Depressive DisorderNCT07369752
Enhancing Brain And Mental Health Through Breathing Practice
A study testing Breathing Intervention in people with Depressive Disorder and Anxiety, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depressive Disorder, Anxiety, Adolescent
- What is being tested?
- Breathing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic Health System-Albert Lea
Albert Lea, Minnesota, 56007
Marin Nycklemoe, 507-255-2814
Nicholas Bormann, MD
- Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54703
Danielle Boos, 715-464-8173
Pravesh Sharma, MD
About this study
Official title: Enhancing Brain And Mental Health Through Breathing Practice: Clinical Applications In Rural Adolescents With Psychiatric Symptoms (Breathing Study -Adolescent)
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
- Being tested
- Breathing Intervention
- Keywords
- Seokmun Hoheup, breathing
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breathing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 4 months
Recruitment feasibility
Proportion of eligible adolescents enrolled out of total participants screened
Measured: 4 months
Retention feasibility
Proportion of participants retained through final assessment out of total enrolled
Measured: 4 months
Secondary outcomes (3)
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)
Measured: 4 months
Total number of log-ins
Total number of times participants logged into the digital app platform
Measured: 4 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start19 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pravesh Sharma, Mayo Clinic
- Investigators
- Pravesh Sharma, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369752
- Sponsor's protocol ID
- 25-012922
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain And Mental Health Through Breathing Practice: Clinical Applications In Rural Adolescents With Psychiatric Symptoms (Breathing Study -Adolescent)
- ClinicalTrials.gov ID
- NCT07369752
- Acronym / sponsor ID
- 25-012922
- Conditions
- Depressive Disorder, Anxiety, Adolescent
- Keywords
- Seokmun Hoheup, breathing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rural adolescent patients | Experimental | Behavioral: Breathing InterventionRural 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing InterventionParticipants 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. | Behavioural | Rural adolescent patients |
Primary outcome
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)
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)
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)
Recruitment feasibility
Time frame: 4 months
Proportion of eligible adolescents enrolled out of total participants screened
Retention feasibility
Time frame: 4 months
Proportion of participants retained through final assessment out of total enrolled
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pravesh Sharma principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Intervention in people with Depressive Disorder and Anxiety, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Boos (715-464-8173, boos.danielle@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM) score (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.