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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnited States Naval Medical Center, San Diego

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ear acupuncture

    Procedure/Surgery

    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

    Behavioral

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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Ear acupuncture plus mindfulness therapyExperimental treatment 2 interventions
Group B: Mindfulness Therapy OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a

Minimum value= 5, Maximum value = 40; higher scores mean worse outcome

Time frame
Baseline, post 2-week intervention, post 4-week intervention

Secondary outcomes

1

Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5

Minimum value = 0, Maximum value = 80, higher scores mean worse outcome

Time frame
Baseline, post 2-week intervention, post 4-week intervention
2

Insomnia Severity Index

Minimum value= 0, Maximum value = 28; higher scores mean worse outcome

Time frame
Baseline, post 2-week intervention, post 4-week intervention
3

Alcohol Use Disorders Identification Test

Minimum value= 0, Maximum value = 40; higher scores mean worse outcome

Time frame
Baseline, post 2-week intervention, post 4-week intervention
4

Numeric Rating Scale

Minimum value= 0, Maximum value = 10; higher scores mean worse outcome

Time frame
Baseline, post 2-week intervention, post 4-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.