Enhancing Brain And Mental Health Through Breathing Practice

Enhancing Brain And Mental Health Through Breathing Practice: Clinical Applications In Rural Adolescents With Psychiatric Symptoms (Breathing Study -Adolescent)

The purpose of this study is to evaluate the feasibility of a structured breathing intervention in rural and non-rural adolescents diagnosed with anxiety and depression, recruited from outpatient pediatric and child/adolescent psychiatry clinics.

Study Overview

• Status: Recruiting
• Conditions: Adolescent; Depressive Disorder; Anxiety
• Intervention / Treatment: Behavioral: Breathing Intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Boos; Phone Number: 715-464-8173; Email: boos.danielle@mayo.edu
• Study Contact Backup: Name: Marin Nycklemoe; Phone Number: 507-255-2814; Email: nycklemoe.marin@mayo.edu

Study Locations

• United States
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Recruiting
      • Mayo Clinic Health System-Albert Lea
      • Contact: Marin Nycklemoe; Phone Number: 507-255-2814
      • Principal Investigator: Nicholas Bormann, MD
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54703
      • Recruiting
      • Mayo Clinic Health System-Eau Claire Clinic
      • Contact: Danielle Boos; Phone Number: 715-464-8173
      • Principal Investigator: Pravesh Sharma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adolescents between the ages of 12 and 17 who have been diagnosed with a major depressive disorder (mild or moderate) and/or an anxiety disorder.
• Participants may have co-occurring mild to moderate alcohol or drug use problems, provided these do not require immediate specialized treatment or crisis intervention.
• All participants must be receiving care at one of two participating MCHS outpatient psychiatry clinics and may reside in rural area (RUCA code 4-10) or non-rural area.
• Participants must be able to read and understand English, and both parental or guardian consent and adolescent assent will be required.

Exclusion Criteria:

• Current suicidal ideation or self-harm behavior requiring immediate clinical intervention
• Presence of severe psychiatric comorbidities such as psychosis, bipolar disorder, depression with psychotic features, severe alcohol and drug use, or eating disorders.
• Participants with significant cognitive impairment that would interfere with study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rural adolescent patients; Rural and non-rural adolescent patients of Mayo Clinic Health Systems, aged 12 to 17 years, with a clinical diagnosis of mild to moderate anxiety and/or depression will follow a structured breathing practice (Seokmun Hoheup) at least 3 times per week.	Behavioral: Breathing Intervention; Participants will follow a structured breathing practice (Seokmun Hoheup) that progresses in incremental steps, beginning with 15 minutes, increasing to 30 minutes, and then to 36 minutes per session over the course of the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure (FIM) score	The Feasibility of Intervention Measure (FIM) is a self-reported questionnaire for participants to rate the feasibility of the breathing practice intervention on a 5-point Likert scale. Possible scores range from 0 (Completely Disagree) to 5 (Completely Agree)	4 months
Acceptability of Intervention Measure (AIM) score	The Acceptability of Intervention Measure (AIM) is a self-reported, 4 question survey, for participants to rate their acceptance of the breathing practice intervention on a 5-point Likert scale. Possible scores range from 0 (Completely Disagree) to 5 (Completely Agree)	4 months
Intervention Appropriateness Measure (IAM) score	The Intervention Appropriateness Measure (IAM) is a self-reported, 4 question survey, for participants to rate the appropriateness of the breathing practice intervention on a 5-point Likert scale. Possible scores range from 0 (Completely Disagree) to 5 (Completely Agree)	4 months
Recruitment feasibility	Proportion of eligible adolescents enrolled out of total participants screened	4 months
Retention feasibility	Proportion of participants retained through final assessment out of total enrolled	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS) score	Digital usability will be assessed using the System Usability Scale (SUS) tool, a self-reported 10 question survey, for participants to rate the usability of the digital app platform on a 5-point Likert scale. Possible scores range from 0 (Completely Disagree) to 5 (Completely Agree)	4 months
Total number of log-ins	Total number of times participants logged into the digital app platform	4 months
Completion rate of assigned breathing practices	Adherence to breathing practice and intervention engagement will be assessed as the completion rate of assigned sessions as measured by the session attendance logs	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of collecting physiological data from baseline to 4 months	Feasibility will be assessed based on data completeness, participant tolerance, and procedural viability from those undergoing fNIRS or MRI testing.	Baseline to 4 months
Feasibility of collecting psychological data	Feasibility will be assessed by focusing on data completeness of validated mental health measures to include GHQ, GAD, PHQ-9.	Baseline to 4 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Pravesh Sharma, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breathing; Seokmun Hoheup
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Mood Disorders; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Depressive Disorder; Respiratory Aspiration
• Other Study ID Numbers: 25-012922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No