Enhancing Brain And Mental Health Through Breathing Practice: Clinical Applications In Rural Adolescents With Psychiatric Symptoms (Breathing Study -Adolescent)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention Measure (FIM) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Rural adolescent patients
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.
干预措施: Breathing Intervention (Behavioral)
结局指标
主要结局
Feasibility of Intervention Measure (FIM) score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 4 months
Proportion of eligible adolescents enrolled out of total participants screened
Retention feasibility
时间窗: 4 months
Proportion of participants retained through final assessment out of total enrolled
次要结局
- System Usability Scale (SUS) score(4 months)
- Total number of log-ins(4 months)
- Completion rate of assigned breathing practices(4 months)
研究者
Pravesh Sharma
Principal Investigator
Mayo Clinic