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
- 1
- 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
- •aged 14-40 years
- •fluent in the English language (i.e., speaking, reading and writing);
- •for 14-17 year olds: suffer from headaches for a minimum of three months
- •for 18-40 year olds: suffer from headaches for a minimum of one year
- •suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine
- •have a Smartphone as PRISM has been designed to be accessed from a Smartphone and SPHERE encompasses the myWHI diary which has also been designed to be used from a Smartphone
- •use the Smartphone for activities other than texting and calling (e.g., email, Facebook) as the programs are designed for migraineurs who are familiar with using Smartphones and use them in their daily life
- •have daily Internet access from their Smartphone, because running the programs require an Internet connection
- •minimum of four headache days during 4 weeks that they are asked to use an electronic headache diary
排除标准
- •health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis)
- •are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding, as hormonal changes are known to exert potent influences on migraine headaches
- •have an impairment which compromises their ability to give informed consent
- •having been diagnosed with psychosis and/or schizophrenia, because a past or current diagnosis may likely interfere with the participants ability to fully participate in the study
- •have participated in our recent three-armed pilot RCT (i.e., any participant who consented and was randomized)
- •they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy when they asked to use it for 4 weeks
- •More than 15 headache days during the 4 weeks that they are asked to use an electronic headache diary
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
- Level of acceptability to the treatments (i.e., PRISM and SPHERE)(At 4-months post-randomization)
- 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)
研究者
Anna Huguet
Principal investigator
IWK Health Centre