跳至主要内容
临床试验/NCT05881174
NCT05881174已完成不适用

Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

Malcolm Grow Medical Clinics and Surgery Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年11月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis

研究概览

简要总结

The summary of this research study is to test the effectiveness of a rapid "rescue" acupuncture technique as a non-pharmacologic alternative treatment for the reduction of post-traumatic stress disorder (PTSD) symptoms in affected individuals as a means to improve warfighter health and enable a more rapid return to duty, especially in austere environments. Patients will receive acupuncture as a research-related course of treatment for PTSD. The PCL-5 questionnaire will be used to assess the presence and severity of PTSD symptoms. A PCL-5 questionnaire will be administered at the beginning of the first treatment of "rescue" acupuncture and after the last treatment. Following the acupuncture treatment, a PCL-5 questionnaire will be initiated at the beginning of the first week of treatment and the end of the second week of treatment at the participating Mental Health Clinic (pMHC).

详细描述

"The objective is to treat three ARMS of PTSD patients: ARM 1: Newly untreated diagnosed PTSD patients referred from a participating Mental Health Clinic (pMHC) who have not yet received any PTSD treatment for a 2-week therapy of ""rescue"" acupuncture (six 30 minute sessions Monday, Wednesday, and Friday); ARM 2: Newly diagnosed PTSD patients referred from the pMHC but already placed on pharmacological therapy (i.e. Prazosin, SSRI, sedative, etc.) prior to their enrollment in the pMHC; and ARM 3: newly diagnosed PTSD patients with or without medications referred to pMHC but have a mild traumatic brain injury that does not impede their judgment ability. ARMs 2 and 3 will follow the same ""rescue"" acupuncture program as ARM 1. A PCL-5 questionnaire will be administered prior to and after ""rescue"" acupuncture. ARMs 1, 2, and 3 patients will return to the pMHC (after 2 weeks of ""rescue"" acupuncture) to start or continue pharmacological and/or non-pharmacological therapy(s) and will also be evaluated by a PCL-5 questionnaire at the start and after 2 weeks. Statistical analysis of the PCL-5 questionnaire will compare the three ARMS together as to whether acupuncture is a benefit or not to the patient following therapies received for 2 weeks in the pMHC. The lowering of the PCL-5 symptomatic questionnaire score is a favorable indication of a benefit.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active duty and retired military referred from a participating Mental Health Clinic

排除标准

  • Pregnancy Participated in a form of acupuncture in the last 3 months

研究组 & 干预措施

Newly untreated diagnosed PTSD patients without medications

Active Comparator

Newly untreated diagnosed PTSD patients who have not yet received any PTSD treatment for a 2-week therapy of acupuncture

干预措施: acupuncture (Procedure)

Newly diagnosed PTSD patients on pharmacological therapy

Active Comparator

Newly diagnosed PTSD patients on pharmacological therapy for a 2-week therapy of acupuncture

干预措施: acupuncture (Procedure)

Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury

Active Comparator

Newly diagnosed PTSD patients with or without medications having mild traumatic brain injury for a 2-week therapy of acupuncture

干预措施: acupuncture (Procedure)

结局指标

主要结局

The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis

时间窗: 6 Years

Data will be analyzed using SAS v 9.4. The paired samples t-test will be used to assess the difference in PCL-5 score between pre and post acupuncture treatments. The paired samples t-test will be used to assess the difference in PCL-5 score between pre and post-pharmacological or non-pharmacological treatments. The ANOVA test will be used to assess differences in PCL-5 score between pharmacological, non-pharmacological or both pharmacological and non-pharmacological treatments. Mixed models will be used to assess differences in PCL-5 score between acupuncture treatments and pharmacological. The PCL-5 Analysis-pharmacological or both pharmacological and non-pharmacological treatment scale is a 20-item (0 = not at all, 4 = extremely) self-report measure that assesses the presence and severity of PTSD symptoms. The total severity score (min=0 and Max=80). A PCL-5 score of 31-33 or higher suggests the patient may benefit from PTSD treatment.

次要结局

未报告次要终点

研究者

发起方
Malcolm Grow Medical Clinics and Surgery Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Richard Niemtzow

Lead Principal Investigator

Malcolm Grow Medical Clinics and Surgery Center

研究点 (2)

Loading locations...

相似试验

Rapid Acupuncture Treatment for Post-Traumatic... | 临床试验