Mindfulness-Based Intervention for Adolescents With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Intervention feasibility
研究概览
简要总结
The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.
详细描述
Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 to 18 years
- •Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
- •Patient report of >= 8 headache days per month
- •PedMIDAS Score of > 10 (at least mild headache-related disability)
排除标准
- •Major comorbid medical condition (e.g., cancer, epilepsy)
- •Active psychosis or suicidal ideation
- •Inability to provide consent/assent
结局指标
主要结局
Intervention feasibility
时间窗: Up to 6 weeks
Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention)
Intervention acceptability
时间窗: 7 weeks
Ratings on program acceptability questionnaire (higher scores indicate higher acceptability); Qualitative data generated via focus group interviews (questions will include positive and negative perceptions of the intervention)
次要结局
- Change in headache-related disability(Baseline, 6 weeks)
- Change in emotion regulation(Baseline, 6 weeks)