An interventional study of SPHERE and PRISM in Migraine Headache, sponsored by IWK Health Centre. Completed at 1 site in Canada. Open to participants aged 14 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by IWK Health Centre · Not applicable, Interventional, and Treatment
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).
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →IWK Health Centre is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: SPHERE
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.
Behavioral: PRISM
Participants can continue doing what they usually do to deal with their migraines.
Average number of individuals who complete the online screening per month
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.
Time frame: After reaching our desired sample size for randomization
Proportion of recruited participants who are eligible for study entry
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.
Time frame: After reaching our desired sample size for randomization
Proportion of eligible participants who consent
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.
Time frame: After reaching our desired sample size for randomization
Proportion of consented participants who are randomized
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.
Time frame: After reaching our desired sample size for randomization
Proportion of randomized participants who drop out
Time frame: At 4-month post-randomization
Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically
Time frame: At 4-month post-randomization
Proportion of consented participants who complete the baseline assessment
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.
Time frame: After reaching our desired sample size for randomization
Proportion of randomized participants who complete the 4-month post-randomization assessment
Time frame: 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)
Time frame: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)
Time frame: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews
Time frame: At 4-mont 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
Time frame: At 4-mont post-randomization
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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IWK Health Centre