Stellate Ganglion Block + Cognitive Processing Therapy for PTSD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining two treatments can better assist people with posttraumatic stress disorder (PTSD). It examines whether Stellate Ganglion Block (SGB), an injection in the neck that may help manage stress responses, combined with Cognitive Processing Therapy (CPT), a talking therapy, can more effectively reduce PTSD symptoms. Participants will receive different combinations of these treatments in groups. This trial may suit those who have experienced a traumatic event, have a PTSD diagnosis, and have not tried SGB before. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to explore this innovative approach.
Do I need to stop taking my current medications for the trial?
The trial requires that you have been on a stable dose of psychotropic medication for at least one month before starting and that you do not plan to change your medications within 3 months of starting the study. If you are on blood-thinning medications, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Stellate Ganglion Block (SGB) is generally safe. A review of 12 studies found that SGB can help reduce pain and is well-tolerated. One study reported a very low complication rate of 0.17%, meaning fewer than 2 out of 1,000 people experienced issues, suggesting that side effects are rare. Another study found that two SGB treatments, administered two weeks apart, improved PTSD symptoms without major safety concerns. Overall, SGB appears to be a safe option for managing PTSD symptoms.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for PTSD because they combine Cognitive Processing Therapy (CPT) with Stellate Ganglion Block (SGB) injections, which could offer faster relief than traditional methods. Unlike standard PTSD treatments, such as prolonged exposure therapy or medications like SSRIs, SGB targets the stellate ganglion to potentially modulate the sympathetic nervous system, offering a novel mechanism of action. This combination aims to enhance the effects of CPT by possibly reducing anxiety and hyperarousal more effectively. Additionally, the use of SGB with daily symptom monitoring could provide valuable insights into symptom fluctuations, helping tailor individual treatment plans.
What evidence suggests that this trial's treatments could be effective for PTSD?
Studies have shown that Stellate Ganglion Block (SGB) can effectively reduce PTSD symptoms. One study found that SGB led to significant improvements, with rapid improvement rates between 70% and 75%. Another study reported that two SGB treatments, given two weeks apart, effectively reduced symptoms over eight weeks. In this trial, one group will receive active SGB injections alongside Cognitive Processing Therapy, while another group will receive SGB with daily symptom monitoring. Research also indicates that symptom reduction for those receiving SGB was twice as large compared to those receiving a placebo. These findings suggest SGB may be a promising option for managing PTSD symptoms.12356
Are You a Good Fit for This Trial?
This trial is for English-speaking adults diagnosed with PTSD from a traumatic event, who have not had a Stellate Ganglion Block before. Participants need to own a smartphone, be able to attend two neck injections at the clinic, and take part in therapy or monitoring sessions over one week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo or active Stellate Ganglion Block injections and complete Cognitive Processing Therapy or daily symptom monitoring
Follow-up
Participants are monitored for PTSD symptom severity and functional improvements
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Processing Therapy
- Stellate Ganglion Block
Trial Overview
The study compares three groups: one gets both Cognitive Processing Therapy (CPT) and Stellate Ganglion Block (SGB), another gets CPT plus placebo injection, and the third receives SGB plus daily symptom monitoring. The goal is to see which approach best reduces PTSD symptoms up to six months later.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Citations
Stellate ganglion blockade for the treatment of post ...
A comprehensive review of 12 randomized controlled trials indicated that SGB treatment may lead to a decrease in pain intensity among patients suffering from ...
Stellate Ganglion Block for the Treatment of Post-Traumatic ...
In the identified primary study, SGB injections resulted in significantly greater improvements in PCL-5 and PCL-C-IV scores at 8 weeks compared to the sham ...
Differential posttraumatic stress disorder symptom cluster ...
... Effectiveness of stellate ganglion block for treatment of posttraumatic stress disorder (PTSD). (Department of Veterans Affairs, 2017) ...
4.
hsrd.research.va.gov
hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no124Effectiveness of Stellate Ganglion Block for Treatment of PTSD
SGB for PTSD had high rates of rapid clinical improvement in PTSD symptoms (70% to 75%). the range of mean percent PTSD improvement after one round of SGB was ...
Effect of Stellate Ganglion Block Treatment on ...
2 stellate ganglion block treatments 2 weeks apart were effective in reducing Clinician-Administered PTSD Scale for DSM-5 total symptom severity scores over 8 ...
NCT05169190 | Stellate Ganglion Block for PTSD
SGBs effects. durability of symptom reduction after SGB over 12 weeks, and c) safety (i.e., SGB will be as safe as Sham and WLC).
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