NCT06044714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 28, 2026

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

September 8, 2023

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Insomnia Severity Index

    At baseline, at two weeks post interventions, and at four weeks post interventions

  • The Short Form (SF) Health Survey

    At baseline, at two weeks post interventions, and at four weeks post interventions

  • Journal Log

    At weeks 2 and 4 after treatments have been completed.

Other Outcomes (3)

  • Blood Pressure (systolic and diastolic)

    Prior to each acupuncture session (experimental group only)

  • Heart Rate

    Prior to each acupuncture session (experimental group only)

  • Defense and Veterans Pain Rating Scale (DVPRS)

    Prior to each acupuncture session and at the end of each acupuncture session (experimental group only)

Study Arms (2)

Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL
Procedure: Manual Standardized Stress Acupuncture (MSSA)Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Mindfulness-Based Stress Reduction (MBSR)

ACTIVE COMPARATOR
Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Interventions

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.

Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR)Mindfulness-Based Stress Reduction (MBSR)

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.

Manual Standardized Stress Acupuncture (MSSA) and Mindfulness-Based Stress Reduction (MBSR)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active duty and veteran service members,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center, San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 21, 2023

Study Start

September 1, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

January 28, 2026

Record last verified: 2025-05

Locations