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Testing myWHI: Online Self-help Programs for Headaches

Not Applicable
Conditions
Migraine Disorders
Interventions
Behavioral: SPHERE
Behavioral: PRISM
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
Arm && Interventions
GroupInterventionDescription
SPHERESPHEREIt 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.
PRISMPRISMIt 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.
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

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