Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in PCL-5 (Posttraumatic Stress Disorder Checklist)
研究概览
简要总结
This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.
详细描述
Massed PE will be conducted by 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. The stellate ganglion block injection 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.
During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masked clinical diagnostic assessor for the CAPS-5
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 or retired military service member (age 18- 65 years)
- •PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- •Able to speak and read English (due to standardization of outcome measures)
- •Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.
排除标准
- •Classification as high risk for suicide
- •Current serious mental health diagnosis (e.g., bipolar or psychosis)
- •Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
- •Pregnancy (i.e. positive pregnancy test at screening) 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
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)
结局指标
主要结局
Change in PCL-5 (Posttraumatic Stress Disorder Checklist)
时间窗: Baseline, 1 month and 3 months
A 20-item self-report measure that assesses the presence and severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5).
Change in CAPS-5 (Clinician-Administered PTSD Scale)
时间窗: Baseline, 1 month and 3 months
A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning.
次要结局
- Change in PHQ-9 (Patient Health Questionnaire-9)(Baseline, 1 month and 3 months)
- Change in Brief Inventory of Psychosocial Functioning(Baseline, 1 month and 3 months)
- Change in GAD-7 (General Anxiety Disorder Screener)(Baseline, 1 month and 3 months)
- Change in PTCI (Posttraumatic Cognitions Inventory)(Baseline, 1 month and 3 months)