure that assesses the presence and severity of general anxiety symptoms. | Baseline, 1 month and 3 months | 
| Change in PTCI (Posttraumatic Cognitions Inventory) | A 36-item self-report measure that assesses self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. | Baseline, 1 month and 3 months |