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Testing myWHI: Online Self-help Programs for Headaches

Not Applicable
Conditions
Migraine Disorders
Registration Number
NCT03504150
Lead Sponsor
IWK Health Centre
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
424
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomizationAt baseline and at 4-months post-randomization

An electronic headache diary will be asked to be used for 4 weeks. Each day participants will be asked to record whether or not they have experienced a headache.

Secondary Outcome Measures
NameTimeMethod
Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomizationAt baseline and at 4-months post-randomization

An electronic headache diary will be asked to be used for 4 weeks. On days that participants report a headache(s) in the diary, they will be asked to rate highest headache intensity for the day using the 11-point Numerical Rating Scale (NRS-11). The peak headache severity will be calculated in two different ways: (1) the average of the highest headache intensity per week over the 4-week period, and (2) the number of days that participants have reported a headache episode with a NRS-11 of 8 or higher over the 4-week period.

Statistically significant improvement in headache-related functional impairment from baseline to 4-months post-randomizationAt baseline and at 4-months post-randomization

We will measure impairment with either the Migraine Disability Assessment Scale -Pediatric version (PedMIDAS) for ages 14-18 years or the Migraine Disability Assessment Scale (MIDAS) for ages 19-40 years. MIDAS and PedMIDAS measure headache-related functional impairment. We will use the total score, which is the sum of answers across the 6 items for PedMIDAS and the sum of answers across the 5 items for MIDAS. A higher score indicating greater impairment.

Statistically significant improvement in depressive symptomatology from baseline to 4-months post-randomization.At baseline and at 4-months post-randomization

The Centre for Epidemiological Studies - Depression Scale (CES-D) will be used to measure depressive symptomatology. Responses will be summed to provide a total score that can range from 0 to 60; with higher scores indicating the presence of more symptoms and higher frequency.

Level of acceptability to the treatments (i.e., PRISM and SPHERE)At 4-months post-randomization

The single-item Patients' Global Impression of Change (PGIC) Scale will be used to measure level of acceptability to the treatments. The PGIC is 7-point categorical scale ("very much improved" to "very much worse") to report the perceived improvement with an intervention.

Trial Locations

Locations (1)

IWK Health Centre

🇨🇦

Halifax, Nova Scotia, Canada

IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Anna Huguet, PhD
Contact
anna.huguet@iwk.nshealth.ca
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