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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve PTSD (posttraumatic stress disorder) treatment by combining two therapies. It examines the effectiveness of a procedure called stellate ganglion block (SGB)—a nerve-blocking treatment—when added to cognitive processing therapy (CPT), a common psychological therapy for PTSD. The trial tests SGB during and after CPT to determine the most effective timing. It is open to military personnel or veterans diagnosed with PTSD in the past month who can speak and understand English. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Do I have to stop taking my current medications for the trial?

The trial requires that your current psychotropic medication dosage has been stable for at least 3 months, so you should not need to stop taking them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the stellate ganglion block (SGB) procedure is generally safe and well-tolerated for treating PTSD. Studies indicate that SGB does not negatively affect cognitive abilities and is accepted by patients as a treatment option. Additionally, some research has found that SGB can effectively reduce PTSD symptoms.

Cognitive processing therapy (CPT) is a well-researched treatment for PTSD, widely used and considered safe. CPT involves discussing trauma-related thoughts to help lessen PTSD symptoms. Safety studies have demonstrated that CPT is effective and poses minimal risk to participants.

Both treatments have strong safety records, making them promising options for those with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Stellate Ganglion Block (SGB) and Cognitive Processing Therapy (CPT) for PTSD because it offers unique approaches compared to traditional treatments like medication and standard talk therapy. SGB is a nerve block procedure that potentially provides rapid relief from PTSD symptoms by targeting the sympathetic nervous system, which is different from typical therapies that focus on cognitive and emotional processing over time. Additionally, the trial explores two distinct timing strategies: one arm investigates the impact of administering SGB during the first week of CPT, potentially enhancing therapy effectiveness from the start, while the other arm evaluates the benefits of SGB administered three months after completing CPT, aiming to sustain or boost long-term results. This innovative combination and timing could provide faster and more enduring relief for those suffering from PTSD.

What evidence suggests that this trial's treatments could be effective for PTSD?

Studies have shown that a stellate ganglion block (SGB), a type of nerve block, can help reduce PTSD symptoms. In some cases, symptoms improved by 12.1% to 21.2% after two SGB treatments. Cognitive Processing Therapy (CPT) is another effective treatment for PTSD and often surpasses other methods. Research indicates that CPT can lessen PTSD symptoms and improve related issues like depression. In this trial, one group of participants will receive SGB three months after completing CPT, while another group will receive SGB during the first week of CPT. Combining SGB with CPT might offer even greater benefits for people with PTSD. ^{2 3 4 6 7}

Who Is on the Research Team?

Craig J Bryan, PsyD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

I have had a moderate or severe brain injury.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD To date, CPT has been shown to improve common comorbid symptoms and clinical correlates of PTSD such as depression (12,33), suicidal ideation (34), health- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ... A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.

7. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/c/NCT04230668.html

Cognitive Processing Therapy (CPT) for Posttraumatic Stress ... Both treatment conditions will be administered via telehealth. Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms.