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

September 8, 2022 updated by: The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Active duty or retired military service member (age 18- 65 years)
  2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
  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 Brooke Army Medical Center for the stellate ganglion block.

Exclusion Criteria:

  1. Classification as high risk for suicide
  2. Current serious mental health diagnosis (e.g., bipolar or psychosis)
  3. Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
  4. Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
  5. Current anticoagulant use
  6. History of bleeding disorder
  7. Infection or mass at injection site
  8. Myocardial infarction within 6 months of procedure
  9. Pathologic bradycardia or irregularities of heart rate or rhythm;
  10. Symptomatic hypotension
  11. Phrenic or laryngeal nerve palsy
  12. History of glaucoma
  13. Uncontrolled seizure disorder
  14. History of allergy to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stellate Ganglion Block
One time administration of a stellate ganglion block
Drug: Ropivacaine injection
6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CAPS-5 (Clinician-Administered PTSD Scale)
Time Frame: Baseline, 1 month and 3 months
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)
Time Frame: Baseline, 1 month and 3 months
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)
Time Frame: Baseline, 1 month and 3 months
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
Time Frame: Baseline, 1 month and 3 months
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)
Time Frame: Baseline, 1 month and 3 months
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)
Time Frame: Baseline, 1 month and 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Alan Peterson, PhD, ABPP, University of Texas Health San Antonio Texas at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20190878H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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