Combined CPT and Stellate Ganglion Block for PTSD in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study will compare CPT alone, SGB alone, and the combination of CPT plus SGB in adults with PTSD. Participants will receive two injections two weeks apart and engage in either daily CPT or daily monitoring for one week, with assessments over several timepoints up to 6 months. The goal is to see if combining a nerve-block procedure with trauma-focused therapy offers greater symptom relief and improved functioning. The trial is conducted at Rush University Medical Center in Chicago and includes adults fluent in English who have experienced a qualifying traumatic event and meet PTSD criteria. Safety monitoring and standardized assessments will be used to evaluate outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are 18 years or older
* Are fluent in English
* 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 a Stellate Ganglion Block
* Have a smartphone that they can use for the entire duration of the study
* Are willing and able to receive 2 injections (SGB or placebo) 2 weeks apart at the Rush Pain Clinic
* Are willing and able to participate in daily Cognitive Processing Therapy or Daily Monitoring 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 3 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 fully in treatment
* 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)
* 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
* They have substance dependence that, in the judgment of the Principal Investigator, may require hospitalization if substances were discontinued.
* Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgment of the Principal Investigator, could affect the ability to deliver the intervention with fidelity

Where it's running

• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Philip Held, PhD
• Email: philip_held@rush.edu
• Phone: 312-942-1423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.