Testing myWHI: Online Self-help Programs for Headaches
- Conditions
- Migraine Disorders
- Interventions
- Behavioral: SPHEREBehavioral: 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPHERE 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. PRISM 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.
- Primary Outcome Measures
Name Time Method Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomization At 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
Name Time Method Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomization At 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-randomization At 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