A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility in terms of recruitment and adherence rates
研究概览
简要总结
This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.
详细描述
After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -
- Choice Arm: allowed to choose from a menu of migraine behavioral treatment options
- Random: randomized to migraine behavioral treatment options.
After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have chronic migraine for a minimum of 1-year
- •aged 18 years and older
排除标准
- •secondary headache disorders
- •children younger than 18 years old
研究组 & 干预措施
Choice - MS
this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
干预措施: Migraine Behavioral Treatment (Behavioral)
Choice - SE
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise
干预措施: Migraine Behavioral Treatment (Behavioral)
Random - ME
participants will be randomized to an intervention involving regular mealtime and regular timed exercise
干预措施: Migraine Behavioral Treatment (Behavioral)
Random - MS
participants will be randomized to an intervention involving regular mealtime and regular sleep
干预措施: Migraine Behavioral Treatment (Behavioral)
Random - SE
participants will be randomized to an intervention involving regular sleep and regular timed exercise
干预措施: Migraine Behavioral Treatment (Behavioral)
Choice - ME
this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
干预措施: Migraine Behavioral Treatment (Behavioral)
结局指标
主要结局
Feasibility in terms of recruitment and adherence rates
时间窗: 12 weeks
recruitment rate, adherence rate
次要结局
- Migraine Frequency(at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization)
- Headache Self-efficacy(at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization)
- Migraine Intensity(at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization)
研究者
Yohannes Woubishet Woldeamanuel
Principal Investigator
Mayo Clinic