Acupuncture for Perceived Stress in Military Personnel

NCT03364361 | Completed

• 1 other identifier: NHCP. 2017.0057
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Although the physiologic response to stress is necessary for mammals to survive, prolonged stress response as a result of perceived stress can lead to allostatic load and loss of resilience to future stressors. To mitigate the consequences of allostatic load, researchers have investigated the effects of acupuncture as a promising intervention. Objectives/Aims: The purpose of this study is to explore the feasibility and effect of a standardized stress acupuncture (SSA) approach on perceived stress in U.S. military personnel. Specific aims include the following: a) to determine feasibility of recruitment for SSA and implementation of study procedures in preparation for a methodologically rigorous study, b) to determine the acceptability of SSA treatment in a sample of military personnel with perceived stress, and c) to assess perceived stress and general health before and after SSA. Methods and Analysis: This is a single-arm, single-site study protocol to assess feasibility of SSA in a total of 15 patients with perceived stress. Upon IRB approval and written informed consent, the participants will receive 4 weekly sessions of SSA which consists of 6 acupuncture points. Demographic information and attrition of participants will be monitored throughout the study. Patient-reported questionnaires including Acupuncture Expectancy Scale, Perceived Stress Scale, and SF-36 will be administered at baseline and then at the completion of the study. Descriptive statistics, reliable change indices (RCI), and Wilcoxon Signed-Ranks tests will be conducted to assess the magnitude of changes in scores. Military Relevance: The three most common disability conditions in the military include musculoskeletal, psychiatric, and neurological body systems. Among these problems, however, mental health disorders remain a significant contributor to disability and suicide. Given the role of perceived stress in disability and suicidality in the military, intervening early before service members become at risk for severe injuries, hospitalizations, and chronic disability could help decrease burdensome problems.

Conditions

Acupuncture; Perceived Stress; Military Personnel

Outcome Measures

Primary Outcomes (1)

• Descriptive statistics and Qualitative Text Summary

  Descriptive statistics will be used to describe the following: a) the sample, b) critical demographic, and service information of the participants, c) the number of individuals screened for the study versus the number of participants, and d) the number of participants who completed all visits versus the number of participants who withdrew from the study. The analysis of this aim will be qualitative in nature. At the end of the study, a text summary of feasibility of study procedures will be provided to delineate field notes and lessons learned in the implementation of this study.

  Throughout the study (4 weeks)

Secondary Outcomes (3)

• Acupuncture Expectancy Scale (AES)

  Baseline and posttreatment measure at week 4.

• Perceived Stress Scale (PSS)

  Baseline and posttreatment measure at week 4.

• Short Form-36 Health Survey

  Baseline and posttreatment measure at week 4.

Study Arms (1)

Acupuncture

OTHER

Feasibility Study

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Participants will receive a six-point standardized stress acupuncture (SSA) treatment once a week for 4 weeks. The SSA consists of GV- 20, GV-24.5 (Yin Tang), bilateral LI-4, and bilateral LR-3. This acupuncture protocol has been used as an effective treatment for stress-related symptoms in the operational theater.

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty service members will be considered eligible upon meeting the following criteria: 18 to 65 years of age, Self-report of perceived stress for at least one month. A score of 16 or above on the PSS. The choice of 16 on the PSS scale, as an eligibility criterion, was based on previous studies that use the same score criterion to describe the impact of perceived stress on allostatic load and the effect of acupuncture for perceived stress (Groer et al., 2016; Schroeder et al., 2017). Stable on psychiatric and other medications for at least three months. Able to sign an informed consent.

You may not qualify if:

• Recent medical surgery within one month; Alcohol abuse or dependence diagnosis within one month and active substance use/abuse/dependency treatment within one month; Pregnant women. Acupuncture can result in an induction of labor and spontaneous abortion in rare occasions(White et al., 2008); Has had acupuncture treatment in the past month.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Vanderbilt University: collaborator

Study Sites (1)

Naval Medical Center

San Diego, California, 92134, United States

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: February 12, 2018
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)