Occupational StressNCT04625777
Selah Trial of Stress Interventions for Clergy: Mindfulness Based Stress Reduction, Daily Examen, and Stress Inoculation
A study testing Mindfulness Based Stress Reduction, Daily Examen spiritual practice and Stress inoculation combination in people with Occupational Stress, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress
- What is being tested?
- Mindfulness Based Stress Reduction, Daily Examen spiritual practice and Stress inoculation combination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 7 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability, Feasibility, and Outcomes Testing to Reduce Stress Symptoms Among Clergy
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.
Read the detailed 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.
- Conditions
- Occupational Stress
- Being tested
- Mindfulness Based Stress Reduction, Daily Examen spiritual practice, Stress inoculation combination
- Keywords
- Life Stress, Job Stress, Work-related Stress, Mindfulness, Spiritual
- Medical subject headings
- Occupational Stress, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Mindfulness Based Stress Reduction (MBSR) teaches several different kinds of meditation. MBSR is offered as an online course through Duke Integrative Medicine and is based on the national model first developed by Jon Kabat-Zinn at the University of Massachusetts. It includes exercises in awareness of breath, body scans, walking meditation, "choiceless" open awareness, Loving Kindness Meditation, and bringing awareness to the present moment. The MBSR Distance Learning course consists of 8 weekly sessions via video conference and includes meditation instruction, periods of guided practice, and group discussion.
Daily Examen spiritual practiceBehavioural
The Daily Examen is a simple but powerful prayer used by Jesuits every day. It takes only 10-15 minutes and can be used to reflect on positive emotions, move past negative emotions, and align one's work with God's work. The Examen directs the person praying to focus on a five-step routine:
- Become aware of God's presence;
- Give thanks to God for everything in your life;
- Review the events of the day guided by the Holy Spirit;
- Look at what went well or wrong in the past day; if at fault, ask God for forgiveness; and
- Look toward tomorrow - what one thing should you do? Listen to what God is telling you.
Stress inoculation combinationBehavioural
This intervention includes a combination of stress inoculation and general stress reduction activities focused on physiology, with exercises that bypass the brain and work directly on the body to mitigate the symptoms of stress. This system is based on Stress Inoculation Training, which uses breathing to prepare people in advance for stressful episodes and recovery skills for following such episodes. The techniques include a variety of breathing, blood flow, and tension control methods, as well as ways to conduct deep tissue massage on oneself to release muscle tension. The awareness aspect involves understanding stress biology and learning to spot the symptoms of stress in oneself and others.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control | No intervention | In this waitlist control condition, participants will not receive any programming intervention. They will know that they have access to stress reduction programming after a certain date. They will also provide survey data at 3 time points and heart rate variability data at 2 time points while waiting. The survey questions will include a wide variety of stress items. |
| One of three stress reduction interventions | Experimental | There are three stress reduction interventions: Mindfulness Based Stress Reduction, Daily Examen, and stress inoculation. Receives: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Daily Examen spiritual practice; Behavioral: Stress inoculation combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported stress symptoms
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.
Measured: 12 weeks
Change in Heart Rate Variability
We will collect 48-hour ambulatory heart rate variability (HRV) data using EKG devices.
Measured: 12 weeks
Secondary outcomes (1)
Change in anxiety symptoms
We will use continuous scores (min=0, max=21; higher scores=higher anxiety symptoms) of the Generalized Anxiety Disorder-7 measure.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start6 Jan 2020
- Primary completion5 Aug 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will employ a waitlist preference trial study design. Participants will rank the three interventions and be assigned to their highest-ranking intervention. Participants who rank three interventions equally will be randomly assigned to one of the interventions or the waitlist group. Participants who rank two interventions equally will be randomly assigned to one of their preferred interventions and then randomly assigned to immediate intervention vs waitlist. For the waitlist, participants will be randomly assigned to an intervention with an immediate start of prior to Nov 2020, or to the waitlist control group with a delayed start of Nov 2020 or later. If assigned to the delayed start (a.k.a. waitlist) group, they will be asked for data while waiting (i.e. control group data). The investigators may continue to enroll additional participants following the initial enrollment period and receive their preferred intervention without randomization.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rae Jean Proeschold-Bell, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625777
- Sponsor's protocol ID
- 2019-0238
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Proeschold-Bell RJ, Eagle DE, Tice LC, Platt A, Yao J, Larkins JS, Kim ET, Rash JA. The Selah trial: A preference-based partially randomized waitlist control study of three stress management interventions. Transl Behav Med. 2025 Jan 16;15(1):ibae017. doi: 10.1093/tbm/ibae017.
PubMed 38718169Proeschold-Bell RJ, Eagle DE, Tice LC, Yao J, Rash JA, Choi JY, Stringfield B, Labrecque SM. The Selah Pilot Study of Spiritual, Mindfulness, and Stress Inoculation Practices on Stress-Related Outcomes Among United Methodist Clergy in the United States. J Relig Health. 2023 Aug;62(4):2686-2710. doi: 10.1007/s10943-023-01848-x. Epub 2023 Jun 26.
PubMed 37365439Tice LC, Eagle DE, Rash JA, Larkins JS, Labrecque SM, Platt A, Yao J, Proeschold-Bell RJ. The Selah study protocol of three interventions to manage stress among clergy: a preference-based randomized waitlist control trial. Trials. 2021 Dec 9;22(1):892. doi: 10.1186/s13063-021-05845-x.
PubMed 34886896
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility, and Outcomes Testing to Reduce Stress Symptoms Among Clergy
- ClinicalTrials.gov ID
- NCT04625777
- Acronym / sponsor ID
- 2019-0238
- Conditions
- Occupational Stress
- Keywords
- Life Stress, Job Stress, Work-related Stress, Mindfulness, Spiritual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The investigators will employ a waitlist preference trial study design. Participants will rank the three interventions and be assigned to their highest-ranking intervention. Participants who rank three interventions equally will be randomly assigned to one of the interventions or the waitlist group. Participants who rank two interventions equally will be randomly assigned to one of their preferred interventions and then randomly assigned to immediate intervention vs waitlist. For the waitlist, participants will be randomly assigned to an intervention with an immediate start of prior to Nov 2020, or to the waitlist control group with a delayed start of Nov 2020 or later. If assigned to the delayed start (a.k.a. waitlist) group, they will be asked for data while waiting (i.e. control group data). The investigators may continue to enroll additional participants following the initial enrollment period and receive their preferred intervention without randomization.
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | No intervention | –In this waitlist control condition, participants will not receive any programming intervention. They will know that they have access to stress reduction programming after a certain date. They will also provide survey data at 3 time points and heart rate variability data at 2 time points while waiting. The survey questions will include a wide variety of stress items. |
| One of three stress reduction interventions | Experimental | Behavioral: Mindfulness Based Stress Reduction, Behavioral: Daily Examen spiritual practice, Behavioral: Stress inoculation combinationThere are three stress reduction interventions: Mindfulness Based Stress Reduction, Daily Examen, and stress inoculation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionMindfulness Based Stress Reduction (MBSR) teaches several different kinds of meditation. MBSR is offered as an online course through Duke Integrative Medicine and is based on the national model first developed by Jon Kabat-Zinn at the University of Massachusetts. It includes exercises in awareness of breath, body scans, walking meditation, "choiceless" open awareness, Loving Kindness Meditation, and bringing awareness to the present moment. The MBSR Distance Learning course consists of 8 weekly sessions via video conference and includes meditation instruction, periods of guided practice, and group discussion. | Behavioural | One of three stress reduction interventions |
| Daily Examen spiritual practiceThe Daily Examen is a simple but powerful prayer used by Jesuits every day. It takes only 10-15 minutes and can be used to reflect on positive emotions, move past negative emotions, and align one's work with God's work. The Examen directs the person praying to focus on a five-step routine: 1. Become aware of God's presence; 2. Give thanks to God for everything in your life; 3. Review the events of the day guided by the Holy Spirit; 4. Look at what went well or wrong in the past day; if at fault, ask God for forgiveness; and 5. Look toward tomorrow - what one thing should you do? Listen to what God is telling you. | Behavioural | One of three stress reduction interventions |
| Stress inoculation combinationThis intervention includes a combination of stress inoculation and general stress reduction activities focused on physiology, with exercises that bypass the brain and work directly on the body to mitigate the symptoms of stress. This system is based on Stress Inoculation Training, which uses breathing to prepare people in advance for stressful episodes and recovery skills for following such episodes. The techniques include a variety of breathing, blood flow, and tension control methods, as well as ways to conduct deep tissue massage on oneself to release muscle tension. The awareness aspect involves understanding stress biology and learning to spot the symptoms of stress in oneself and others. | Behavioural | One of three stress reduction interventions |
Primary outcome
Change in self-reported stress symptoms
Time frame: 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
Time frame: 12 weeks
We will collect 48-hour ambulatory heart rate variability (HRV) data using EKG devices.
1 secondary outcome
Change in anxiety symptoms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 38718169Proeschold-Bell RJ, Eagle DE, Tice LC, Platt A, Yao J, Larkins JS, Kim ET, Rash JA. The Selah trial: A preference-based partially randomized waitlist control study of three stress management interventions. Transl Behav Med. 2025 Jan 16;15(1):ibae017. doi: 10.1093/tbm/ibae017.
- Derived from this study: PubMed 37365439Proeschold-Bell RJ, Eagle DE, Tice LC, Yao J, Rash JA, Choi JY, Stringfield B, Labrecque SM. The Selah Pilot Study of Spiritual, Mindfulness, and Stress Inoculation Practices on Stress-Related Outcomes Among United Methodist Clergy in the United States. J Relig Health. 2023 Aug;62(4):2686-2710. doi: 10.1007/s10943-023-01848-x. Epub 2023 Jun 26.
- Derived from this study: PubMed 34886896Tice LC, Eagle DE, Rash JA, Larkins JS, Labrecque SM, Platt A, Yao J, Proeschold-Bell RJ. The Selah study protocol of three interventions to manage stress among clergy: a preference-based randomized waitlist control trial. Trials. 2021 Dec 9;22(1):892. doi: 10.1186/s13063-021-05845-x.
- Study description and recruitment websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rae Jean Proeschold-Bell, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction, Daily Examen spiritual practice and Stress inoculation combination in people with Occupational Stress, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported stress symptoms (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625777, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.