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Recruiting NCT07369752

Enhancing Brain And Mental Health Through Breathing Practice

No phase Interventional Depressive Disorder Anxiety Adolescent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breathing Intervention.
Who it may be relevant to
Registry conditions: Depressive Disorder, Anxiety, Adolescent. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility of Intervention Measure (FIM) score [Time frame: 4 months]
  • Acceptability of Intervention Measure (AIM) score [Time frame: 4 months]
  • Intervention Appropriateness Measure (IAM) score [Time frame: 4 months]
  • Recruitment feasibility [Time frame: 4 months]
  • Retention feasibility [Time frame: 4 months]
Secondary outcome measures (3)
  • System Usability Scale (SUS) score [Time frame: 4 months]
  • Total number of log-ins [Time frame: 4 months]
  • Completion rate of assigned breathing practices [Time frame: 4 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Mayo Clinic Health System-Albert Lea — Albert Lea
  • Mayo Clinic Health System-Eau Claire Clinic — Eau Claire

Identifiers

NCT: NCT07369752 · 25-012922

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗