Combining Cognitive Processing Therapy with Stellate Ganglion Block for PTSD treatment
Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: a Pilot Trial
This study is testing if adding a pain-blocking treatment to therapy can help people with PTSD feel better than therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05534126 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining Cognitive Processing Therapy (CPT) with Stellate Ganglion Block (SGB) treatment for individuals diagnosed with Posttraumatic Stress Disorder (PTSD). CPT is a well-established therapy for PTSD, but many patients do not fully recover. The study aims to determine if the addition of SGB, which blocks pain signal transmissions, can enhance the outcomes of CPT. Participants will undergo a one-week program of daily CPT sessions alongside SGB treatment to evaluate the combined effects on PTSD symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have a verified PTSD diagnosis and reside in Illinois.
Not a fit: Patients who have experienced a traumatic event within the past month or have unmanaged mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with PTSD.
How similar studies have performed: While previous studies have explored SGB as a standalone treatment for PTSD, this combined approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.