Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility (Primary)
研究概览
简要总结
The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable:
- Telehealth group mindfulness-based intervention
- Telehealth group headache education
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 examining an MBI that was adapted specifically for adolescents with migraine. This a pilot randomized controlled trial is designed to test feasibility and acceptability in preparation for a future efficacy trial. Adolescents with migraine will be randomized to one of two 6-week telehealth group programs: a mindfulness-based intervention (BREATHE-Headache) or Enhanced Standard-of-Care (a headache education program). Participants (and their parent/guardian) will complete assessments at baseline, immediately post-intervention, and 12-week follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age 12 to 17 years old
- •Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
- •Patient report of at least 6 headache days per month
- •At least mild headache-related disability, as assessed by PedMIDAS score > 10
- •Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment
- •Adolescent participant fluent in English for the intervention content
排除标准
- •Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months
- •Current psychiatric crisis (e.g., active suicidal ideation)
- •Cognitive impairments or developmental delays that interfere with their ability to participate in the study
- •Inability to provide consent/assent
研究组 & 干预措施
BREATHE with Headache (BREATHE-HA)
Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program
干预措施: BREATHE with Headache (BREATHE-HA) (Behavioral)
Enhanced Standard-of-Care: Headache Education
Headache education, delivered as a telehealth group program
干预措施: Enhanced Standard-of-Care: Headache Education (Behavioral)
结局指标
主要结局
Recruitment Feasibility (Primary)
时间窗: 24 months
≥ 80% of adolescents screened eligible will agree to participate
次要结局
- Recruitment Feasibility (Secondary)(24 months)
- Retention (Secondary)(Post-intervention (1 week after final intervention session); 12-week follow-up)
- Intervention Adherence (Secondary)(6 weeks)
- Acceptability (Secondary)(Post-intervention (1 week after final intervention session))
- Protocol Feasibility (Secondary)(Baseline, post-intervention (1 week after final intervention session), 12-week follow-up)
- Intervention Fidelity (Secondary)(6 weeks)