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NCT Number: NCT07369752

Enhancing Brain And Mental Health Through Breathing Practice

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.

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Key information

Conditions

Depressive Disorder Adolescent Anxiety Anxiety Disorders Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System-Albert Lea, Albert Lea, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Intervention Measure (FIM) score

    Time frame: 4 months

    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)

  2. Acceptability of Intervention Measure (AIM) score

    Time frame: 4 months

    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)

  3. Intervention Appropriateness Measure (IAM) score

    Time frame: 4 months

    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. Recruitment feasibility

    Time frame: 4 months

    Proportion of eligible adolescents enrolled out of total participants screened

  5. Retention feasibility

    Time frame: 4 months

    Proportion of participants retained through final assessment out of total enrolled

Secondary outcomes

  1. System Usability Scale (SUS) score

    Time frame: 4 months

    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)

  2. Total number of log-ins

    Time frame: 4 months

    Total number of times participants logged into the digital app platform

  3. Completion rate of assigned breathing practices

    Time frame: 4 months

    Adherence to breathing practice and intervention engagement will be assessed as the completion rate of assigned sessions as measured by the session attendance logs

Other outcomes

  1. Feasibility of collecting physiological data from baseline to 4 months

    Time frame: Baseline to 4 months

    Feasibility will be assessed based on data completeness, participant tolerance, and procedural viability from those undergoing fNIRS or MRI testing.

  2. Feasibility of collecting psychological data

    Time frame: Baseline to 4 months

    Feasibility will be assessed by focusing on data completeness of validated mental health measures to include GHQ, GAD, PHQ-9.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Boos

CONTACT

[email protected]

715-464-8173

Marin Nycklemoe

CONTACT

[email protected]

507-255-2814

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Apr 3, 2026

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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