Migraine Headache
Conditions
Brief summary
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).
Sponsors
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average number of individuals who complete the online screening per month | 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 | 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 eligible participants who consent | 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 are randomized | 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 randomized participants who drop out | At 4-month post-randomization | — |
| Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically | At 4-month post-randomization | — |
| Proportion of consented participants who complete the baseline assessment | 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 randomized participants who complete the 4-month post-randomization assessment | 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) | 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) | At 4-mont post-randomization | — |
| Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews | 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 | At 4-mont post-randomization | — |
Countries
Canada
Outcome results
None listed