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Stellate Ganglion Block + Cognitive Processing Therapy for PTSD

Phase 2

Recruiting

Led By Craig J Bryan, PsyD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PTSD within the last month

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52

Awards & highlights

Study Summary

This trial is looking at whether stellate ganglion block, a treatment for pain, can also help improve symptoms for people with PTSD who are receiving cognitive processing therapy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, generally SGB may cause temporary soreness at the injection site, drooping eyelids or red eyes temporarily due to nerve blockage near the neck area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with PTSD in the last month.

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I am 18 years old or older.

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My mental health medication dose has been the same for at least 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PTSD symptom severity

Secondary outcome measures

Change in anxiety symptom severity

Mental Depression

Change in good end-state functioning

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)Experimental Treatment2 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 CPTExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Processing Therapy (CPT)

2019

Completed Phase 3

~1400

Stellate Ganglion Block

2020

Completed Phase 2

~200

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Navy SEAL FoundationUNKNOWN

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,540 Total Patients Enrolled

The Stellate InstituteUNKNOWN

Media Library

Cognitive Processing Therapy (CPT) Clinical Trial Eligibility Overview. Trial Name: NCT05107752 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: SGB three months after completing CPT, Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)

Post-Traumatic Stress Disorder Clinical Trial 2023: Cognitive Processing Therapy (CPT) Highlights & Side Effects. Trial Name: NCT05107752 — Phase 2

Cognitive Processing Therapy (CPT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107752 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Cognitive Processing Therapy (CPT) for use?

"After careful consideration, our team at Power rated Cognitive Processing Therapy (CPT) a 2 on the safety scale as this is only a Phase 2 trial. Meaning there are some data supporting its security but none in regards to effectiveness and efficacy."

Answered by AI

Is this clinical experiment currently open for enrollment?

"Confirmed. Clinicaltrials.gov reveals that this clinical trial, which was originally published on January 3rd 2022, is actively recruiting participants. 80 individuals need to be recruited from 1 site specifically."

Answered by AI

How many individuals have registered for enrollment in this research?

"Affirmative. According to the information hosted on clinicaltrials.gov, this clinical experiment is attaining participants as of right now. It was initially posted on March 1st 2022 and most recently updated June 1st 2021; it seeks 80 individuals across a single medical site."

Answered by AI