跳至主要内容
临床试验/NCT07021352
NCT07021352招募中不适用

Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder

United States Naval Medical Center, San Diego2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
2
主要终点
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a

研究概览

简要总结

Emotional distress (ED) refers to a state of mental suffering that significantly impairs an individual's ability to cope, often leading to a decline in overall well-being. In military contexts, ED is a prevalent concern due to the unique and demanding challenges faced by military personnel both in combat zones and during peacetime. The primary objective of this study is to assess the efficacy of integrating ear acupuncture with mindfulness therapy in mitigating ED and alleviating post-traumatic stress disorder (PTSD) symptoms among military personnel. The study will examine the effects of auricular acupuncture (AA) and mindfulness therapy (MT) on ED in military personnel with PTSD. The NADA ear acupuncture protocol will be administered using acupuncture semi-permanent (ASP), sterile needles placed in the bilateral ears, which will remain in place until they naturally fall out. Mindfulness therapy will incorporate relaxation techniques, such as yoga and controlled breathing exercises, specifically designed to alleviate ED. A mixed-methods approach, integrating both quantitative and qualitative methods, will be employed concurrently to evaluate the interventions' effectiveness and to explore the participants' perceived benefits. Specific Aim 1: To evaluate the effectiveness and perceived benefits of the National Acupuncture Detoxification Association (NADA) ear acupuncture protocol as an adjunct therapy to brief mindfulness therapy for reducing emotional distress in service members and veterans with PTSD. Specific Aim 2: To examine the effectiveness of NADA as an adjunct therapy to brief mindfulness therapy in improving sleep disturbances, alcohol use, and pain in service members and 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
None

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
否

入选标准

  • •Active duty service member and veterans
  • •A score of 14 or above on the abbreviated PCL 6-item
  • •A score of 24 or above on the EDS
  • •Agrees to participate in mindfulness therapy
  • •Able to provide informed consent

排除标准

  • •- Has had mindfulness therapy received from a healthcare provider in the past month

研究组 & 干预措施

Ear acupuncture plus mindfulness therapy

Experimental

Arm A (Ear Acupuncture plus Mindfulness): Participants will receive bilateral NADA ear acupuncture protocol treatment for a one-time insertion in addition to the weekly mindfulness therapy received by participants. The NADA consists of 5 ear acupuncture points inserted bilaterally: shen men, sympathetic, kidney, liver, and lung. Sterile, semi-permanent acupuncture needles (2mm) will be inserted into the participant's ear and left in place until they naturally fall out, typically within 3-7 days. This group will also receive mindfulness weekly for 30 minutes each session via the MS Teams platform.

干预措施: Mindfulness therapy (Behavioral)

Ear acupuncture plus mindfulness therapy

Experimental

Arm A (Ear Acupuncture plus Mindfulness): Participants will receive bilateral NADA ear acupuncture protocol treatment for a one-time insertion in addition to the weekly mindfulness therapy received by participants. The NADA consists of 5 ear acupuncture points inserted bilaterally: shen men, sympathetic, kidney, liver, and lung. Sterile, semi-permanent acupuncture needles (2mm) will be inserted into the participant's ear and left in place until they naturally fall out, typically within 3-7 days. This group will also receive mindfulness weekly for 30 minutes each session via the MS Teams platform.

干预措施: Ear acupuncture (Procedure)

Mindfulness Therapy Only

Active Comparator

Arm B (Mindfulness only): The mindfulness-only group will receive mindfulness therapy weekly. Participants in arm B will receive virtual mindfulness weekly for 30 minutes each session via the MS Teams platform.

干预措施: Mindfulness therapy (Behavioral)

结局指标

主要结局

Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a

时间窗: Baseline, post 2-week intervention, post 4-week intervention

Minimum value= 5, Maximum value = 40; higher scores mean worse outcome

次要结局

  • Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5(Baseline, post 2-week intervention, post 4-week intervention)
  • Insomnia Severity Index(Baseline, post 2-week intervention, post 4-week intervention)
  • Alcohol Use Disorders Identification Test(Baseline, post 2-week intervention, post 4-week intervention)
  • Numeric Rating Scale(Baseline, post 2-week intervention, post 4-week intervention)

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Jane J. Abanes

Assistant Professor

United States Naval Medical Center, San Diego

研究点 (2)

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