Testing myWHI: Online Self-help Programs for Headaches
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03504150|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Behavioral: SPHERE Behavioral: PRISM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine|
|Actual Study Start Date :||May 4, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||May 1, 2020|
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.
Comprehensive Internet-based CBT program with no human support
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.
Brief Internet-based CBT program with no human support
|No Intervention: Usual care|
- Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomization [ Time Frame: 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.
- Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomization [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: At 4-months post-randomization ]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.
- Level of acceptability to the treatments (i.e., PRISM and SPHERE) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504150
|Contact: Anna Huguet, PhD||(902)firstname.lastname@example.org|
|Canada, Nova Scotia|
|IWK Health Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Contact: Anna Huguet, PhD email@example.com|
|Principal Investigator:||Anna Huguet, PhD||IWK Health Centre|