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

Perceived Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044714
• Other study ID #: NMCSD.2022.0054
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: United States Naval Medical Center, San Diego
• Contact: Jane Abanes, PhD
• Phone: 415-855-1655
• Email: jjabanes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perceived Stress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	TriService Nursing Research Program, University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Pressure (systolic and diastolic)	Blood pressures will be measured using a vital signs measuring device	Prior to each acupuncture session (experimental group only)
Other	Heart Rate	Heart rate will be measured using a vital signs measuring device	Prior to each acupuncture session (experimental group only)
Other	Defense and Veterans Pain Rating Scale (DVPRS)	The DVPRS measures pain from 0 (no pain) to 10 (as bad as it could be)	Prior to each acupuncture session and at the end of each acupuncture session (experimental group only)
Primary	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	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
Secondary	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
Secondary	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.