About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Cognitive Processing Therapy
BehavioralCognitive Processing Therapy is a first-line, gold-standard psychotherapy intervention for the treatment of PTSD.
Stellate Ganglion Block
DrugStellate Ganglion Blocks are an injection of local anesthetic into the stellate ganglion, a collection of nerves in the side of the neck.
Treatment groups
Trial outcomes
Primary outcomes
Clinician Administered PTSD Scale for DSM-5
A clinician rated assessment of PTSD
PTSD Checklist for DSM-5
A self-report measure of PTSD symptom severity
Sponsors and contacts
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