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

NCT ID: NCT07021352

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-06-30

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

PTSD and Substance Use Disorder; Emotional Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ear acupuncture

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness therapy

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: PROCEDURE

Mindfulness therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Jane J. Abanes

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jane Abanes

Role: CONTACT

jjabanes@gmail.com

808-421-9562

Other Identifiers

TSNRP N25D272IR

Identifier Type: -

Identifier Source: org_study_id