Adolescent, Anxiety, Depressive Disorder
Conditions
Keywords
Seokmun Hoheup, breathing
Brief 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.
Interventions
BEHAVIORALBreathing 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) score | 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 | 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 | 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 | 4 months | Proportion of eligible adolescents enrolled out of total participants screened |
| Retention feasibility | 4 months | Proportion of participants retained through final assessment out of total enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) score | 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) |
| Total number of log-ins | 4 months | Total number of times participants logged into the digital app platform |
| Completion rate of assigned breathing practices | 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 |
Countries
United States
Contacts
CONTACTDanielle Boos
CONTACTMarin Nycklemoe
PRINCIPAL_INVESTIGATORPravesh Sharma
Mayo Clinic
Outcome results
None listed