Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ear acupuncture, Mindfulness therapy.
- Who it may be relevant to
- Registry conditions: PTSD and Substance Use Disorder, Emotional Distress. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder
Overview
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.
Interventions
- Procedure Ear acupuncture
Ear Acupuncture: 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. - Behavioral Mindfulness therapy
Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform.
Primary outcome measures
- Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a [Time frame: Baseline, post 2-week intervention, post 4-week intervention]
Secondary outcome measures (4)
- Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5 [Time frame: Baseline, post 2-week intervention, post 4-week intervention]
- Insomnia Severity Index [Time frame: Baseline, post 2-week intervention, post 4-week intervention]
- Alcohol Use Disorders Identification Test [Time frame: Baseline, post 2-week intervention, post 4-week intervention]
- Numeric Rating Scale [Time frame: Baseline, post 2-week intervention, post 4-week intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
\- Has had mindfulness therapy received from a healthcare provider in the past month
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- David Grant USAF Medical Center — Fairfield
- Naval Medical Center San Diego — San Diego
Identifiers
NCT: NCT07021352 · TSNRP N25D272IR