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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
IWK Health Centre
Halifax, Nova Scotia, Canada
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.
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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