The Selah trial: A preference-based partially randomized waitlist control study of three stress management interventions

Objective Chronic stress can undermine psychological and physiological health. We sought to evaluate three stress management interventions among clergy, accounting for intervention preferences. Methods United Methodist clergy in North Carolina enrolled in a partially randomized, preference-based waitlist control trial. The interventions were: mindfulness-based stress reduction (MBSR), Daily Examen prayer practice, and Stress Proofing (stress inoculation plus breathing skills). The intervention period spanned 12 weeks with a 12-week follow-up. Daily text message data were collected to assess practice across the 24 weeks. Co-primary outcomes were symptoms of stress using the Calgary Symptoms of Stress Inventory and 48-hour ambulatory heart rate variability (HRV) at 12-weeks post-intervention compared to waitlist control. Survey data were collected at 0, 12 and 24 weeks, with HRV collected at 0 and 12 weeks. Results 255 participants (mean age=54 years old; 91% white; 48% female) were randomized and initiated an intervention (n=184) or waitlist control (n=71). Compared to waitlist control, lower stress symptoms were found for MBSR participants [Mean Difference (MD)=-0.30, 95% CI:-0.41,-0.20; p <.001] and Stress Proofing (MD=-0.27, 95% CI:-0.40,-0.14; p <.001) at 12 weeks, and Daily Examen participants not until 24 weeks (MD=-0.24, 95% CI:-0.41,-0.08). Only MBSR participants demonstrated improvement in HRV at 12 weeks (MD=+3.32 millisecond; 95% CI:0.21,6.44; p =.036). Conclusions MBSR demonstrated robust improvement in self-reported and objective physical correlates of stress whereas Stress Proofing and Daily Examen resulted in improvements in self-reported correlates of stress only. These brief practices were sustainable and beneficial for an occupational sample during the COVID pandemic. Registration [ClinicalTrials.gov][1] identifier: [NCT04625777][2] () ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04625777 ### Funding Statement This study was funded by the Rural Church Area of The Duke Endowment. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The IRB of Duke University gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The datasets generated during the current study are not publicly available but we will make de-identified data available for reasonable requests compliant with ethical approvals from the sending and receiving hosts institutional ethics review boards. * (HRV) : Mindfulness-Based Stress Reduction (MBSR) Heart rate variability (UMC) : United Methodist Church (C-SOSI) : Calgary-Symptoms of Stress Inventory (MESOR) : Midline Estimating Statistic Of Rhythm (GAD-7) : Generalized Anxiety Disorder-7 (PHQ-8) : Patient Health Questionnaire-8 (ICC) : Interclass correlation coefficient (cLDA) : Constrained longitudinal data analysis modeling (MICE) : Multiple imputation with chained equations (ms) : Milliseconds (MD) : Mean difference (BMI) : Body Mass Index (RCTs) : Randomized controlled trials [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04625777&atom=%2Fmedrxiv%2Fearly%2F2023%2F01%2F28%2F2023.01.24.23284965.atom