Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04625777 |
| Other study ID # |
2019-0238 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2020 |
| Est. completion date |
October 7, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
