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临床试验/NCT04625777
NCT04625777已完成不适用

Acceptability, Feasibility, and Outcomes Testing to Reduce Stress Symptoms Among Clergy

Duke University2 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
390
试验地点
2
主要终点
Change in self-reported stress symptoms

研究概览

简要总结

Certain populations may be particularly susceptible to the adverse effects of chronic stress, particularly chronic work-related stress. One such population is that of clergy doing ministry work. Clergy who are interested in stress reduction will choose one of three interventions: Mindfulness Based Stress Reduction, the Daily Examen, or a set of stress inoculation and breathing exercises called Stress Proofing. The study investigators will examine changes in heart rate variability and self-reported stress symptoms over time among clergy who have participated in one of the three interventions, compared to clergy who have not yet received one of the interventions. The aim of this study is to determine trends in stress outcomes for each of the three interventions. The investigators hypothesize that participation in each intervention will be associated with an improvement in stress outcomes compared to those who have not yet received an intervention.

详细描述

Certain populations may be particularly susceptible to the adverse effects of chronic stress, particularly chronic work-related stress. One such population is that of clergy doing ministry work. Clergy exhibit high prevalence rates of chronic disease, including diabetes, hypertension, asthma, and joint-related disease, as well as obesity. Further, studies also indicate above-average rates of depression. While no studies directly compare rates of clinical anxiety among clergy versus non-clergy, anxiety rates among clergy are elevated. The high prevalence of physical and mental health issues among clergy may be due in part to stressors from the unique nature of clergy work.

A prominent theory of stress is the job-demand-control-support (JDCS) model, which indicates that stressful jobs are those characterized by high demand, low control, and low support. Clergy perform many demanding roles, including inspiring the congregation, providing one-on-one care for congregants, performing sacraments, educating congregants, overseeing educational programming, and leading social justice activities. The work week typically averages 50 hours or more with the expectation of being on call around-the-clock and the range of skills needed is broad. While certain tasks such as preaching are predictable, clergy have no control over the timing of funerals and congregant crises, and only a variable degree of control over congregant perception of the direction the clergy are taking the congregation. Congregants who are committed to the congregation have strong and often conflicting opinions. In terms of support, clergy experience work-related support to varying degrees; they direct essentially a volunteer workforce and, with the wide range of tasks conducted, they often do not receive the support needed to match the tasks or the emotional challenges faced.

Researchers have developed numerous approaches to manage stress, such as cognitive-behavioral therapy, mindfulness, and relaxation. Not all stress-management interventions are equally effective. Rather, stress-reducing activities are viewed as skills that require regular practice. As such, the most effective interventions are those that individuals are willing and motivated to practice (i.e., patient-preference is an important aspect of evidence-based practice). The current study builds on a pilot study that the investigators conducted with clergy to evaluate the feasibility and acceptability of four potentially stress-reducing interventions while taking participant preference into account. Three of those stress-reducing interventions showed trends of self-reported stress reduction in terms of reduced stress symptoms and/or reactivity to stress. In the current study, the investigators test those three interventions: Mindfulness Based Stress Reduction, the Daily Examen, and a set of stress inoculation and breathing exercises called Stress Proofing.

The study design is a waitlist preferences design. As such, participants choose which of the three interventions they prefer, taking into account the intervention content, format, and scheduling dates. The intervention groups will consist of clergy who sign up for the intervention during the initial recruitment phase and are randomly assigned to start before November 2020. (A secondary per-protocol analysis will include in the intervention groups any clergy who sign up for the intervention after the initial recruitment phase.) The control group will consist of clergy who sign up for the intervention during the initial recruitment phase and are randomly assigned to an intervention start time of November 2020 or later. In addition to random assignment to immediate-start versus delayed-start (waitlist), participants who indicate equal preference for two or more interventions will be randomly assigned to one of their preferred interventions. The investigators' study design allows for testing stress outcomes between those participants who preferred that intervention and those who were waiting for intervention. The design will not allow for comparing outcomes between interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

The analysis statistician will remain blinded to intervention allocation and waitlist randomized assignment until the analysis plan has been finalized and initial blind reviews have been performed.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a current appointment in July 2019 of the North Carolina (NC) Annual Conference or the Western NC Annual Conference of the United Methodist Church (UMC).

排除标准

  • 未提供

结局指标

主要结局

Change in self-reported stress symptoms

时间窗: 12 weeks

We are using a modified version of the Calgary Symptoms of Stress Inventory and will use continuous mean scores of the overall measure (i.e., all subscales combined). The minimum will be 0 and the maximum 4, with higher scores indicating higher symptoms.

Change in Heart Rate Variability

时间窗: 12 weeks

We will collect 48-hour ambulatory heart rate variability (HRV) data using EKG devices.

次要结局

  • Change in anxiety symptoms(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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