Clinical trial

Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD

Name
2021H0228
Description
Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD). The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive processing therapy (CPT), an empirically-supported psychological treatment for PTSD. To accomplish this objective, we will enroll adult military personnel and veterans with a current diagnosis of PTSD and/or subthreshold PTSD, provide CPT sessions over two weeks, administer SGB during or after CPT, and repeatedly assess key outcomes during follow-up.
Trial arms
Trial start
2022-01-03
Estimated PCD
2024-11-01
Trial end
2024-11-01
Status
Recruiting
Phase
Early phase I
Treatment
Cognitive Processing Therapy (CPT)
Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.
Arms:
SGB three months after completing CPT, Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)
Stellate Ganglion Block
SGB is a procedure that has demonstrated efficacy for the reduction of PTSD symptoms. SGB is performed using real-time ultrasonography with an in-plane technique, and consists of 7-10 mL of ropivacaine 0.5%, which is injected around and into the site of the ganglion at the level of the C4 and C6 anterior tubercle (Mulvaney, Curtis et al., 2020). Ropivacaine is a long-acting amide local anesthetic agent and a pure S-enantiomer with a high pKa and relatively low solubility. Patients are not sedated during the procedure. Successful sympathetic blockade is confirmed by the presence of Horner's syndrome, which is characterized by constriction of the pupil (miosis) and drooping of the upper eyelid (ptosis). If Horner's syndrome is not observed within 20 minutes of the first injection, the right-sided SGB is repeated one hour later using the same technique. If Horner's syndrome is not confirmed after the second injection, no additional injections are provided.
Arms:
SGB three months after completing CPT, Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)
Size
80
Primary endpoint
Change in PTSD symptom severity
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
Eligibility criteria
Inclusion Criteria: * 18 years of age or older * Prior or current service in the U.S. military * Diagnosis of PTSD within the last month * Ability to speak and understand the English language * Stable psychotropic medication dosing for at least 3 months * Ability to complete the informed consent process Exclusion Criteria: * Prior SGB treatment or CPT treatment * History of schizophrenia, another psychotic disorder, or bipolar disorder * Moderate or severe traumatic brain injury * Moderate or severe symptoms of a substance use disorder within the preceding 30 days * Severe suicide risk warranting suicide-focused treatment and/or inpatient hospitalization * Impaired mental status that precludes the ability to provide informed consent * Any ongoing stressor or condition deemed by the investigators to place the participant at risk for injury or a poor outcome
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'All participants receive cognitive processing therapy during weeks 1 and 2. Participants will be randomly allocated to receive SGB during or 3 months after CPT.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-03-28

1 organization