Enhancing Brain And Mental Health Through Breathing Practice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Breathing Intervention
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Rural adolescent patientsExperimental treatment 1 intervention
Trial outcomes
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 months2
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 months3
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 months4
Recruitment feasibility
Proportion of eligible adolescents enrolled out of total participants screened
Time frame
4 monthsSecondary 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 months2
Total number of log-ins
Total number of times participants logged into the digital app platform
Time frame
4 months3
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 monthsOther 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 months2
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov