Clinical trial NCT05107752: Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD
Official title: Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: PTSD
Trauma and Stressor Related Disorders
Trauma, Psychological
Post Traumatic Stress Disorder
Keywords: veteran
military
stellate ganglion block
cognitive processing therapy
cognitive behavioral therapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: The Stellate Institute
name: Navy SEAL Foundation
First posted: 2021-11-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in PTSD symptom severity
timeFrame: 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
Secondary outcomes:
measure: Change in depression symptom severity
timeFrame: 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
measure: Change in anxiety symptom severity
timeFrame: 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
measure: Change in somatic symptoms
timeFrame: 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
measure: Change in good end-state functioning
timeFrame: 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
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Craig J Bryan, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alino J, Kosatka D, McLean B, Hirsch K. Efficacy of stellate ganglion block in the treatment of anxiety symptoms from combat-related post-traumatic stress disorder: a case series. Mil Med. 2013 Apr;178(4):e473-6. doi: 10.7205/MILMED-D-12-00386.
citation: Harik, J. M., Grubbs, K. G., & Schnurr, P. P. (2016, November). Using graphics to communicate information about PTSD treatment effectiveness to patients. In J. L. Hamblen (Chair), Enhancing the quality of online information to support PTSD treatment engagement. Symposium presented at the 30th annual meeting of the International Society for Traumatic Stress Studies in Dallas, TX.
citation: Hicky A, Hanling S, Pevney E, Allen R, McLay RN. Stellate ganglion block for PTSD. Am J Psychiatry. 2012 Jul;169(7):760. doi: 10.1176/appi.ajp.2012.11111729. No abstract available.
citation: Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
citation: Hoge CW, Terhakopian A, Castro CA, Messer SC, Engel CC. Association of posttraumatic stress disorder with somatic symptoms, health care visits, and absenteeism among Iraq war veterans. Am J Psychiatry. 2007 Jan;164(1):150-3. doi: 10.1176/ajp.2007.164.1.150.
citation: Jakupcak M, Conybeare D, Phelps L, Hunt S, Holmes HA, Felker B, Klevens M, McFall ME. Anger, hostility, and aggression among Iraq and Afghanistan War veterans reporting PTSD and subthreshold PTSD. J Trauma Stress. 2007 Dec;20(6):945-54. doi: 10.1002/jts.20258.
citation: Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.
citation: Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518.
citation: McLean B. Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. Cureus. 2015 Sep 10;7(9):e320. doi: 10.7759/cureus.320.
citation: Milliken CS, Auchterlonie JL, Hoge CW. Longitudinal assessment of mental health problems among active and reserve component soldiers returning from the Iraq war. JAMA. 2007 Nov 14;298(18):2141-8. doi: 10.1001/jama.298.18.2141.
citation: Mulvaney SW, Curtis KE, Ibrahim TS (2020) Comparison C6 Stellate Ganglion versus C6 and C4 Cervical Sympathetic Chain Blocks for Treatment of Posttraumatic Stress Disorder (PTSD): Analysis of 147 Patients. J Neurol Disord Stroke 7(3): 1163.
citation: Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.
citation: Mulvaney SW, McLean B, de Leeuw J. The use of stellate ganglion block in the treatment of panic/anxiety symptoms with combat-related post-traumatic stress disorder; preliminary results of long-term follow-up: a case series. Pain Pract. 2010 Jul-Aug;10(4):359-65. doi: 10.1111/j.1533-2500.2010.00373.x. Epub 2010 Apr 20.
citation: Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
citation: Panagioti M, Gooding P, Tarrier N. Post-traumatic stress disorder and suicidal behavior: A narrative review. Clin Psychol Rev. 2009 Aug;29(6):471-82. doi: 10.1016/j.cpr.2009.05.001. Epub 2009 Jun 8.
citation: Tanielian, T., & Jaycox, L.H. (2008). Invisible Wounds of War. Rand Corporation, 1-66.
citation: Watts BV, Schnurr PP, Mayo L, Young-Xu Y, Weeks WB, Friedman MJ. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry. 2013 Jun;74(6):e541-50. doi: 10.4088/JCP.12r08225.