Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
424 participants
INTERVENTIONAL
2018-05-04
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
SPHERE
Comprehensive Internet-based CBT program with no human support
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.
PRISM
Brief Internet-based CBT program with no human support
Usual care
No interventions assigned to this group
Interventions
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SPHERE
Comprehensive Internet-based CBT program with no human support
PRISM
Brief Internet-based CBT program with no human support
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
14 Years
40 Years
ALL
Yes
Sponsors
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Nova Scotia Health Research Foundation
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
IWK Health Centre
OTHER
Responsible Party
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Anna Huguet
Principal investigator
Principal Investigators
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Anna Huguet, PhD
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Locations
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IWK Health Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1022640
Identifier Type: -
Identifier Source: org_study_id
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