A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Structured Breathing
Behavioral15, 30, or 36 minute structured breathing sessions based on personal skill level.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Breathing InterventionExperimental treatment 1 intervention
Trial outcomes
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 months3
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 months4
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 monthsSecondary 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 period3
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 completeSponsors and contacts
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Source ClinicalTrials.gov