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Идёт набор NCT07021352

Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD

Без фазы С лечением PTSD and Substance Use Disorder Emotional Distress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ear acupuncture, Mindfulness therapy.
Кому может быть актуально
Состояния в реестре: PTSD and Substance Use Disorder, Emotional Distress. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Процедура 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.
  • Поведенческое Mindfulness therapy
    Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform.

Первичные конечные точки

  • Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a [Срок оценки: Baseline, post 2-week intervention, post 4-week intervention]
Вторичные конечные точки (4)
  • Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5 [Срок оценки: Baseline, post 2-week intervention, post 4-week intervention]
  • Insomnia Severity Index [Срок оценки: Baseline, post 2-week intervention, post 4-week intervention]
  • Alcohol Use Disorders Identification Test [Срок оценки: Baseline, post 2-week intervention, post 4-week intervention]
  • Numeric Rating Scale [Срок оценки: Baseline, post 2-week intervention, post 4-week intervention]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • David Grant USAF Medical Center — Fairfield
  • Naval Medical Center San Diego — San Diego

Идентификаторы

NCT: NCT07021352 · TSNRP N25D272IR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗