NCT04625777

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

November 6, 2020

Last Update Submit

March 8, 2022

Conditions

Occupational Stress

Keywords

Life StressJob StressWork-related StressMindfulnessSpiritual

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • Change in Heart Rate Variability

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

    12 weeks

Secondary Outcomes (1)

  • Change in anxiety symptoms

    12 weeks

Other Outcomes (2)

  • Change in perceived stress symptoms

    24 weeks

  • Change in anxiety symptoms

    24 weeks

Study Arms (2)

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.

Behavioral: Mindfulness Based Stress ReductionBehavioral: Daily Examen spiritual practiceBehavioral: Stress inoculation combination

Interventions

Mindfulness Based Stress ReductionBEHAVIORAL

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.

One of three stress reduction interventions
Daily Examen spiritual practiceBEHAVIORAL

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: 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.

One of three stress reduction interventions
Stress inoculation combinationBEHAVIORAL

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.

One of three stress reduction interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (3)

  • 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.

    PMID: 38718169DERIVED

  • Proeschold-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.

    PMID: 37365439DERIVED

  • Tice 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.

    PMID: 34886896DERIVED

Related Links

MeSH Terms

Conditions

Occupational StressStress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Occupational DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rae Jean Proeschold-Bell, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

January 6, 2020

Primary Completion

August 5, 2021

Study Completion

October 7, 2021

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)