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

Naval Medical Center

Status: Not yet enrolling

Conditions: Emotional Distress; PTSD and Substance Use Disorder

Treatments: Behavioral: Mindfulness therapy; Procedure: Ear acupuncture

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07021352

TSNRP N25D272IR

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Ear acupuncture plus mindfulness therapy

Experimental group

Description:

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.

Treatment:

Procedure: Ear acupuncture

Behavioral: Mindfulness therapy

Mindfulness Therapy Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness therapy