Acupuncture + Mindfulness Therapy for Perceived Stress

Overseen By Jane Abanes, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Disqualifiers: Recent surgery, Alcohol abuse, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been stable on psychiatric and other medications, including blood pressure agents, for at least three months.

What data supports the effectiveness of this treatment for perceived stress?

Research shows that manual standardized stress acupuncture (MSSA) combined with cognitive behavioral therapy (CBT) improved sleep and other life areas like mental and social functioning in military service members. Additionally, traditional Chinese acupuncture (TCA) has been explored for treating chronic stress, and auricular acupuncture (AA) has shown benefits for anxiety, which may relate to stress reduction. ^{1 2 3 4 5}

Is acupuncture safe for stress and related conditions?

Acupuncture is generally considered safe, with mild side effects being common. Studies have shown it to be acceptable and feasible for use in military personnel with perceived stress, and it has been used safely in various conditions, including sleep disturbances. ^{1 5 6 7 8}

How does the Acupuncture + Mindfulness Therapy treatment for perceived stress differ from other treatments?

This treatment is unique because it combines acupuncture, a traditional practice involving the insertion of thin needles into specific points on the body, with mindfulness therapy, which focuses on being present and aware to reduce stress. While mindfulness-based stress reduction (MBSR) alone has shown benefits in reducing stress and improving well-being, the addition of acupuncture may enhance these effects by addressing both physical and mental aspects of stress. ^{9 10 11 12 13}

What is the purpose of this trial?

The goal of this is to investigate the effect of a Manual Standardized Stress Acupuncture (MSSA) protocol as an adjunct treatment to a short-term mindfulness therapy for perceived stress and general health in service members (i.e., active duty military personnel and veterans). The specific aims of this study are Aim 1) To evaluate the effectiveness of a brief MSSA as an adjunct treatment with a short-term Mindfulness-Based Stress Reduction (MBSR) compared with MBSR alone for perceived stress and general health in service members. Aim 2) To describe any perceived benefits of MSSA as an adjunct treatment with MBSR compared with MBSR alone for perceived stress and general health. Participants will be asked to complete an informed consent if eligible for the study and randomized into two groups: 1) Participants in the experimental group will receive MSSA in addition to MBSR. 2) Participants in the control group will receive MBSR only. Researchers will compare experimental and control groups to see if the interventions mitigated perceived stress and improved the health of the participants.

Eligibility Criteria

This trial is for active duty and veteran service members aged 18-65 who feel stressed for at least a month, score 16+ on the Perceived Stress Scale (PSS), have stable medication use for three months, and are willing to try group therapy.

Inclusion Criteria

You are an active member or veteran of the military.

I am between 18 and 65 years old and have felt stressed for at least a month.

You have attained a score of 16 or higher on the Perceived Stress Scale.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR) or MBSR alone

4 weeks

Weekly sessions

Follow-up

Participants are monitored for perceived stress and health outcomes after treatment

4 weeks

Assessments at 2 and 4 weeks post-intervention

Treatment Details

Interventions

• Manual Standardized Stress Acupuncture (MSSA)

Trial Overview The study tests if Manual Standardized Stress Acupuncture (MSSA) alongside Mindfulness-Based Stress Reduction (MBSR) helps reduce stress more than MBSR alone in military personnel. Participants will be randomly assigned to either receive both treatments or just MBSR.

Participant Groups

Group I: Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR) Experimental Treatment 2 Interventions

Group II: Mindfulness-Based Stress Reduction (MBSR) Active Control 1 Intervention

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

TriService Nursing Research Program

Collaborator

Trials

10

Recruited

810+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Findings from Research

Service members who received a combination of cognitive-behavioral therapy for insomnia (CBTi) and manual standardized stress acupuncture (MSSA) reported greater improvements in sleep quality and overall life functioning compared to those who only received CBTi.

The study highlights the potential benefits of MSSA as an adjunct treatment for sleep disturbances, suggesting that it may enhance mental, physical, and social well-being in postdeployment service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived benefits of brief acupuncture for sleep disturbances in postdeployment military service members. Abanes, J., Ridner, SH., Rhoten, B.[2022]

In a pilot study with 18 adult volunteers experiencing high stress, traditional Chinese acupuncture (TCA) showed potential to normalize the cortisol awakening response, suggesting a reduction in stress levels after 5 weeks of treatment.

However, the observed effects of TCA were not statistically significant compared to a control group receiving only attention, indicating that further research with a larger sample size is needed to confirm the efficacy of TCA in stress reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study. Huang, W., Taylor, A., Howie, J., et al.[2019]

Auricular acupuncture and extended auricular therapy can effectively help with pain and anxiety, but using embedded needles poses significant safety risks, including infections and chondritis, as highlighted by 19 adverse event case reports and multiple safety reviews.

Extended auricular therapy using non-invasive methods, like applying natural seeds, offers similar clinical benefits without the risks associated with embedded needles, suggesting a need for further research to determine the necessity of needle use in auricular treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Nielsen, A., Gereau, S., Tick, H.[2021]

In a study involving 30 healthy volunteers, vibro-acupuncture (VA) produced significantly higher sensations compared to non-penetrating sham acupuncture (SA), indicating its potential to enhance the effects of traditional acupuncture methods.

Both manual acupuncture (MA) and VA were associated with higher stimulation responses than SA, but there was no significant difference in sensation between MA and VA, suggesting that while VA offers unique vibrational sensations, its overall efficacy may be similar to that of MA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing vibro-acupuncture: a psychophysical study. Wang, K., Larsen, DB., Jensen, TK., et al.[2017]

Both the brief manual standardized stress acupuncture (MSSA) combined with abbreviated Cognitive Behavioral Therapy (ACBT) and ACBT alone showed similar improvements in insomnia severity, indicating that both interventions are effective for sleep issues.

Participants in the ACBT/MSSA group reported greater overall benefits in sleep quality and other aspects of life, such as mental and social functioning, suggesting that combining acupuncture with therapy may enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members: A Randomized Controlled Trial. Abanes, JJ., Ridner, SH., Dietrich, MS., et al.[2022]

The study demonstrated that standardized stress acupuncture (SSA) is feasible and acceptable for U.S. military personnel experiencing perceived stress, with successful recruitment and implementation in a sample of 16 participants.

Participants showed significant improvements in perceived stress and overall health, including increased energy, well-being, and social functioning, indicating that SSA may be an effective intervention for managing stress in military settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Brief Acupuncture Intervention for Service Members with Perceived Stress. Abanes, J., Hiers, C., Rhoten, B., et al.[2021]

The study developed and tested the AcupAE, a 20-item scale for reporting acupuncture-related adverse events (AEs), which was shown to be more effective than open-ended questioning in detecting AEs across different acupuncture treatments in a sample of 150 adults.

The incidence of AEs was significantly higher when assessed with the AcupAE, with 42.4% for acupuncture and 42.2% for minimal acupuncture, compared to only 16.7% for placebo, highlighting the importance of using standardized instruments for accurate AE reporting in acupuncture research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Acupuncture: Development and Testing of a Rating Scale. Chung, KF., Yeung, WF., Yu, YM., et al.[2016]

Electroacupuncture significantly improved sleep quality and reduced stress-related symptoms such as anxiety and depression in medical students, with 75% of treated students reporting good sleep quality compared to only 23.1% in the control group.

The treatment also led to notable improvements in emotional exhaustion and cynicism related to burnout, indicating its potential as a therapeutic intervention for stress management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture on stress-related symptoms in medical students: a randomised controlled pilot study. Dias, M., Pagnin, D., de Queiroz Pagnin, V., et al.[2015]

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

An 8-week mindfulness-based stress reduction (MBSR) program significantly improved pain perception, quality of life, coping with pain, anxiety, and depression in 58 female fibromyalgia patients, with effect sizes ranging from 0.40 to 1.10.

A 3-year follow-up of 26 participants showed that the benefits of MBSR were sustained over time, with effect sizes between 0.50 and 0.65, indicating its potential for long-term positive impact on well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. Grossman, P., Tiefenthaler-Gilmer, U., Raysz, A., et al.[2019]

Mindfulness-Based Stress Reduction (MBSR) group therapy significantly reduced perceived stress in 30 vulnerable women after eight 90-minute sessions, with post-intervention scores showing a notable decrease from 38.16 to 30.20 on the Perceived Stress Scale.

In contrast, the control group, which did not receive the intervention, showed no significant change in stress levels, highlighting the effectiveness of MBSR in providing psychological support to vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using mindfulness-based stress reduction group therapy to reduce perceived stress of vulnerable women in south of Iran. Khodabandeh Shahraki, S., Adelian, H., Miri, S., et al.[2023]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

In a study of 108 participants with social anxiety disorder, cognitive-behavioral group therapy (CBGT) was found to be more effective than mindfulness-based stress reduction (MBSR) for individuals with higher levels of anger suppression, leading to greater reductions in social anxiety.

Conversely, higher anger expression was linked to less reduction in social anxiety during MBSR, suggesting that individuals with SAD who struggle with anger might benefit more from CBGT than MBSR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. Kuo, JR., Zeifman, RJ., Morrison, AS., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Perceived benefits of brief acupuncture for sleep disturbances in postdeployment military service members. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Introducing vibro-acupuncture: a psychophysical study. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members: A Randomized Controlled Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Brief Acupuncture Intervention for Service Members with Perceived Stress. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Acupuncture: Development and Testing of a Rating Scale. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture on stress-related symptoms in medical students: a randomised controlled pilot study. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Using mindfulness-based stress reduction group therapy to reduce perceived stress of vulnerable women in south of Iran. [2023]

12. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. [2021]