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NCT Number: NCT07218458

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System-Albert Lea, Albert Lea, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Structured Breathing

Behavioral

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

Primary outcomes

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

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

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

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

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

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

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

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

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

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

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

    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.

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

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

    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.

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

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

    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.

  7. Assess participant satisfaction related to breathing-based intervention

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

    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).

Secondary outcomes

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

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

    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.

Other outcomes

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

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

    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.

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

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

    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).

  3. Assess feasibility of collecting physiological and psychological data

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

    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.

  4. Assess gathered data to apply to future research

    Time frame: Data analysis period after data collection is complete

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Boos

CONTACT

[email protected]

715-464-8173

Paul Min, PhD

CONTACT

[email protected]

507-255-2814

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Enhancing Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals (Breathing Study-Burnout)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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