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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 : October 16, 2018
Sponsor:
Collaborators:
Nova Scotia Health Research Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Anna Huguet, IWK Health Centre

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE May 4, 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03504150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing myWHI: Online Self-help Programs for Headaches
Official Title  ICMJE Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE
  • Behavioral: SPHERE
    Comprehensive Internet-based CBT program with no human support
  • Behavioral: PRISM
    Brief Internet-based CBT program with no human support
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: SPHERE
  • 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.
    Intervention: Behavioral: PRISM
  • No Intervention: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2018)
424
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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

Ages  ICMJE 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anna Huguet, PhD (902)470-3912 anna.huguet@iwk.nshealth.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504150
Other Study ID Numbers  ICMJE 1022640
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anna Huguet, IWK Health Centre
Study Sponsor  ICMJE IWK Health Centre
Collaborators  ICMJE
  • Nova Scotia Health Research Foundation
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Anna Huguet, PhD IWK Health Centre
PRS Account IWK Health Centre
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP