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

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ClinicalTrials.gov Identifier: NCT06044714
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : March 21, 2024
Sponsor:
Collaborators:
TriService Nursing Research Program
University of California, San Francisco
Information provided by (Responsible Party):
Jane J. Abanes, United States Naval Medical Center, San Diego

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Perceived Stress Procedure: Manual Standardized Stress Acupuncture (MSSA) Behavioral: Mindfulness-Based Stress Reduction (MBSR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Acupuncture on Perceived Stress and Health in Military Service Members and Veterans
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR) Procedure: Manual Standardized Stress Acupuncture (MSSA)
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.

Behavioral: Mindfulness-Based Stress Reduction (MBSR)
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.
Active Comparator: Mindfulness-Based Stress Reduction (MBSR) Behavioral: Mindfulness-Based Stress Reduction (MBSR)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Perceived Stress Scale (PSS) [ Time Frame: At baseline, at two weeks post interventions, and at four weeks post interventions ]
    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.


Secondary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: At baseline, at two weeks post interventions, and at four weeks post interventions ]
    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.

  2. The Short Form (SF) Health Survey [ Time Frame: At baseline, at two weeks post interventions, and at four weeks post interventions ]
    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.

  3. Journal Log [ Time Frame: At weeks 2 and 4 after treatments have been completed. ]
    Journal entries will include five open-ended questions about the participants' perceived benefits of treatment.


Other Outcome Measures:
  1. Blood Pressure (systolic and diastolic) [ Time Frame: Prior to each acupuncture session (experimental group only) ]
    Blood pressures will be measured using a vital signs measuring device

  2. Heart Rate [ Time Frame: Prior to each acupuncture session (experimental group only) ]
    Heart rate will be measured using a vital signs measuring device

  3. Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Prior to each acupuncture session and at the end of each acupuncture session (experimental group only) ]
    The DVPRS measures pain from 0 (no pain) to 10 (as bad as it could be)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044714


Contacts
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Contact: Jane Abanes, PhD 415-855-1655 jjabanes@gmail.com

Sponsors and Collaborators
United States Naval Medical Center, San Diego
TriService Nursing Research Program
University of California, San Francisco
More Information
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Responsible Party: Jane J. Abanes, Principal Investigator, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT06044714    
Other Study ID Numbers: NMCSD.2022.0054
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No