Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Bl… (NCT05534126) | Clinical Trial Compass
CompletedNot Applicable
Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial
United States60 participantsStarted 2022-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
Exclusion criteria
✕. The traumatic event occurred in the past month
✕. They are currently suicidal or homicidal (i.e., plan and intent)
What they're measuring
1
Clinician Administered PTSD Scale for DSM-5
Timeframe: Through study completion, on average of 3 months
2
PTSD Checklist for DSM-5 Criteria
Timeframe: Through study completion, on average of 3 months
✕. 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.