Stellate Ganglion Block + Cognitive Processing Therapy for PTSD

Overseen By Craig J Bryan, PsyD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University

Must be taking: Psychotropic medications

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if injecting a local anesthetic into the neck can help military personnel and veterans with PTSD when combined with standard therapy. The treatment targets the nerves that control stress responses to reduce anxiety symptoms. Participants will receive therapy and be randomly assigned to get the injection at different times. This method has been investigated in previous trials for its potential to reduce PTSD symptoms, showing some promise in symptom reduction.

Research Team

Craig J Bryan, PsyD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for U.S. military personnel and veterans over 18 who can speak English and have been diagnosed with PTSD within the last month. They must be on stable psychotropic meds for 3 months. It's not for those with severe brain injuries, substance abuse issues, high suicide risk, schizophrenia, psychotic or bipolar disorders, or previous SGB or CPT treatment.

Inclusion Criteria

I was diagnosed with PTSD in the last month.

Prior or current service in the U.S. military

Ability to speak and understand the English language

Exclusion Criteria

I am able to understand and give consent for my treatment.

I have previously received SGB or CPT treatment.

History of schizophrenia, another psychotic disorder, or bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Cognitive Processing Therapy (CPT)

Participants receive 12 sessions of cognitive processing therapy for PTSD

2 weeks

12 sessions (in-person)

Stellate Ganglion Block (SGB) Treatment

Participants receive stellate ganglion block treatment either during CPT or three months after completing CPT

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Cognitive Processing Therapy (CPT)
• Stellate Ganglion Block

Trial Overview The study tests if a Stellate Ganglion Block (SGB) can improve PTSD outcomes when combined with Cognitive Processing Therapy (CPT). Participants will receive CPT sessions over two weeks and SGB during or after therapy while their recovery progress is monitored.

Participant Groups

Group I: Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT) Experimental Treatment 2 Interventions

Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT.

Group II: SGB three months after completing CPT Experimental Treatment 2 Interventions

Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.

Cognitive Processing Therapy (CPT) is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Navy SEAL Foundation

Collaborator

Trials

1

Recruited

90+

The Stellate Institute

Collaborator

Trials

1

Recruited

90+