Acupuncture for the Treatment of Trauma Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- PTSD Checklist (PCL)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of acupuncture as a treatment for Posttraumatic Stress Disorder (PTSD) among military personnel.
详细描述
Untreated Posttraumatic Stress Disorder (PTSD) leads to decreased force readiness and increased health care utilization. Yet, service members with the disorder may be resistant to traditional treatments or find them undesirable because of side-effects, stigma, and long-term commitment. Acupuncture, which has few known side effects, holds promise as an effective treatment option for PTSD. Acupuncture has been shown to improve well-being and has been successfully used to treat stress, anxiety and pain conditions. In order to test the efficacy of acupuncture for treating the symptoms of PTSD-measured by the PTSD Checklist (PCL)-a 12-week, randomized, waitlist-controlled trial will be conducted using a sample of 75 active duty military personnel. Participants will receive an eight-session acupuncture treatment, and will be evaluated throughout the study by way of clinical assessments and an independent assessing acupuncturist.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active duty military personnel
- •Criteria met for PTSD based on Clinician-Administered PTSD Scale (CAPS) interview
- •A stable medication dosing regimen or therapeutic treatment schedule for at least eight (8) weeks prior to beginning the study.
排除标准
- •Acupuncture treatment within the previous 6 months
- •Pain greater than or equal to level 8 on the Numeric Rating Scale for Pain
- •Significant head injury with loss of consciousness greater than 1 hour
- •Uncontrolled diabetes mellitus: fasting blood glucose >180 mg/dl
- •Unstable or uncontrolled endocrine disorders, thyroid disease, renal failure, anemia, hemorrhagic diathesis, renovascular disease, Cushing's disease, or hyperaldosteronism
- •Unwillingness on the part of participants to complete all study visits and/or the daily Life Chart
- •Pregnancy
- •Scheduled surgery during the treatment phase of the study
- •Medical instability sufficient to warrant inpatient treatment in the medical or intensive care units
- •Psychiatric symptoms sufficient to warrant inpatient treatment by the clinical care team
- •Psychosis within the past two years
- •A traumatic experience, as defined by the DSM-IV criterion A for ASD/PTSD, within the past 30 days
结局指标
主要结局
PTSD Checklist (PCL)
时间窗: baseline, 1 month, 2 months, and 3 months
The PCL is a widely used measure of PTSD symptom presence and severity among veterans. It is a 17-item measure that assesses the symptoms of PTSD listed in the DSM-IV. Respondents indicate on a 5-point scale (1-5) the degree to which they have been bothered by each symptom in the past month. The PCL-M yields a total severity score ranging from 17 to 85.
次要结局
- Clinician-Administered PTSD Scale(baseline, 3 months)
- The Trauma History Questionnaire(baseline, 3 months)
- SF-36-Revised(baseline, 3 months)
- Beck Depression Inventory(baseline, 1 month, 2 months, 3 months)
- Numeric Rating Scale for Pain(baseline, 1 month, 2 months, 3 months)
- PTSD Life Chart Method (PTSD-LCM)(tracked daily throughout 3-month study period)
- Alcohol Use Disorder Identification Test(baseline, 3 months)
- Diagnostic evaluation by blind assessing acupuncturist(baseline, 1 month)
研究者
Charles Engel
Dir, Deployment Health Clinical Center, WRNMMC; Associate Professor, psychiatry, USUHS
Uniformed Services University of the Health Sciences