BridgeMD
Tests treatment safety and results for PTSD
Official title Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD
ClinicalTrials.gov ID: NCT06570213
What this study is testing
What is Stellate Ganglion Block?
Stellate Ganglion Block is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3...
- They have an intellectual disability or significant cognitive impairment that would prevent them from engaging fully in treatment
See the full eligibility criteria
- 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
- 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
- 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...
- 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
- 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...
- 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.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.