Testing myWHI: Online Self-help Programs for Headaches

Migraine Disorders Clinical Trial

Official title:

Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504150
• Other study ID #: 1022640
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: October 2018
• Source: IWK Health Centre
• Contact: Anna Huguet, PhD
• Phone: (902)470-3912
• Email: anna.huguet[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: May 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 40 Years

Eligibility

Inclusion criteria:

• aged 14-40 years

• fluent in the English language (i.e., speaking, reading and writing);

• for 14-17 year olds: suffer from headaches for a minimum of three months

• for 18-40 year olds: suffer from headaches for a minimum of one year

• suffer from migraine headaches as indicated with a score of 2 and above on the ID Migraine

• have a Smartphone as PRISM has been designed to be accessed from a Smartphone and SPHERE encompasses the myWHI diary which has also been designed to be used from a Smartphone

• use the Smartphone for activities other than texting and calling (e.g., email, Facebook) as the programs are designed for migraineurs who are familiar with using Smartphones and use them in their daily life

• have daily Internet access from their Smartphone, because running the programs require an Internet connection

• minimum of four headache days during 4 weeks that they are asked to use an electronic headache diary

Exclusion criteria:

• health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis)

• are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding, as hormonal changes are known to exert potent influences on migraine headaches

• have an impairment which compromises their ability to give informed consent

• having been diagnosed with psychosis and/or schizophrenia, because a past or current diagnosis may likely interfere with the participants ability to fully participate in the study

• have participated in our recent three-armed pilot RCT (i.e., any participant who consented and was randomized)

• they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy when they asked to use it for 4 weeks

• More than 15 headache days during the 4 weeks that they are asked to use an electronic headache diary

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Behavioral:
• SPHERE
Comprehensive Internet-based CBT program with no human support
• PRISM
Brief Internet-based CBT program with no human support

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
IWK Health Centre	Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	At baseline and at 4-months post-randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study website