Migraine HeadacheNCT02710942
Testing myWHI: Online Self-guided Programs for Migraine
A study testing SPHERE and PRISM in people with Migraine Headache, run by IWK Health Centre at 1 site in Canada.
Trial summary
The goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. The programs are part of the investigators' collection of "my Wireless Headache Interventions" (myWHI). Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Migraine Headache
- 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
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2016
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 14-35 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
- use the Smartphone for activities other than texting and calling (e.g., email, Facebook)
- have daily Internet access from their Smartphone
- minimum of four headache days during 4 weeks of using 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
- have an impairment which compromises their ability to give informed consent
- having been diagnosed with psychosis and/or schizophrenia
- they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial
The goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. The programs are part of the investigators' collection of "my Wireless Headache Interventions" (myWHI). The Specialized Program for Headache Reduction (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users to discover their headache triggers and provides recommendations for managing them. This pilot will also assess the feasibility of the study protocol to inform a full scale randomized controlled trial (RCT).
- Conditions
- Migraine Headache
- 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
PRISMBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SPHERE intervention | Experimental | It is a comprehensive self-guided Internet-based cognitive-behavioral therapy (CBT) that includes three components: (1) the myWHI diary. (2) 30 multi-media learning topics that the user is encouraged to go through in a sequential way. The topics contain education information and teach strategies to cope better with their headaches. Receives: Behavioral: SPHERE |
| PRISM intervention | Experimental | It is a targeted self-guided Internet-based CBT intervention. PRISM was built upon the myWHI diary, an electronic headache diary. PRISM helps users discover their headache triggers by analyzing the inputted diary data using association rule mining. Once one or multiple headache triggers are identified the application uses an algorithm to provide the user with a few personalized recommendations to help them to cope with these triggers. The algorithm is based on the opinion of clinical experts (e.g., medical health professionals, psychologists). The user chooses recommendations to follow and sets goals in the application to follow them. To support the process, the application checks in with users about their goals and tracks goal completion. Receives: Behavioral: PRISM |
| Usual care | No intervention | Participants can continue doing what they usually do to deal with their migraines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of individuals who complete the online screening per month
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Measured: After reaching our desired sample size for randomization
Proportion of recruited participants who are eligible for study entry
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Measured: After reaching our desired sample size for randomization
Proportion of eligible participants who consent
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Measured: After reaching our desired sample size for randomization
Proportion of consented participants who are randomized
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Measured: After reaching our desired sample size for randomization
Proportion of randomized participants who drop out
Measured: At 4-month post-randomization
Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically
Measured: At 4-month post-randomization
Proportion of consented participants who complete the baseline assessment
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Measured: After reaching our desired sample size for randomization
Proportion of randomized participants who complete the 4-month post-randomization assessment
Measured: At 4-month post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)
Measured: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)
Measured: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews
Measured: At 4-mont post-randomization
Proportion of participants in the control group who show clinically significant improvement (50% or greater reduction) from baseline in number of headache days in the last 4 weeks
Measured: At 4-mont post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- 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
- NCT02710942
- Sponsor's protocol ID
- PSO-EST-2014-9575
- Status last verified
- Oct 2018
- First submitted
- 12 Nov 2015
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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
- Testing the Feasibility of Two Self-guided Web-based Interventions for Adolescents and Young Adults With Migraine: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02710942
- Acronym / sponsor ID
- PSO-EST-2014-9575
- Conditions
- Migraine Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Mar 2016 (estimated)
- 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.
The goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. The programs are part of the investigators' collection of "my Wireless Headache Interventions" (myWHI). The Specialized Program for Headache Reduction (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users to discover their headache triggers and provides recommendations for managing them. This pilot will also assess the feasibility of the study protocol to inform a full scale randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPHERE intervention | Experimental | Behavioral: SPHEREIt is a comprehensive self-guided Internet-based cognitive-behavioral therapy (CBT) that includes three components: (1) the myWHI diary. (2) 30 multi-media learning topics that the user is encouraged to go through in a sequential way. The topics contain education information and teach strategies to cope better with their headaches. |
| PRISM intervention | Experimental | Behavioral: PRISMIt is a targeted self-guided Internet-based CBT intervention. PRISM was built upon the myWHI diary, an electronic headache diary. PRISM helps users discover their headache triggers by analyzing the inputted diary data using association rule mining. Once one or multiple headache triggers are identified the application uses an algorithm to provide the user with a few personalized recommendations to help them to cope with these triggers. The algorithm is based on the opinion of clinical experts (e.g., medical health professionals, psychologists). The user chooses recommendations to follow and sets goals in the application to follow them. To support the process, the application checks in with users about their goals and tracks goal completion. |
| Usual care | No intervention | –Participants can continue doing what they usually do to deal with their migraines. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- aged 14-35 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
Key exclusion criteria (5 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
- have an impairment which compromises their ability to give informed consent
- having been diagnosed with psychosis and/or schizophrenia
- they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy
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 |
|---|---|---|
| SPHERE | Behavioural | SPHERE intervention |
| PRISM | Behavioural | PRISM intervention |
Primary outcome
Average number of individuals who complete the online screening per month
Time frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of recruited participants who are eligible for study entry
Time frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of eligible participants who consent
Time frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of consented participants who are randomized
Time frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of randomized participants who drop out
Time frame: At 4-month post-randomization
Level of usage of the Internet-based interventions (i.e., PRISM and SPHERE). Intervention usage will be tracked automatically
Time frame: At 4-month post-randomization
Proportion of consented participants who complete the baseline assessment
Time frame: After reaching our desired sample size for randomization
This is an exploratory study and we do not know how much time it will take for us to recruit our desired sample size. However, our maximum time frame is 1 year.
Proportion of randomized participants who complete the 4-month post-randomization assessment
Time frame: At 4-month post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the 8-item Client Satisfaction Questionnaire (CSQ-8)
Time frame: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the single-item Patients' Global Impression of Change Scale (PGIC)
Time frame: At 4-mont post-randomization
Acceptability of the Internet-based interventions (i.e., PRISM and SPHERE) using the satisfaction interviews
Time frame: At 4-mont post-randomization
Proportion of participants in the control group who show clinically significant improvement (50% or greater reduction) from baseline in number of headache days in the last 4 weeks
Time frame: At 4-mont post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Headache, 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 8 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of individuals who complete the online screening per month (time frame: After reaching our desired sample size for randomization). The study lists 12 primary outcomes in all. 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.