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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5 | Minimum value = 0, Maximum value = 80, higher scores mean worse outcome | Baseline, post 2-week intervention, post 4-week intervention |
| Insomnia Severity Index |
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Inclusion Criteria:
Exclusion Criteria:
- Has had mindfulness therapy received from a healthcare provider in the past month
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Abanes | Contact | 808-421-9562 | jjabanes@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant USAF Medical Center | Recruiting | Fairfield | California | 94533 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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| Mindfulness therapy | Behavioral | Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform. |
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Minimum value= 0, Maximum value = 28; higher scores mean worse outcome
| Baseline, post 2-week intervention, post 4-week intervention |
| Alcohol Use Disorders Identification Test | Minimum value= 0, Maximum value = 40; higher scores mean worse outcome | Baseline, post 2-week intervention, post 4-week intervention |
| Numeric Rating Scale | Minimum value= 0, Maximum value = 10; higher scores mean worse outcome | Baseline, post 2-week intervention, post 4-week intervention |
| Naval Medical Center San Diego | Recruiting | San Diego | California | 92134 | United States |
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