Effects of Acupuncture on Perceived Stress and Health in Military Service Members

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Acupuncture on Perceived Stress and Health in Military Service Members and Veterans

Conditions
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Perceived Stress

Intervention / Treatment
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* Procedure: Manual Standardized Stress Acupuncture (MSSA)
* Behavioral: Mindfulness-Based Stress Reduction (MBSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active duty and veteran service members, 18 to 65 years of age, self-report of perceived stress symptoms for at least one month, a score of 16 or above on the PSS, stable on psychiatric and other medications including blood pressure agents for at least three months, agrees to participate in group psychotherapy (i.e., MBSR), and able to provide informed consent. Exclusion Criteria: Recent surgery within one month, alcohol abuse or dependence diagnosis within one month, active substance use/abuse/dependency treatment within one month, pregnant women (acupuncture can result in an induction of labor and spontaneous abortion on rare occasions), and has had acupuncture treatment, dry needling, and MBSR provided by a provider in the past month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR)<br> | Procedure: Manual Standardized Stress Acupuncture (MSSA)<br>* Participants in the experimental group will receive 4 weekly sessions of MSSA, which consists of 8 acupuncture points: bilateral auricular (ear) shen men, GV- 20, GV-24.5 (Yin Tang), bilateral LI-4, and bilateral LR-3. Needles are left in situ for 30 minutes per session.<br>Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* Participants will receive four sessions of MBSR group psychotherapy (no more than 10 participants per group session) via Microsoft Teams. The first session will be 90 minutes followed by three 60-minute weekly sessions.<br>|
| Active Comparator: Mindfulness-Based Stress Reduction (MBSR)<br> | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* Participants will receive four sessions of MBSR group psychotherapy (no more than 10 participants per group session) via Microsoft Teams. The first session will be 90 minutes followed by three 60-minute weekly sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale (PSS) | The PSS is a 10-item scale used to evaluate perceived stress experience in adults. Perceived general stress is rated on a 5-point Likert-type scale ranging from never to very often. The total possible scores for PSS range from 0 to 56, with higher scores indicating higher stress. | At baseline, at two weeks post interventions, and at four weeks post interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | The ISI is a seven-item standardized self-report questionnaire that measures the subjective symptoms of insomnia. These subjective symptoms include the respondents' concerns and distress because of problems with sleep. The ISI measure contains seven items: perceived difficulty with sleep-onset, sleep maintenance, and early morning awakenings; satisfaction with sleep patterns; interference of sleep problems with daily functioning; impairment because of a sleep problem; and degree of distress or concern with the sleep problem. Each item in the ISI is rated from 0 to 4 whereby the higher number indicates more difficulty. The scores are added to yield a range of total scores from 0 to 28 in which a higher score suggests more severe insomnia. | At baseline, at two weeks post interventions, and at four weeks post interventions | 
| The Short Form (SF) Health Survey | The 20-Item Short Form Health Survey (SF-20) measures the multidimensional concept of health including perceptions about general health, physical health, mental health, and social functioning. Scores are transformed to a scale of 0 to 100 wherein high scores indicate better functioning. | At baseline, at two weeks post interventions, and at four weeks post interventions | 
| Journal Log | Journal entries will include five open-ended questions about the participants' perceived benefits of treatment. | At weeks 2 and 4 after treatments have been completed. |