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

NCT07021352 | Recruiting

• 1 other identifier: TSNRP N25D272IR
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Emotional Distress; PTSD and Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, post 2-week intervention, post 4-week intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Procedure: Ear acupuncture; Behavioral: Mindfulness therapy

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.

Behavioral: Mindfulness therapy

Interventions

Mindfulness therapy BEHAVIORAL

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

Ear acupuncture plus mindfulness therapy; Mindfulness Therapy Only

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.

Ear acupuncture plus mindfulness therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (2)

David Grant USAF Medical Center

Fairfield, California, 94533, United States

RECRUITING

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Central Study Contacts

Jane Abanes

CONTACT

808-421-9562; jjabanes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 15, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (2)