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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 2026 to Mar 2, 2026
    v4
  2. Notable Start date: Oct 2025 to Feb 2026v3
  3. Notable Primary endpoint revisedv2 Show 4 more changesShow less
    • Interventions: Ear acupuncture plus mindfulness therapy (Procedure), Mindfulness therapy only (Behavioral) to Ear acupuncture (Procedure), Mindfulness therapy (Behavioral)
    • Secondary endpoints revised (4)
    • Eligibility criteria shortened, about 1 word
    • Study title shortened, about 4 words
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07021352
Lead Sponsor United States Naval Medical Center, San Diego
Conditions
(from sponsor)
PTSD and Substance Use Disorder, Emotional Distress
Related terms Stress Disorders, Post-Traumatic, Substance-Related Disorders
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov