Enhancing Brain And Mental Health Through Breathing Practice

NCT07369752 | Recruiting

• 1 other identifier: 25-012922
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depressive Disorder; Anxiety; Adolescent

Keywords

Seokmun Hoheup; breathing

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• System Usability Scale (SUS) score

  4 months

• Total number of log-ins

  4 months

• Completion rate of assigned breathing practices

  4 months

Other Outcomes (2)

• Feasibility of collecting physiological data from baseline to 4 months

  Baseline to 4 months

• Feasibility of collecting psychological data

  Baseline to 4 months

Study Arms (1)

Rural adolescent patients

EXPERIMENTAL

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

Interventions

Breathing Intervention BEHAVIORAL

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.

Rural adolescent patients

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Health System-Albert Lea

Albert Lea, Minnesota, 56007, United States

RECRUITING

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54703, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pravesh Sharma

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Boos

CONTACT

715-464-8173; boos.danielle@mayo.edu

Marin Nycklemoe

CONTACT

507-255-2814; nycklemoe.marin@mayo.edu

Study Design

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

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)