Acupuncture for Perceived Stress in Military Personnel: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Descriptive statistics and Qualitative Text Summary
研究概览
简要总结
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.
详细描述
SPECIFIC OBJECTIVES:
Aim 1a: To determine feasibility of recruitment in service members for SSA. Expected Outcome: Participants will agree to receive SSA treatment for their perceived stress.
Aim 1b: To determine feasibility of implementation of study procedures including the following (Lancaster et al., 2004):
- Inclusion and exclusion criteria.
- Consent form procedures.
- Storage and testing of equipment and materials (i.e., use of acupuncture needles, videotaping procedures, peer review feedback, randomization of peer review sessions, and use of a secure system for data management).
- Training of staff in the administration of questionnaires and informed consent process.
- Testing out the administration of data collection forms and questionnaires. Expected Outcome: The primary investigator (PI) will record field notes and report lessons learned in preparation for a trial with methodological rigor.
Aim 2: To determine the acceptability of SSA treatment in a sample of military personnel with perceived stress using the Acupuncture Expectancy Scale (AES) (Mao, Xie, & Bowman, 2010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Descriptive statistics and Qualitative Text Summary
时间窗: Throughout the study (4 weeks)
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.
次要结局
- Perceived Stress Scale (PSS)(Baseline and posttreatment measure at week 4.)
- Short Form-36 Health Survey(Baseline and posttreatment measure at week 4.)
- Acupuncture Expectancy Scale (AES)(Baseline and posttreatment measure at week 4.)
研究者
Jane J. Abanes
Principal Investigator
United States Naval Medical Center, San Diego