Recruiting

Early Phase 1

CPT & SGBEvaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD

Sponsor:

Rush University Medical Center

Code:

NCT06570213

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy

Stellate Ganglion Block

Study Details

Brief summary:

The purpose of this study is to understand if we can improve the treatment for posttraumatic stress disorder (PTSD). We are looking into whether the combination of Stellate Ganglion Block (SGB) treatment and Cognitive Processing Therapy (CPT) can reduce symptoms of PTSD. CPT is a trauma-focused talk therapy that can help identify and challenge unhelpful trauma-related beliefs about oneself, others, and the world. It is known to be a highly effective talk therapy for PTSD. SGB treatment is a procedure involving an injection of local anesthetic into a bundle of nerves located in the neck that is part of the sympathetic nervous system which controls our body's response to stressful situations and blocks pain.

The proposed project will systematically test whether combining CPT with SGB produces greater PTSD symptom reductions and functional improvements in the short- and longer-term up to 6-months follow-up compared to CPT (+Placebo) or SGB (+Daily Monitoring) alone.

Conditions

PTSD

Study ID

NCT06570213

Start date

Apr 1, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Stellate Ganglion Block + Cognitive Processing Therapy

Participants in this arm will receive two active Stellate Ganglion Block Injections, two weeks apart. After receiving the first injection, participants will complete 10 sessions of Cognitive Processing Therapy over the course of one week.

sham comparator: Placebo Injection + Cognitive Processing Therapy

Participants in this arm will receive two placebo (saline) Injections, two weeks apart. After receiving the first injection, participants will complete 10 sessions of Cognitive Processing Therapy over the course of one week.

placebo comparator: Active Stellate Ganglion Block + Daily Symptom Monitoring

Participants in this arm will receive two active Stellate Ganglion Block Injections, two weeks apart. After receiving the first injection, participants will complete 5 sessions of daily symptom monitoring with a member of study staff over the course of one week.

Interventions

Cognitive Processing Therapy

Cognitive Processing Therapy is a first-line, gold-standard psychotherapy intervention for the treatment of PTSD.

Stellate Ganglion Block

Stellate Ganglion Blocks are an injection of local anesthetic into the stellate ganglion, a collection of nerves in the side of the neck.

Primary outcome measure

Clinician Administered PTSD Scale for DSM-5 [ Time Frame: Baseline to 6 month follow up ]
PTSD Checklist for DSM-5 [ Time Frame: Baseline to 6 month follow up ]

Central Contacts and Locations

Central contacts

Philip Held, PhD

312-942-1423 philip_held@rush.edu

Sarah Pridgen, MA

312-563-0577 sarah_pridgen@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Sarah Pridgen, MA

312-942-1442 sarah_pridgen@rush.edu

Principal Investigator:

Philip Held, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-06-02.