Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine
试验速览
- 阶段
- 不适用
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomization
研究概览
简要总结
This randomized controlled trial will compare the effectiveness of two online self-guided programs for youth and young adults with migraine against usual care.
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
- None
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SPHERE
It is an online self-guided comprehensive cognitive-behavioural therapy program that offers a headache diary, learning modules that teach a variety of cognitive and behavioural skills to cope better with their headaches, and a discussion forum where users may interact.
干预措施: SPHERE (Behavioral)
PRISM
It is an online self-guided brief cognitive-behavioural therapy program that offers a headache diary and helps users discover their headache triggers and non-triggers. Then the program provides the users with a few personalized recommendations to help them to cope with their triggers.
干预措施: PRISM (Behavioral)
Usual care
结局指标
主要结局
Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomization
时间窗: At baseline and at 4-months post-randomization
An electronic headache diary will be asked to be used for 4 weeks. Each day participants will be asked to record whether or not they have experienced a headache.
次要结局
- Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomization(At baseline and at 4-months post-randomization)
- Statistically significant improvement in headache-related functional impairment from baseline to 4-months post-randomization(At baseline and at 4-months post-randomization)
- Statistically significant improvement in depressive symptomatology from baseline to 4-months post-randomization.(At baseline and at 4-months post-randomization)
- Level of acceptability to the treatments (i.e., PRISM and SPHERE)(At 4-months post-randomization)
研究者
Anna Huguet
Principal investigator
IWK Health Centre