Emotional Distress, PTSD and Substance Use Disorder
Conditions
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.
Interventions
PROCEDUREEar 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.
BEHAVIORALMindfulness therapy
Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform.
Sponsors
United States Naval Medical Center, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a | Baseline, post 2-week intervention, post 4-week intervention | Minimum value= 5, Maximum value = 40; higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5 | Baseline, post 2-week intervention, post 4-week intervention | Minimum value = 0, Maximum value = 80, higher scores mean worse outcome |
| Insomnia Severity Index | Baseline, post 2-week intervention, post 4-week intervention | Minimum value= 0, Maximum value = 28; higher scores mean worse outcome |
| Alcohol Use Disorders Identification Test | Baseline, post 2-week intervention, post 4-week intervention | Minimum value= 0, Maximum value = 40; higher scores mean worse outcome |
| Numeric Rating Scale | Baseline, post 2-week intervention, post 4-week intervention | Minimum value= 0, Maximum value = 10; higher scores mean worse outcome |
Countries
United States
Contacts
CONTACTJane Abanes
Outcome results
None listed