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RecruitingNCT07218458Updated May 5, 2026

A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals

An interventional study of Structured Breathing in Burnout, Healthcare Workers and Breathing Exercises, sponsored by Mayo Clinic. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to assess the immediate and long-term effects of structured breathing on clinical symptoms related to mental health including anxiety, depression, perceived stress, and sleep quality.

02

Conditions studied

  • Burnout, Healthcare Workers
  • Breathing Exercises

Keywords

  • burnout
  • breathing
03

In context

Burnout, Psychological

442 studies on the registry are indexed under Burnout, Psychological; 106 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 319 interventional studies indexed under Burnout, Psychological.

Browse Burnout, Psychological studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants must be healthcare professionals at the above-mentioned 4 MCHS sites (Eau Claire, La Crosse, Mankato, Albert Lea).
  • Must score ≥40 on Copenhagen Burnout Inventory Q1-6.
  • Participants must be physically fit enough to perform light exercise.
  • Participants should read and understand English well enough to consent, complete measures, and follow instructions.
  • Participants must have access to a smartphone or tablet.

Exclusion criteria

Exclusion Criteria:

  • Active primary psychotic disorder or substance use disorder (except nicotine dependence) within the past year.
  • Severe or unstable medical condition that could interfere with participation or data collection.
  • Active neurological condition (including seizure disorder, traumatic brain injury, or stroke) that could affect cognitive functioning or brain imaging results.
  • Chronic lung disease (e.g., COPD, cystic fibrosis) or aneurysm.
  • Current pregnancy or planning to become pregnant during the study period
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Breathing Intervention

    Engaging in self-guided breathing sessions to improve brain circulation and mental well-being.

    Behavioral: Structured Breathing

Interventions

  • BehavioralStructured Breathing

    15, 30, or 36 minute structured breathing sessions based on personal skill level.

06

What researchers measure

Primary outcomes

  1. Assess feasibility of the structured breathing-based intervention among healthcare professionals via ease of recruitment

    This outcome measure will assess whether the structured breathing-based intervention is feasible among healthcare professionals via ease of recruitment reported by study staff.

    Time frame: Enrollment to end of study participation at 4 months.

  2. Assess feasibility of the structured breathing-based intervention among healthcare professionals via retention statistics

    This outcome measure will assess the feasibility of the structured breathing-based intervention among healthcare professionals by examining retention rates throughout study duration.

    Time frame: Enrollment to end of study participation at 4 months

  3. Assess feasibility of the structured breathing-based intervention among healthcare professionals via mobile app engagement metrics

    This outcome measure will assess whether the structured breathing-based intervention is feasible among healthcare professionals by analyzing app usage metrics from participants.

    Time frame: Enrollment to end of study participation at 4 months

  4. Assess feasibility of structured breathing-based intervention among healthcare professionals via Feasibility of Intervention Measure

    To assess the feasibility of a structured breathing intervention among healthcare professionals using Feasibility of Intervention Measure (FIM). Feasibility of Intervention Measure is a four-item measure of implementation feasibility with scores ranging from 1-5, with higher scores indicating greater feasibility.

    Time frame: Enrollment to end of study participation at 4 months

  5. Assess appropriateness of structured breathing-based intervention among healthcare professionals

    To assess the appropriateness of a structured breathing intervention among healthcare professionals using Intervention Appropriateness Measure (IAM). Intervention Appropriateness Measure is a four-item measure with a scale of responses from 1-5, with higher scores indicating greater appropriateness.

    Time frame: Enrollment to end of study participation at 4 months

  6. Assess acceptability of structured breathing-based intervention among healthcare professionals

    To assess the acceptability of a structured breathing intervention among healthcare professionals utilizing the Acceptability of Intervention Measure (AIM). Acceptability of Intervention Measure is a four-item measure with responses from 1-5, with higher scores equating to greater acceptability.

    Time frame: From enrollment to the end of study participation at 4 months

  7. Assess participant satisfaction related to breathing-based intervention

    Participant satisfaction will be assessed through a mixed-methods approach combining quantitative surveys (exit survey) and qualitative participant interviews (4 month in-person visit/interview).

    Time frame: Enrollment to end of study participation at 4 months.

Secondary outcomes

  1. Evaluate intervention adherence, usability, and engagement metrics via mobile application

    To evaluate the breathing intervention adherence, usability, and engagement metrics collected through the mobile application platform. These data will be used to identify barriers and facilitators to digital engagement, assess usability, and inform refinements to the intervention's delivery and technological infrastructure for future large-scale trials.

    Time frame: Enrollment to end of treatment at 4 months.

Other outcomes

  1. Assess the physiological effects of the breathing-based intervention

    As an exploratory objective, the study will assess the physiological effects of the breathing-based intervention on cerebral oxygenation and local tissue hemodynamics, utilizing functional near-infrared spectroscopy (fNIRS) data performed pre-and-post intervention.

    Time frame: Enrollment to end of intervention at 4 months. Additional assessments during data analysis period.

  2. Assess the psychological effects of the breathing-based intervention

    The psychological effects and outcomes will be assessed, using questionnaires completed at specific timepoints throughout the study. Questionnaires to include General Health Questionnaire (GHQ), Copenhagen Burnout Inventory (CBI), Generalized Anxiety Disorder scale (GAD), Perceived Stress Scale (PSS), Brief Resilience Scale (BRS).

    Time frame: Enrollment to end of intervention at 4 months. Additional assessments during data analysis period

  3. Assess feasibility of collecting physiological and psychological data

    This exploratory analysis is intended to assess the feasibility of collecting physiological and psychological data from participants, as reported by study staff who are assigned to collect this data.

    Time frame: Enrollment to end of study participation at 4 months.

  4. Assess gathered data to apply to future research

    This exploratory analysis will examine study data to identify preliminary trends that can inform the design and power calculations of future definitive trials.

    Time frame: Data analysis period after data collection is complete

07

Study locations

1 of 4 sites recruiting
  • Mayo Clinic Health System-Albert Lea
    Albert Lea, Minnesota 56007, United States
    Active, not recruiting
  • Mayo Clinic Health System-Mankato
    Mankato, Minnesota 56001, United States
    Active, not recruiting
  • Mayo Clinic Health System-Eau Claire Clinic
    Eau Claire, Wisconsin 54703, United States
    Recruiting
  • Mayo Clinic Health System-La Crosse
    La Crosse, Wisconsin 54601, United States
    Active, not recruiting
08

References and documents

Publications

  • Sharma P, Osman R, Nycklemoe M, Boos DM, Murphy CM, Flock C, Jacobson DN, Lim S, Nation JL, Wilson MA, Schuldt K, Min PH. Evaluation of a structured breathing-based intervention to reduce burnout and enhance mental well-being among healthcare professionals in community-based practice settings: study protocol for a single-arm pilot feasibility trial. BMJ Open. 2026 Feb 27;16(2):e113105. doi: 10.1136/bmjopen-2025-113105. PubMed 41760153 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07218458
Lead sponsor
Mayo Clinic
Responsible party
Pravesh Sharma (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 20, 2025
Start date
Oct 27, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
May 5, 2026

Study contacts

Danielle Boos
Contact
boos.danielle@mayo.edu
715-464-8173
Paul Min, PhD
Contact
min.paul@mayo.edu
507-255-2814
Pravesh Sharma, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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