Behaviors and Mental Disorders

All Conditions

Wounds and Injuries

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Trauma and Stressor Related Disorders

Stress Disorders, Post-Traumatic

Ganglion Cysts

Stress Disorders, Traumatic

Synovial Cyst

Cysts

Psychological Trauma

Mental Disorders

Psychotic Disorders

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Ropivacaine

Anesthetics, Local

Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT.

Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.

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.

Cognitive Processing Therapy (CPT)

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.

Stellate Ganglion Block

Craig J Bryan, PsyD

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.

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.

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.

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

Researchers interested in using IPD and/or computer code collected or generated as part of this study may do so by contacting the study PI. Researchers will be asked to complete a Data Use Request Form, which includes contact information, description of the research project for which the data and/or code would be used, specification of which data and/or code would be needed for their proposed project, an approximate time line for their proposed project, and authorship on their proposed project.

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.

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.

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.

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.

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.

The Stellate Institute

Navy SEAL Foundation

Ohio State University

Stress, Trauma, and Resilience (STAR) Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Active Duty Air Force, Army and Navy women diagnosed with PCOS.

Up to three focus groups per service branch will be conducted. Considering attrition for those who may volunteer and not show up for the FG session, the investigators will recruit up to 20 participants per site, with the goal of including a maximum of six participants per FG to maximize individual participation.

No intervention

Dawnkimberly Hopkins, PhD

Leilani Siaki, PhD

Abigail Yablonsky, PhD

Angela Phillips, PhD

The purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population.

Using a qualitative descriptive approach with focus groups (FG) and individual interviews (II), the investigators will seek to describe the experience of living with PCOS as an active duty service woman (ADSW). This method will allow the investigators to obtain a comprehensive summary of living with PCOS in the every day terms of ADSW. The discussion in the (FG) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. Advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest \[64, 65\].

This proposed study will focus on six primary areas of inquiry: (a) experience of receiving PCOS diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with PCOS, (d) access to/availability of information related to PCOS and how they have applied it, (e) experience of support, and (f) present and future concerns about having PCOS.

The Experience of Living With Polycystic Ovary Syndrome in the Military

Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences of active duty service members

Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences by branch of service

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD	NCT05107752	PTSD Trauma and Stre... Trauma, Psychol... Post Traumatic ...	Cognitive Proce... Stellate Gangli...	18 Years -	Ohio State University
The Experience of Living With Polycystic Ovary Syndrome in the Military	NCT03876665	Polycystic Ovar...	No intervention	18 Years -	David Grant U.S. Air Force Medical Center

Spots Global Cancer Trial Database for military

Every month we try and update this database with for military cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for military

Every month we try and update this database with for military cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for military cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.