Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06570213
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Processing Therapy — BEHAVIORAL
    Cognitive Processing Therapy is a first-line, gold-standard psychotherapy intervention for the treatment of PTSD.
  • Stellate Ganglion Block — DRUG
    Stellate Ganglion Blocks are an injection of local anesthetic into the stellate ganglion, a collection of nerves in the side of the neck.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Sarah Pridgen, MA
[email protected]
312-942-1442
Philip Held, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Rush University Medical Center· Chicago, IL

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