PTSDEarly Phase 1NCT06570213
Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD
A Early Phase 1 study testing Cognitive Processing Therapy and Stellate Ganglion Block in people with PTSD, run by Rush University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Cognitive Processing Therapy and Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
- Have not previously received a Stellate Ganglion Block
- Have a smartphone that they can use for the entire duration of the study
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- Are willing and able to receive 2 injections (SGB or placebo) 2 weeks apart at the Rush Pain Clinic
- Are willing and able to participate in daily Cognitive Processing Therapy or Daily Monitoring over the course of one week
- Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
Who cannot join
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal (i.e., plan and intent)
- They have unmanaged psychosis or mania
- They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment or are planning to change their medications within 3 months of starting their participation in the study
- They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
- They have an intellectual disability or significant cognitive impairment that would prevent them from engaging fully in treatment
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- They are currently on any blood-thinning medications or have a coagulopathy -They have any of the following conditions: a recent myocardial infarction, glaucoma, a pre- existing contralateral nerve palsy, severe emphysema, or a cardiac conduction blockade.
- They are allergic to any of the medications injected (i.e., ropivacaine, lidocaine, propofol)
- They have an active infection
- They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
- They have a visual or auditory impairment that would prevent them from fully participating in study activities
- They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
- They have substance dependence that, in the judgment of the Principal Investigator, may require hospitalization if substances were discontinued.
- Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgment of the Principal Investigator, could affect the ability to deliver the intervention with fidelity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Sarah Pridgen, MA, 312-942-1442, sarah_pridgen@rush.edu
Philip Held, PhD
About this study
Official title: Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD: A Randomized Controlled Trial
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.
- Conditions
- PTSD
- Being tested
- Cognitive Processing Therapy, Stellate Ganglion Block
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Cognitive Processing Therapy is a first-line, gold-standard psychotherapy intervention for the treatment of PTSD.
Stellate Ganglion BlockDrug
Stellate Ganglion Blocks are an injection of local anesthetic into the stellate ganglion, a collection of nerves in the side of the neck.
| Study group | Role | What they receive |
|---|---|---|
| Active Stellate Ganglion Block + Cognitive Processing Therapy | Active comparator | 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. Receives: Behavioral: Cognitive Processing Therapy; Drug: Stellate Ganglion Block |
| Placebo Injection + Cognitive Processing Therapy | Sham comparator | 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. Receives: Behavioral: Cognitive Processing Therapy |
| Active Stellate Ganglion Block + Daily Symptom Monitoring | Placebo comparator | 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. Receives: Drug: Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5
A clinician rated assessment of PTSD
Measured: Baseline to 6 month follow up
PTSD Checklist for DSM-5
A self-report measure of PTSD symptom severity
Measured: Baseline to 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment of eligible participants will occur in two steps using a custom computer randomization algorithm. First, participants will be randomly assigned to receive either two active SGB injections or two placebo saline injections. In the second stage of random assignment, participants will be randomly assigned to receive 1-week of CPT or daily symptom monitoring. As there will only be three treatment conditions of this study (SGB+CPT, SGB+Daily Monitoring, and Placebo Injection+CPT), individuals that are randomly assigned to the placebo injection group in the first stage of random assignment will automatically be assigned to receive CPT.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Held, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570213
- Sponsor's protocol ID
- 23091404
- Status last verified
- May 2026
- First submitted
- 22 Aug 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06570213
- Acronym / sponsor ID
- 23091404
- Conditions
- PTSD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Random assignment of eligible participants will occur in two steps using a custom computer randomization algorithm. First, participants will be randomly assigned to receive either two active SGB injections or two placebo saline injections. In the second stage of random assignment, participants will be randomly assigned to receive 1-week of CPT or daily symptom monitoring. As there will only be three treatment conditions of this study (SGB+CPT, SGB+Daily Monitoring, and Placebo Injection+CPT), individuals that are randomly assigned to the placebo injection group in the first stage of random assignment will automatically be assigned to receive CPT.
| Arm | Type | Receives |
|---|---|---|
| Active Stellate Ganglion Block + Cognitive Processing Therapy | Active comparator | Behavioral: Cognitive Processing Therapy, Drug: Stellate Ganglion BlockParticipants 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. |
| Placebo Injection + Cognitive Processing Therapy | Sham comparator | Behavioral: Cognitive Processing TherapyParticipants 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. |
| Active Stellate Ganglion Block + Daily Symptom Monitoring | Placebo comparator | Drug: Stellate Ganglion BlockParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
- Have not previously received a Stellate Ganglion Block
Key exclusion criteria (14 listed)
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal (i.e., plan and intent)
- They have unmanaged psychosis or mania
- They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment or are planning to change their medications within 3 months of starting their participation in the study
- They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing TherapyCognitive Processing Therapy is a first-line, gold-standard psychotherapy intervention for the treatment of PTSD. | Behavioural | Active Stellate Ganglion Block + Cognitive Processing Therapy, Placebo Injection + Cognitive Processing Therapy |
| Stellate Ganglion BlockStellate Ganglion Blocks are an injection of local anesthetic into the stellate ganglion, a collection of nerves in the side of the neck. | Drug | Active Stellate Ganglion Block + Cognitive Processing Therapy, Active Stellate Ganglion Block + Daily Symptom Monitoring |
Primary outcome
Clinician Administered PTSD Scale for DSM-5
Time frame: Baseline to 6 month follow up
A clinician rated assessment of PTSD
PTSD Checklist for DSM-5
Time frame: Baseline to 6 month follow up
A self-report measure of PTSD symptom severity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Processing Therapy and Stellate Ganglion Block in people with PTSD, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Held, PhD (312-942-1423, philip_held@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for DSM-5 (time frame: Baseline to 6 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.