Structured Breathing
Behavioral15, 30, or 36 minute structured breathing sessions based on personal skill level.
NCT Number: NCT07218458
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Mayo Clinic Health System-Albert Lea, Albert Lea, Minnesota, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
15, 30, or 36 minute structured breathing sessions based on personal skill level.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Danielle Boos
CONTACT
Paul Min, PhD
CONTACT
Mayo Clinic
Other
Enhancing Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals (Breathing Study-Burnout)
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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