Study Protocol for a Single-Arm Pilot Feasibility Trial Evaluating a Structured Breathing-Based Intervention to Reduce Burnout and Enhance Mental Well-Being Among Healthcare Professionals in Community-Based Practice Settings

IntroductionBurnout among healthcare professionals remains a critical public health issue linked to impaired cognition, emotional exhaustion, and diminished clinical performance. Structured breathing practices have demonstrated promise in improving autonomic regulation and cerebral oxygenation, yet their feasibility and acceptability in real-world healthcare settings remain underexplored. ObjectivesThis single-arm pilot feasibility trial aims to evaluate the feasibility, acceptability, and implementation appropriateness of a structured breathing-based intervention for healthcare professionals across community-based Mayo Clinic Health System (MCHS) sites. Secondary objectives include assessing usability and engagement with the mobile breathing platform, while exploratory analyses will examine preliminary signals of change in psychological well-being and cerebral hemodynamics. Methods and AnalysisA total of 40 physicians and nurses reporting moderate or greater burnout will be enrolled across four MCHS sites. Participants will complete a four-month structured breathing program delivered primarily online, supported by a mobile application for practice tracking. Assessments will occur at baseline, 2 months, and 4 months, with optional functional near-infrared spectroscopy (fNIRS) measures of cerebral oxygenation collected at baseline and 4 months in a subset. Primary outcomes include (1) recruitment yield, retention, and adherence rates; (2) acceptability and participant satisfaction (survey and qualitative feedback); and (3) implementation appropriateness measured by the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Secondary outcomes assess digital engagement and usability through mobile analytics and the System Usability Scale (SUS). Exploratory outcomes evaluate psychological indicators--burnout, depression, anxiety, perceived stress, sleep, fatigue, professional fulfillment, and resilience--and physiological endpoints (fNIRS). Analyses will be descriptive, summarizing feasibility metrics with 95% confidence intervals. Progression criteria (recruitment [≥]75%, retention [≥]80%, adherence [≥]70%, AIM/IAM/FIM [≥]4.0) will determine readiness for a definitive hybrid effectiveness-implementation trial. Ethics and DisseminationThe study is approved by the Mayo Clinic Institutional Review Board (IRB # 25-009320). All participants will provide informed consent. Study procedures ensure confidentiality, cultural sensitivity, and participant safety. Data will be securely stored in REDCap and disseminated through peer-reviewed publications and scientific conference ClinicalTrials.gov IDThe study has been prospectively registered at ClinicalTrials.gov (Identifier NCT07218458). Strengths and LimitationsO_LIEvaluates a structured breathing-based intervention using both subjective and objective indicators of feasibility, including recruitment, retention, adherence, and implementation appropriateness. C_LIO_LIIntegrates mobile application analytics with standardized implementation measures (AIM, IAM, FIM) to capture digital engagement and real-world usability. C_LIO_LIIncorporates functional near-infrared spectroscopy (fNIRS) to explore physiological mechanisms underlying burnout recovery, linking cerebral oxygenation to behavioral outcomes. C_LIO_LIConducted across diverse community-based Mayo Clinic Health System sites, enhancing ecological validity and relevance to decentralized clinical settings. C_LIO_LILimitations include the single-arm, region-restricted design, modest sample size, and reliance on volunteer participants, which constrain generalizability and preclude causal inference; exploratory outcomes are intended to guide future trial refinement. C_LI