Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Официальное название

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.

Подробное описание

Massed PE will be conducted by master-level or doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. Each participant will also be offered three booster sessions at 1-, 3-, and 7-weeks posttreatment.

The stellate ganglion block injection or the sham SGB will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration.

Assessments will be administered at pretreatment, during treatment, at posttreatment, and at 1-, 3-, and 6-months following the completion of PE. The primary outcome assessment will be 1-month following the completion of PE. Following this assessment, participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine.

Вмешательства

• Препарат Ropivacaine injection
  6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
• Препарат Normal saline
  6.5cc of Normal Saline one time into the stellate ganglion.

Первичные конечные точки

• Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5) [Срок оценки: Baseline and at 1-month, 3-month, and 6-month follow-up assessments]
• Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5) [Срок оценки: Baseline and at 1-month, 3-month, and 6-month follow-up assessments]

Вторичные конечные точки (10)

• Patient Health Questionnaire-9 items (PHQ-9) [Срок оценки: Baseline and at 1-month, 3-month, and 6-month follow-up assessments]
• General Anxiety Disorder Screener - 7 Items (GAD-7) [Срок оценки: Baseline and at 1-month, 3-month, and 6-month follow-up assessments]
• Posttraumatic Cognitions Inventory (PTCI) [Срок оценки: Baseline and at 1-month, 3-month, and 6-month follow-up assessments]
• Psychophysiological arousal - Galvanic Skin Response [Срок оценки: Two weeks]
• Psychophysiological arousal - Skin Temperature [Срок оценки: Two weeks]
• Psychophysiological arousal - Heart Rate [Срок оценки: Two weeks]
• Psychophysiological arousal - Interbeat Interval [Срок оценки: Two weeks]
• Psychophysiological arousal - Three-Dimensional Accelerometer Movement [Срок оценки: Two weeks]
• Psychophysiological arousal - Electrodermal Activity [Срок оценки: Two weeks]
• Psychophysiological arousal - Photoplethysmography [Срок оценки: Two weeks]

Критерии участия

Критерии включения

• Active duty and retired military service members ages 18-65 years
• PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
• Able to speak and read English (due to standardization of outcome measures)
• Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.

Критерии исключения

• Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
• Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
• Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
• Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
• Pregnancy or breastfeeding
• Current anticoagulant use
• History of bleeding disorder
• Infection or mass at injection site
• Myocardial infarction within 6 months of procedure
• Pathologic bradycardia or irregularities of heart rate or rhythm
• Symptomatic hypotension
• Phrenic or laryngeal nerve palsy
• History of glaucoma
• Uncontrolled seizure disorder
• History of allergy to local anesthetics
• Current use of Class III antiarrhythmics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Carl R. Darnall Army Medical Center — Fort Hood
• University of Texas Health Science Center at San Antonio — San Antonio

Публикации

• Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2 PMID 29362795
• Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402. PMID 27187898
• 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. PMID 19034755
• 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. PMID 27612365
• 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. PMID 25269132
• Odosso RJ, Petta L. The Efficacy of the Stellate Ganglion Block as a Treatment Modality for Posttraumatic Stress Disorder Among Active Duty Combat Veterans: A Pilot Program Evaluation. Mil Med. 2021 Jul 1;186(7-8):e796-e803. doi: 10.1093/milmed/usaa246. PMID 33242072
• Peterson AL, Blount TH, Foa EB, Brown LA, McLean CP, Mintz J, Schobitz RP, DeBeer BR, Mignogna J, Fina BA, Evans WR, Synett S, Hall-Clark BN, Rentz TO, Schrader C, Yarvis JS, Dondanville KA, Hansen H, Jacoby VM, Lara-Ruiz J, Straud CL, Hale WJ, Shah D, Koch LM, Gerwell KM, Young-McCaughan S, Litz BT, Meyer EC, Blankenship AE, Williamson DE, Roache JD, Javors MA, Sharrieff AM, Niles BL, Keane TM; C PMID 36602803

Идентификаторы

NCT: NCT05889741 · HSC20230087H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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