Clinical trial NCT03504150: Testing myWHI: Online Self-help Programs for Headaches
Official title: Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Disorders
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Research Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-04-20
Enrollment: 424
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will compare the effectiveness of two online self-guided programs for youth and young adults with migraine against usual care.


Eligibility criteria: Inclusion criteria:

* aged 14-40 years
* 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:

* 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, 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

Primary outcomes:
measure: Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomization
timeFrame: At baseline and at 4-months post-randomization
Secondary outcomes:
measure: Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomization
timeFrame: At baseline and at 4-months post-randomization
measure: Statistically significant improvement in headache-related functional impairment from baseline to 4-months post-randomization
timeFrame: At baseline and at 4-months post-randomization
measure: Statistically significant improvement in depressive symptomatology from baseline to 4-months post-randomization.
timeFrame: At baseline and at 4-months post-randomization
measure: Level of acceptability to the treatments (i.e., PRISM and SPHERE)
timeFrame: At 4-months post-randomization
measure: Level of acceptability to the treatments (i.e., PRISM and SPHERE)
timeFrame: At 4-months post-randomization
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Anna Huguet, PhD
role: PRINCIPAL_INVESTIGATOR
References: