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

Part of paid clinical trials in Fairfield, California.

Sponsor
United States Naval Medical Center, San Diego
Study ID
NCT07021352
Status
Recruiting

Conditions

  • Emotional Distress
  • PTSD and Substance Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ear acupuncture — PROCEDURE
    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.
  • Mindfulness therapy — BEHAVIORAL
    Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform.

Study Details

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.

Key Dates

Start date
Mar 2, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ear acupuncture plus mindfulness therapy
    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.
  • Active Comparator: Mindfulness Therapy Only
    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.

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a [ Time Frame: Baseline, post 2-week intervention, post 4-week intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
David Grant USAF Medical CenterFairfieldCalifornia94533
Jocelyn Caballero
628-399-0925
Naval Medical Center San DiegoSan DiegoCalifornia92134
Jocelyn Caballero
628-399-0925

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