Recruiting

myWHI

Sponsor:

IWK Health Centre

Code:

NCT03504150

Conditions

Migraine Disorders

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Accepted

Interventions

SPHERE

PRISM

Study Details

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.

Conditions

Migraine Disorders

Study ID

NCT03504150

Start date

May 4, 2018

Status verified date

Oct, 2018

Completion date

May 1, 2020

Anticipated

Primary completion date

Oct 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

424 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

no intervention: Usual care

Interventions

SPHERE

Comprehensive Internet-based CBT program with no human support

PRISM

Brief Internet-based CBT program with no human support

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Anna Huguet, PhD

(902)470-3912anna.huguet@iwk.nshealth.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Anna Huguet, PhD

anna.huguet@iwk.nshealth.ca

More Information

Sponsor

IWK Health Centre

Last update posted

Oct 16, 2018

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2018-10-16.