Migraine DisordersNCT03504150
Testing myWHI: Online Self-help Programs for Headaches
A study testing SPHERE and PRISM in people with Migraine Disorders, run by IWK Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- SPHERE and PRISM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2018to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Anna Huguet, PhD, anna.huguet@iwk.nshealth.ca
About this study
Official title: Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine
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
- Being tested
- SPHERE, PRISM
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPHEREBehavioural
Comprehensive Internet-based CBT program with no human support
PRISMBehavioural
Brief Internet-based CBT program with no human support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PRISM |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At baseline and at 4-months post-randomization
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.
Measured: At baseline and at 4-months post-randomization
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.
Measured: At baseline and at 4-months post-randomization
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.
Measured: At 4-months post-randomization
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.
Measured: At 4-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start4 May 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Anna Huguet, IWK Health Centre
- Investigators
- Anna Huguet, PhD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504150
- Sponsor's protocol ID
- 1022640
- Status last verified
- Oct 2018
- First submitted
- 5 Apr 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Two Self-guided Web-based Interventions for Youth and Young Adults With Migraine
- ClinicalTrials.gov ID
- NCT03504150
- Acronym / sponsor ID
- 1022640
- Conditions
- Migraine Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- 4 May 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will compare the effectiveness of two online self-guided programs for youth and young adults with migraine against usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPHERE | Experimental | Behavioral: SPHEREIt 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. |
| PRISM | Experimental | Behavioral: PRISMIt 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. |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPHEREComprehensive Internet-based CBT program with no human support | Behavioural | SPHERE |
| PRISMBrief Internet-based CBT program with no human support | Behavioural | PRISM |
Primary outcome
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.
5 secondary outcomes
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
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
Statistically significant improvement in depressive symptomatology from baseline to 4-months post-randomization.
Time frame: At baseline and at 4-months post-randomization
Level of acceptability to the treatments (i.e., PRISM and SPHERE)
Time frame: At 4-months post-randomization
Level of acceptability to the treatments (i.e., PRISM and SPHERE)
Time frame: At 4-months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Huguet, PhD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPHERE and PRISM in people with Migraine Disorders, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Huguet, PhD ((902)470-3912, anna.huguet@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.