Testing myWHI: Online Self-help Programs for Headaches

IWK Health Centre

Status: Unknown

Conditions: Migraine Disorders

Treatments: Behavioral: SPHERE; Behavioral: PRISM

Study type: Interventional

Funder types: Other

Identifiers

NCT03504150

1022640

Details and patient eligibility

About

This randomized controlled trial will compare the effectiveness of two online self-guided programs for youth and young adults with migraine against usual care.

Enrollment: 424 estimated patients

Sex: All

Ages: 14 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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424 participants in 3 patient groups

SPHERE

Experimental group

Description:

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.

Treatment:

Behavioral: SPHERE

PRISM

Experimental group

Description:

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.

Treatment:

Behavioral: PRISM

Usual care

No Intervention group