Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The clinical staff, research staff, and the participant will be blind to study condition until after the 1-month follow-up assessment. After which time, the blind will be broken, and participants in the control condition will be offered the SGB.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Stellate Ganglion Block
One time administration of a stellate ganglion block
干预措施: Ropivacaine injection (Drug)
Sham SGB
One time administration
干预措施: Normal saline (Drug)
结局指标
主要结局
Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)
时间窗: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis.
Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)
时间窗: Baseline and at 1-month, 3-month, and 6-month follow-up assessments
A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity.
次要结局
- General Anxiety Disorder Screener - 7 Items (GAD-7)(Baseline and at 1-month, 3-month, and 6-month follow-up assessments)
- Psychophysiological arousal - Galvanic Skin Response(Two weeks)
- Posttraumatic Cognitions Inventory (PTCI)(Baseline and at 1-month, 3-month, and 6-month follow-up assessments)
- Psychophysiological arousal - Heart Rate(Two weeks)
- Psychophysiological arousal - Photoplethysmography(Two weeks)
- Psychophysiological arousal - Skin Temperature(Two weeks)
- Psychophysiological arousal - Electrodermal Activity(Two weeks)
- Patient Health Questionnaire-9 items (PHQ-9)(Baseline and at 1-month, 3-month, and 6-month follow-up assessments)
- Psychophysiological arousal - Interbeat Interval(Two weeks)
- Psychophysiological arousal - Three-Dimensional Accelerometer Movement(Two weeks)