Clinical trial NCT06044714: Effects of Acupuncture on Perceived Stress and Health in Military Service Members
Official title: Effects of Acupuncture on Perceived Stress and Health in Military Service Members and Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perceived Stress
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: TriService Nursing Research Program
name: University of California, San Francisco
First posted: 2023-09-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: At baseline, at two weeks post interventions, and at four weeks post interventions
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: At baseline, at two weeks post interventions, and at four weeks post interventions
measure: The Short Form (SF) Health Survey
timeFrame: At baseline, at two weeks post interventions, and at four weeks post interventions
measure: Journal Log
timeFrame: At weeks 2 and 4 after treatments have been completed.
Other outcomes:
measure: Blood Pressure (systolic and diastolic)
timeFrame: Prior to each acupuncture session (experimental group only)
measure: Heart Rate
timeFrame: Prior to each acupuncture session (experimental group only)
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Prior to each acupuncture session and at the end of each acupuncture session (experimental group only)
Locations:
city: San Diego
country: United States
facility: Naval Medical Center, San Diego
state: California
Study officials:
References: