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Completed

NCT Number: NCT04302181

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

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine injection

Drug

6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion

Other names: Naropin

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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