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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 4 months |
| Recruitment feasibility | Proportion of eligible adolescents enrolled out of total participants screened | 4 months |
| Retention feasibility | Proportion of participants retained through final assessment out of total enrolled | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 4 months |
| Feasibility of collecting psychological data |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Boos | Contact | 715-464-8173 | boos.danielle@mayo.edu | |
| Marin Nycklemoe | Contact | 507-255-2814 | nycklemoe.marin@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pravesh Sharma | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System-Albert Lea | Recruiting | Albert Lea | Minnesota | 56007 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Total number of log-ins |
Total number of times participants logged into the digital app platform |
| 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 | 4 months |
Feasibility will be assessed by focusing on data completeness of validated mental health measures to include GHQ, GAD, PHQ-9. |
| Baseline to 4 months |
| Mayo Clinic Health System-Eau Claire Clinic | Recruiting | Eau Claire | Wisconsin | 54703 | United States |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |