Testing myWHI: Online Self-help Programs for Headaches

NCT03504150 | Unknown

• 1 other identifier: 1022640
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomization

  At baseline and at 4-months post-randomization

• Statistically significant improvement in headache-related functional impairment from baseline to 4-months post-randomization

  At baseline and at 4-months post-randomization

• Statistically significant improvement in depressive symptomatology from baseline to 4-months post-randomization.

  At baseline and at 4-months post-randomization

• Level of acceptability to the treatments (i.e., PRISM and SPHERE)

  At 4-months post-randomization

• Level of acceptability to the treatments (i.e., PRISM and SPHERE)

  At 4-months post-randomization

Study Arms (3)

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.

Behavioral: SPHERE

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.

Behavioral: PRISM

Usual care

NO INTERVENTION

Interventions

SPHERE BEHAVIORAL

Comprehensive Internet-based CBT program with no human support

SPHERE

PRISM BEHAVIORAL

Brief Internet-based CBT program with no human support

PRISM

Eligibility Criteria

• Age: 14 Years - 40 Years
• Gender Eligibility Details: Participants will be asked: Are you: Male, Female, or I do not want to answer this question
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead
• Nova Scotia Health Research Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anna Huguet, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Huguet, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 20, 2018
• Study Start: May 4, 2018
• Primary Completion: October 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)