NCT02871076Unknown不适用
Acupuncture for Post-Traumatic Stress in Combat Veterans
Southern California Institute for Research and Education2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年5月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis
研究概览
简要总结
The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veteran Age 18 to 55
- •DSM-5 criteria for chronic PTSD on Clinical Administered PTSD Scale (CAPS-5)
- •CAPS-5 score of ≥ 26 and meeting criteria for each of 4 symptoms
排除标准
- •Current and past six-months psychosis
- •Substance dependence within 6 months (evidence of tolerance and/or withdrawal)
- •Thyroid disease
- •Decisional incapacity (e.g., dementia)
- •Centrally acting medications that have a potential effect on biological expression (e.g., beta-blockers, opiates, and ≥10mg equivalent of diazepam/day)
- •Pain levels requiring opiate medications
- •Known exposure to chemicals or physical trauma that cause neuropsychiatric sequelae
- •Severe depression (Beck Depression Inventory-II score ≥30)
- •A diagnosed and untreated sleep breathing disorder (SBD)
- •High risk of a SBD as indicated by snoring ≥50 of nights plus one of any
- •Any witnessed apnea
- •Feeling non-refreshed in the morning ≥50 of mornings
- •Daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading
- •Non-response to ≥2 evidence-based PTSD treatments (adequate medication of 12 weeks or completion to PE, CPT or an intensive program)
- •Treatment non-adherence indicated by stopping treatment or >3 missed appointments in the course of PTSD EBT
- •High dissociation as indicated by a score of ≥25 on the Dissociative Experiences Scale - II
- •Past chronic PTSD prior to military service
- •Current active psychotherapy for PTSD
- •Having acupuncture in the past year
- •Pregnancy
结局指标
主要结局
Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis
时间窗: 4 months: Baseline CAPS to post treatment
次要结局
未报告次要终点
研究者
Michael Hollifield, MD
Director, Program for Traumatic Stress
Southern California Institute for Research and Education
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Acupuncture for the Treatment of Posttraumatic Stress Among Military PersonnelPosttraumatic Stress Disorder (PTSD)NCT00320138Henry M. Jackson Foundation for the Advancement of Military Medicine55
已完成
不适用
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)Stress Disorders, Post-TraumaticNCT00055354National Center for Complementary and Integrative Health (NCCIH)90
已完成
不适用
Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSDPost-traumatic Stress DisordersNCT01060553US Department of Veterans Affairs34
已完成
不适用
Auricular Acupuncture for The Treatment of Post-Tonsillectomy PainRecurrent TonsillitisObstructive Sleep ApneaPeritonsillar AbscessNCT01790477United States Naval Medical Center, San Diego134
已完成
不适用
Rapid Acupuncture Treatment for Post-Traumatic Stress DisorderPTSDNCT05881174Malcolm Grow Medical Clinics and Surgery Center24