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| Name | Class |
|---|---|
| Nova Scotia Health Research Foundation | OTHER_GOV |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This randomized controlled trial will compare the effectiveness of two online self-guided programs for youth and young adults with migraine against usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPHERE | Experimental | 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. |
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| PRISM | Experimental | 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. |
|
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPHERE | Behavioral | Comprehensive Internet-based CBT program with no human support |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 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. | At baseline and at 4-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant improvement in peak headache severity in a 4-week period from baseline to 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. |
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Inclusion criteria:
Exclusion criteria:
Participants will be asked:
Are you: Male, Female, or I do not want to answer this question
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Huguet, PhD | Contact | (902)470-3912 | anna.huguet@iwk.nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anna Huguet, PhD | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| PRISM |
| Behavioral |
Brief Internet-based CBT program with no human support |
|
| At baseline and at 4-months post-randomization |
| Statistically significant improvement in headache-related functional impairment from baseline to 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. | At baseline and at 4-months post-randomization |
| Statistically significant improvement in depressive symptomatology from baseline to 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. | At baseline and at 4-months post-randomization |
| Level of acceptability to the treatments (i.e., PRISM and SPHERE) | The 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to measure level of acceptability to the treatments. The total score will be used. The total score is the sum of item responses and ranges from 8 to 32, with higher scores indicating higher levels of satisfaction. | At 4-months post-randomization |
| Level of acceptability to the treatments (i.e., PRISM and SPHERE) | 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. | At 4-months post-randomization |
| D009422 | Nervous System Diseases |