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

Chronic Pain Clinical Trial

— SGB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534126
• Other study ID #: 22011306
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
Sham

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale for DSM-5	Clinician Administered Assessment of PTSD	Through study completion, on average of 3 months
Primary	PTSD Checklist for DSM-5 Criteria	Self-report measure for PTSD	Through study completion, on average of 3 months