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Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial (SGB)

Primary Purpose

Posttraumatic Stress Disorder, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stellate Ganglion Block Treatment
Placebo
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

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

Inclusion Criteria:

  1. Are 18 years or older
  2. Are fluent in English
  3. Reside in Illinois
  4. Have safe transportation means other than driving themselves to Rush University Medical Center for two separate procedures (e.g., Uber, family or friend to drive them to study visits, etc.)
  5. Have experienced a Criterion A traumatic event during their lifetime
  6. Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
  7. Have not previously received stellate ganglion blocks
  8. Are willing and able to participate in daily Cognitive Processing Therapy over the course of one week
  9. Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study

Exclusion Criteria:

  1. The traumatic event occurred in the past month
  2. They are currently suicidal or homicidal (i.e., plan and intent)
  3. They have unmanaged psychosis or mania
  4. They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment or are planning to change their medications within 3 months of starting their participation in the study
  5. They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 12 months or are currently receiving an evidence-based PTSD treatment
  6. They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT, as assessed via the Mini-Mental State Exam-Second Edition (MMSE-2)
  7. They are currently on any blood-thinning medications or have a coagulopathy
  8. They have any of the following conditions: a recent myocardial infarction, glaucoma, a pre-existing contralateral nerve palsy, severe emphysema or a cardiac conduction blockade.
  9. They are allergic to any of the medications injected (i.e., ropivacaine, lidocaine, propofol, medications)
  10. They have an active infection
  11. They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
  12. They have a visual or auditory impairment that would prevent them from fully participating in study activities
  13. They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
  14. Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity

Sites / Locations

  • Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Stellate Ganglion Block

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale for DSM-5
Clinician Administered Assessment of PTSD
PTSD Checklist for DSM-5 Criteria
Self-report measure for PTSD

Secondary Outcome Measures

Full Information

First Posted
September 6, 2022
Last Updated
November 18, 2022
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05534126
Brief Title
Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial
Acronym
SGB
Official Title
Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cognitive Processing Therapy (CPT) is an effective first-line, evidence-based treatment for posttraumatic stress disorder (PTSD). Despite its well-demonstrated effectiveness, research has shown that approximately two-thirds of individuals continue to meet the diagnostic criteria for PTSD even after successful treatment completion. Stellate Ganglion Block (SGB) treatment, involving a local anesthesia injection to the stellate ganglion (around the lower base of the neck), has been shown to block its pain signal transmissions. Prior case studies and reviews have provided evidence for reducing PTSD symptoms with SGB treatment. However, studies to date have only examined SGB as a standalone intervention. The utility of combining CPT with concurrent SGB treatment remains unknown, although it is plausible that the combination of the two treatments can improve the effectiveness of CPT alone. The present study aims to test this hypothesis by comparing either a combined 1-week massed CPT + SGB treatment and 1-week massed CPT + placebo treatment (saline injection) using a randomized controlled trial design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stellate Ganglion Block
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Stellate Ganglion Block Treatment
Intervention Description
Stellate ganglion block procedure is a treatment that involves injection of local anesthetic around the stellate ganglion (located at the base of the neck) to block its transmission of pain signals.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Sham
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale for DSM-5
Description
Clinician Administered Assessment of PTSD
Time Frame
Through study completion, on average of 3 months
Title
PTSD Checklist for DSM-5 Criteria
Description
Self-report measure for PTSD
Time Frame
Through study completion, on average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are 18 years or older Are fluent in English Reside in Illinois Have safe transportation means other than driving themselves to Rush University Medical Center for two separate procedures (e.g., Uber, family or friend to drive them to study visits, etc.) Have experienced a Criterion A traumatic event during their lifetime Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5 Have not previously received stellate ganglion blocks Are willing and able to participate in daily Cognitive Processing Therapy over the course of one week Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study Exclusion Criteria: The traumatic event occurred in the past month They are currently suicidal or homicidal (i.e., plan and intent) They have unmanaged psychosis or mania They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment or are planning to change their medications within 3 months of starting their participation in the study They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 12 months or are currently receiving an evidence-based PTSD treatment They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT, as assessed via the Mini-Mental State Exam-Second Edition (MMSE-2) They are currently on any blood-thinning medications or have a coagulopathy They have any of the following conditions: a recent myocardial infarction, glaucoma, a pre-existing contralateral nerve palsy, severe emphysema or a cardiac conduction blockade. They are allergic to any of the medications injected (i.e., ropivacaine, lidocaine, propofol, medications) They have an active infection They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year They have a visual or auditory impairment that would prevent them from fully participating in study activities They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Held, PhD
Phone
312-942-1423
Email
philip_held@rush.edu
First Name & Middle Initial & Last Name & Degree
Sarah Pridgen, MA
Phone
312-563-0577
Email
sarah_pridgen@rush.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial

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