Clinical trial NCT07021352: Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD
Official title: Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD and Substance Use Disorder
Emotional Distress
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2025-06-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a
timeFrame: Baseline, post 2-week intervention, post 4-week intervention
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5
timeFrame: Baseline, post 2-week intervention, post 4-week intervention
measure: Insomnia Severity Index
timeFrame: Baseline, post 2-week intervention, post 4-week intervention
measure: Alcohol Use Disorders Identification Test
timeFrame: Baseline, post 2-week intervention, post 4-week intervention
measure: Numeric Rating Scale
timeFrame: Baseline, post 2-week intervention, post 4-week intervention
Other outcomes:
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