Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD
- Conditions
- PTSDTrauma and Stressor Related DisordersTrauma, PsychologicalPost Traumatic Stress Disorder
- Interventions
- Behavioral: Cognitive Processing Therapy (CPT)Drug: Stellate Ganglion Block
- Registration Number
- NCT05107752
- Lead Sponsor
- Ohio State University
- Brief Summary
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.
- Detailed Description
Posttraumatic stress disorder (PTSD) is the most frequently diagnosed mental health condition among veterans (Tanielian \& Jaycox, 2008), with estimated rates of the condition ranging from 5-20% (Hoge, Castro, et al., 2004; Hoge, Terhakopian, et al., 2007; Milliken, Auchterlonie, \& Hoge, 2007; Tanielian \& Jaycox, 2008). PTSD is not just a consequence of combat, however; many military personnel and veterans experience noncombat-related traumas such as sexual assault and domestic abuse, or have histories of early life trauma such as child abuse that can also contribute to PTSD. Regardless of the associated event, PTSD is associated with a host of functional problems and negative outcomes among military personnel including occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide (Hoge et al., 2004; Jakupcak et al., 2007; Panagioti, Gooding, \& Tarrier, 2009).
Cognitive behavioral treatments are the most highly efficacious treatments for PTSD. Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was the most effective treatment for PTSD (Watts et al., 2013), typically yielding a 50% or larger reduction in PTSD symptoms from pre- to posttreatment. Despite CPT's effectiveness, a significant percentage of military veterans continue to experience moderate to severe symptoms afterwards, and nearly half continue to meet full criteria for the diagnosis (Harik, Grubbs, \& Schnurr, 2016). Novel strategies for improving treatment outcomes are therefore needed.
Accumulating evidence supports the effectiveness of stellate ganglion block (SGB) for the treatment of PTSD. SGB is a procedure in which an injection of a long-acting local anesthetic, using ultrasound or fluoroscopic guidance, is made in the right side of the neck around the cervical sympathetic chain that controls the "fight or flight" response (the sympathetic nervous system). The cervical sympathetic chain is a two-way conduit that connects the parts of the brain that control the fight or flight response to the rest of the body. By blocking or "turning off" the cervical sympathetic chain, it is believed that the parts of the brain that control the fight or flight response are allowed to completely reset, resulting in long-term relief of the associated anxiety symptoms. Originally developed for the treatment of pain conditions, multiple case series have shown that right-sided SGB is associated with significant reductions in PTSD symptoms after SGB (Alino et al., 2013; Hickey et al., 2012; Lipov et al., 2008; Mulvaney et al., 2010, 2014), especially negative mood and hyperarousal symptoms (Lynch et al., 2016). Results of a recent randomized controlled trial in which SGB was compared to sham treatment further support the procedure's efficacy (Olmsted et al., 2019). In that study, PTSD symptom reduction in the SGB group was twice as large as the sham group. Research also supports SGB's safety and acceptability among patients with combat-related PTSD (McLean, 2015).
To date, however, the effectiveness of SGB when delivered in combination with first-line PTSD treatments like CPT has not been examined. The present study is designed to examine this issue from two perspectives. First, we will examine if the administration of SGB during CPT leads to larger reductions in PTSD symptoms as compared to CPT alone. Second, we will examine if the administration of SGB after CPT leads to significant reductions in PTSD symptoms among veterans who continue to experience moderate to severe symptoms after completing the therapy. To achieve this the study entails a single-blind, randomized clinical trial with wait list control. All participants will receive cognitive processing therapy (CPT), an empirically-supported psychological (non-medication) treatment for PTSD. Participants will be randomly assigned to receive stellate ganglion block (SGB) treatment at one of two time points: (1) during CPT or (2) three months after completing CPT. Outcomes will be assessed repeatedly for six months postbaseline.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 85
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT) Cognitive Processing Therapy (CPT) Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT. Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT) Stellate Ganglion Block Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT. SGB three months after completing CPT Cognitive Processing Therapy (CPT) Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions. SGB three months after completing CPT Stellate Ganglion Block Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.
- Primary Outcome Measures
Name Time Method 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 PTSD symptom severity will be assessed using PTSD PCL-5. The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.
- Secondary Outcome Measures
Name Time Method Change in good end-state functioning 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 Good end-state functioning is defined as having very low symptoms of both PTSD and depression, and is operationalized as a PCL-5 total score \< 20 and a PHQ-9 total score \< 10. It will be measured using a combination of these scores.
Change in depression 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 Severity will be measured using the Patient Health Questionnaire-9 (PHQ-9). The scale includes 9 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of depression symptom severity.
Change in somatic symptoms 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 Symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15). The PHQ-15 is designed to assess the severity of 15 somatic/physical symptoms using a 3-point scale. Items can be summed to provide an overall metric of somatic symptoms and side effects.
Change in anxiety 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 Severity will be measured using the Generalized Anxiety Disorder-7 (GAD-7) scale. The scale includes 7 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of anxiety symptom severity.
Trial Locations
- Locations (1)
The Ohio State University
šŗšøColumbus, Ohio, United States