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RecruitingNCT07369752Updated Apr 3, 2026

Enhancing Brain And Mental Health Through Breathing Practice

An interventional study of Breathing Intervention in Depressive Disorder, Anxiety and Adolescent, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Disorder
  • Anxiety
  • Adolescent

Keywords

  • Seokmun Hoheup
  • breathing
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralBreathing 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4 months

  2. 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)

    Time frame: 4 months

  3. 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)

    Time frame: 4 months

  4. Recruitment feasibility

    Proportion of eligible adolescents enrolled out of total participants screened

    Time frame: 4 months

  5. Retention feasibility

    Proportion of participants retained through final assessment out of total enrolled

    Time frame: 4 months

Secondary outcomes

  1. 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)

    Time frame: 4 months

  2. Total number of log-ins

    Total number of times participants logged into the digital app platform

    Time frame: 4 months

  3. 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

    Time frame: 4 months

Other outcomes

  1. 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.

    Time frame: Baseline to 4 months

  2. 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.

    Time frame: Baseline to 4 months

07

Study locations

2 of 2 sites recruiting
  • Mayo Clinic Health System-Albert Lea
    Albert Lea, Minnesota 56007, United States
    • Marin Nycklemoe · Contact · 507-255-2814
    • Nicholas Bormann, MD · Principal investigator
    Recruiting
  • Mayo Clinic Health System-Eau Claire Clinic
    Eau Claire, Wisconsin 54703, United States
    • Danielle Boos · Contact · 715-464-8173
    • Pravesh Sharma, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07369752
Lead sponsor
Mayo Clinic
Responsible party
Pravesh Sharma (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 27, 2026
Start date
Feb 19, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Danielle Boos
Contact
boos.danielle@mayo.edu
715-464-8173
Marin Nycklemoe
Contact
nycklemoe.marin@mayo.edu
507-255-2814
Pravesh Sharma
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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