PTSD and Substance Use DisorderNCT07021352
Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD
A study testing Ear acupuncture and Mindfulness therapy in people with PTSD and Substance Use Disorder and Emotional Distress, run by United States Naval Medical Center, San Diego at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD and Substance Use Disorder, Emotional Distress
- What is being tested?
- Ear acupuncture and Mindfulness therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has had mindfulness therapy received from a healthcare provider in the past month
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
David Grant USAF Medical Center
Fairfield, California, 94533
Jocelyn Caballero, 628-399-0925, jocelyn.caballero@ucsf.edu
- Recruiting
Naval Medical Center San Diego
San Diego, California, 92134
Jocelyn Caballero, 628-399-0925, jocelyn.caballero@ucsf.edu
About this study
Official title: Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder
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.
- Being tested
- Ear acupuncture, Mindfulness therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear acupunctureProcedure or 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 therapyBehavioural
Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ear acupuncture; Behavioral: Mindfulness therapy |
| 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. Receives: Behavioral: Mindfulness therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a
Minimum value= 5, Maximum value = 40; higher scores mean worse outcome
Measured: Baseline, post 2-week intervention, post 4-week intervention
Secondary outcomes (4)
Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5
Minimum value = 0, Maximum value = 80, higher scores mean worse outcome
Measured: Baseline, post 2-week intervention, post 4-week intervention
Insomnia Severity Index
Minimum value= 0, Maximum value = 28; higher scores mean worse outcome
Measured: 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
Measured: Baseline, post 2-week intervention, post 4-week intervention
Numeric Rating Scale
Minimum value= 0, Maximum value = 10; higher scores mean worse outcome
Measured: Baseline, post 2-week intervention, post 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start2 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD and Substance Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jane J. Abanes, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021352
- Sponsor's protocol ID
- TSNRP N25D272IR
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07021352
- Acronym / sponsor ID
- TSNRP N25D272IR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ear acupuncture plus mindfulness therapy | Experimental | Procedure: Ear acupuncture, Behavioral: Mindfulness therapyArm 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. |
| Mindfulness Therapy Only | Active comparator | Behavioral: Mindfulness therapyArm 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Has had mindfulness therapy received from a healthcare provider in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear acupunctureEar 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. | Procedure or surgery | Ear acupuncture plus mindfulness therapy |
| Mindfulness therapyMindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform. | Behavioural | Ear acupuncture plus mindfulness therapy, Mindfulness Therapy Only |
Primary outcome
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a
Time frame: Baseline, post 2-week intervention, post 4-week intervention
Minimum value= 5, Maximum value = 40; higher scores mean worse outcome
4 secondary outcomes
Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5
Time frame: Baseline, post 2-week intervention, post 4-week intervention
Insomnia Severity Index
Time frame: Baseline, post 2-week intervention, post 4-week intervention
Alcohol Use Disorders Identification Test
Time frame: Baseline, post 2-week intervention, post 4-week intervention
Numeric Rating Scale
Time frame: Baseline, post 2-week intervention, post 4-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PTSD and Substance Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruiting
RISE for PTSD and Substance Use Disorder in Veterans
Stress Disorders, Post-Traumatic, Substance-Related Disorders
Recruiting
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
Post Traumatic Stress Disorder, Obstructive Sleep Apnea
RecruitingPhase 2
Suvorexant for Treatment of AUD and PTSD
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear acupuncture and Mindfulness therapy in people with PTSD and Substance Use Disorder and Emotional Distress, run by United States Naval Medical Center, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Abanes (808-421-9562, jjabanes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a (time frame: Baseline, post 2-week intervention, post 4-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.