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

Sponsor
Rush University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534126
Collaborator
(none)
150
1
2
48.8
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stellate Ganglion Block Treatment
  • Procedure: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial
Anticipated Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Stellate Ganglion Block

Procedure: Stellate Ganglion Block Treatment
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.

Placebo Comparator: Placebo

Procedure: Placebo
Sham

Outcome Measures

Primary Outcome Measures

  1. Clinician Administered PTSD Scale for DSM-5 [Through study completion, on average of 3 months]

    Clinician Administered Assessment of PTSD

  2. PTSD Checklist for DSM-5 Criteria [Through study completion, on average of 3 months]

    Self-report measure for PTSD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philip Held, Research Director, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT05534126
Other Study ID Numbers:
  • 22011306
First Posted:
Sep 9, 2022
Last Update Posted:
Sep 9, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2022