Back to resultsTesting myWHI: Online Self-help Programs for Headaches
Primary Purpose
Migraine Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SPHERE
PRISM
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility Criteria
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
Sites / Locations
- IWK Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
SPHERE
PRISM
Usual care
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Statistically significant improvement in peak headache severity 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. 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
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.
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)
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)
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.
Full Information
NCT ID
NCT03504150
First Posted
April 5, 2018
Last Updated
October 15, 2018
Sponsor
IWK Health Centre
Collaborators
Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT03504150
Brief Title
Testing myWHI: Online Self-help Programs for Headaches
Official Title
Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
Collaborators
Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPHERE
Arm Type
Experimental
Arm 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.
Arm Title
PRISM
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
SPHERE
Intervention Description
Comprehensive Internet-based CBT program with no human support
Intervention Type
Behavioral
Intervention Name(s)
PRISM
Intervention Description
Brief Internet-based CBT program with no human support
Primary Outcome Measure Information:
Title
Clinically significant improvement (50% reduction or greater) in number of headache days in a 4-week period from baseline to 4-months post-randomization
Description
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.
Time Frame
At baseline and at 4-months post-randomization
Secondary Outcome Measure Information:
Title
Statistically significant improvement in peak headache severity in a 4-week period from baseline to 4-months post-randomization
Description
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.
Time Frame
At baseline and at 4-months post-randomization
Title
Statistically significant improvement in headache-related functional impairment from baseline to 4-months post-randomization
Description
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.
Time Frame
At baseline and at 4-months post-randomization
Title
Statistically significant improvement in depressive symptomatology from baseline to 4-months post-randomization.
Description
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.
Time Frame
At baseline and at 4-months post-randomization
Title
Level of acceptability to the treatments (i.e., PRISM and SPHERE)
Description
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.
Time Frame
At 4-months post-randomization
Title
Level of acceptability to the treatments (i.e., PRISM and SPHERE)
Description
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.
Time Frame
At 4-months post-randomization
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants will be asked:
Are you: Male, Female, or I do not want to answer this question
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Huguet, PhD
Phone
(902)470-3912
Email
anna.huguet@iwk.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Huguet, PhD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Huguet, PhD
Email
anna.huguet@iwk.nshealth.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://mywhi.ca
Description
Study website
Learn more about this trial
Testing myWHI: Online Self-help Programs for Headaches
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