NCT07218458

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

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 Progress48%
Oct 2025Nov 2026

First Submitted

Initial submission to the registry

October 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

October 27, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

October 15, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

burnoutbreathing

Outcome Measures

Primary Outcomes (7)

  • 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.

    Enrollment to end of study participation at 4 months.

  • 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.

    Enrollment to end of study participation at 4 months

  • 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.

    Enrollment to end of study participation at 4 months

  • 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.

    Enrollment to end of study participation at 4 months

  • 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.

    Enrollment to end of study participation at 4 months

  • 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.

    From enrollment to the end of study participation at 4 months

  • 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).

    Enrollment to end of study participation at 4 months.

Secondary Outcomes (1)

  • Evaluate intervention adherence, usability, and engagement metrics via mobile application

    Enrollment to end of treatment at 4 months.

Other Outcomes (4)

  • Assess the physiological effects of the breathing-based intervention

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

  • Assess the psychological effects of the breathing-based intervention

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

  • Assess feasibility of collecting physiological and psychological data

    Enrollment to end of study participation at 4 months.

  • +1 more other outcomes

Study Arms (1)

Breathing Intervention

EXPERIMENTAL

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

Behavioral: Structured Breathing

Interventions

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

Breathing Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Burnout, PsychologicalRespiratory Aspiration

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pravesh Sharma, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2025

First Posted

October 20, 2025

Study Start

October 27, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations