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Testing myWHI: Online Self-help Programs for Headaches

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ClinicalTrials.gov Identifier: NCT03504150
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Nova Scotia Health Research Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Anna Huguet, IWK Health Centre

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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Behavioral: SPHERE Behavioral: PRISM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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.
Behavioral: SPHERE
Comprehensive Internet-based CBT program with no human support

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.
Behavioral: PRISM
Brief Internet-based CBT program with no human support

No Intervention: Usual care



Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Participants will be asked:

Are you: Male, Female, or I do not want to answer this question

Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • aged 14-40 years
  • fluent in the English language (i.e., speaking, reading and writing);
  • suffer from headaches for a minimum of one year
  • stable pattern of headache symptoms (e.g., headache frequency, severity, location of pain, symptoms associated with headache) for the past 6 months
  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Anna Huguet, PhD (902)470-3912 anna.huguet@iwk.nshealth.ca

Locations
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Anna Huguet, PhD       anna.huguet@iwk.nshealth.ca   
Sponsors and Collaborators
IWK Health Centre
Nova Scotia Health Research Foundation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anna Huguet, PhD IWK Health Centre

Additional Information:
Responsible Party: Anna Huguet, Principal investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03504150     History of Changes
Other Study ID Numbers: 1022640
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases