Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of consented participants who are randomized
研究概览
简要总结
The goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. The programs are part of the investigators' collection of "my Wireless Headache Interventions" (myWHI). The Specialized Program for Headache Reduction (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users to discover their headache triggers and provides recommendations for managing them. This pilot will also assess the feasibility of the study protocol to inform a full scale randomized controlled trial (RCT).
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 (Investigator)
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 14-35 years
- •fluent in the English language (i.e., speaking, reading and writing);
- •suffer from headaches for a minimum of one year
- •stable pattern of headache symptoms (e.g., headache frequency, severity, location of pain, symptoms associated with headache) for the past 6 months
- •suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine
- •use the Smartphone for activities other than texting and calling (e.g., email, Facebook)
- •have daily Internet access from their Smartphone
- •minimum of four headache days during 4 weeks of using 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
- •have an impairment which compromises their ability to give informed consent
- •having been diagnosed with psychosis and/or schizophrenia
- •they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy
研究组 & 干预措施
SPHERE intervention
It is a comprehensive self-guided Internet-based cognitive-behavioral therapy (CBT) that includes three components: (1) the myWHI diary. (2) 30 multi-media learning topics that the user is encouraged to go through in a sequential way. The topics contain education information and teach strategies to cope better with their headaches.
干预措施: SPHERE (Behavioral)
PRISM intervention
It is a targeted self-guided Internet-based CBT intervention. PRISM was built upon the myWHI diary, an electronic headache diary. PRISM helps users discover their headache triggers by analyzing the inputted diary data using association rule mining. Once one or multiple headache triggers are identified the application uses an algorithm to provide the user with a few personalized recommendations to help them to cope with these triggers. The algorithm is based on the opinion of clinical experts (e.g., medical health professionals, psychologists). The user chooses recommendations to follow and sets goals in the application to follow them. To support the process, the application checks in with users about their goals and tracks goal completion.
干预措施: PRISM (Behavioral)
Usual care
Participants can continue doing what they usually do to deal with their migraines.
结局指标
主要结局
Proportion of consented participants who are randomized
时间窗: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of consented participants who complete the baseline assessment
时间窗: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)
时间窗: At 4-mont post-randomization
Proportion of randomized participants who drop out
时间窗: At 4-month post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)
时间窗: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews
时间窗: At 4-mont post-randomization
Proportion of eligible participants who consent
时间窗: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Average number of individuals who complete the online screening per month
时间窗: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of recruited participants who are eligible for study entry
时间窗: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically
时间窗: At 4-month post-randomization
Proportion of randomized participants who complete the 4-month post-randomization assessment
时间窗: At 4-month post-randomization
Proportion of participants in the control group who show clinically significant improvement (50% or greater reduction) from baseline in number of headache days in the last 4 weeks
时间窗: At 4-mont post-randomization
次要结局
未报告次要终点
研究者
Anna Huguet
Research Scientist
IWK Health Centre