Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
415 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-10-15
Study Completion Date
2027-06-02
Brief Summary
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Health enSuite is a suite of applications designed by our research team at the Centre of Research in Family Health at IWK Health. These applications evaluate virtual solutions for clinical problems and assist family doctors with their adult patients.
Health enSuite will be utilized by Canadian family physicians targeting insomnia, anxiety, migraine headache, and caregiver distress.
Health enSuite Migraine has been designed to make cognitive and behavioral techniques for managing migraine headache readily available to primary care patients. The online program combines treatment elements that are effective in preventing and managing migraine headache pain, including trigger management, stress management, relaxation techniques, cognitive reappraisal, and psychoeducation.
Health enSuite will be utilized by Canadian family physicians targeting insomnia, anxiety, migraine headache, and caregiver distress.
Health enSuite Migraine has been designed to make cognitive and behavioral techniques for managing migraine headache readily available to primary care patients. The online program combines treatment elements that are effective in preventing and managing migraine headache pain, including trigger management, stress management, relaxation techniques, cognitive reappraisal, and psychoeducation.
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Detailed Description
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Headaches are highly prevalent among Canadians and many people visit their primary care provider due to headache symptoms. Headaches can be classified based on frequency (acute, episodic, chronic) and symptom presentation (migraine headache, tension-type, cluster, etc.). Headaches are of concern to many people as the World Health Organization (WHO) has reported that in 2016, more than half of people around the world between 16-65 years old reported having headaches. Up to 70% of individuals experience tension headaches, and 8.3% of Canadians are affected by migraine headache.
Headache symptoms can last a few hours to several days and are debilitating as they cause significant pain and distress. Headaches can also negatively impact one's life as they cause problems related to work performance and/or school activities (i.e., not being able to complete an assignment or project on time).
People who seek medical attention from their primary care provider for their headache pain often have difficulty receiving adequate treatment. One of the barriers to the optimal treatment of headaches is that the availability of non-pharmacological, psychosocial treatments is very limited. Although medications can be an important part of effective headache management, the use of non-pharmacological treatments is widely recommended .
Among headache disorders, migraine headaches are particularly debilitating due to their neurological basis, severity, and high burden on daily functioning. Unlike tension-type headaches, migraine headaches involve additional symptoms such as nausea, photophobia, and phonophobia, leading to greater disability. Given this significant impact, our study focuses specifically on developing a digital Cognitive Behavioral Therapy (CBT) intervention for migraine headache sufferers.
The National Canadian Migraine Strategy has recommended self-management patient interventions and patient education to learn skills to manage their symptoms in partnership with their healthcare providers. They have also advocated for the use of non-pharmacological therapies like stress management, skills to avoid triggers causing migraine headache, relaxation therapies, and self-monitoring for the management of migraine headache as part of their chronic disease management program for migraine headache. Although many medications can reduce pain due to migraine headache, their frequent use has associated side effects, and the prolonged use or overuse of medications can also cause migraine headache. Thus, an overreliance on pharmacological treatments and a lack of attention to lifestyle and psychosocial factors contributing to migraine headache symptoms can create sub-optimal outcomes for patients. Therefore, our goal is to develop a CBT program for migraine headache that can be delivered through an internet-connected phone, tablet, or computer and provide effective treatment to a wide range of patients with migraine headache. Health enSuite is a suite of applications designed by our research team at the Centre of Research in Family Health at IWK Health. Health enSuite will be utilized by patients suffering from insomnia, anxiety, migraine headache, and caregiver distress.
Health enSuite Migraine has been designed to make cognitive and behavioral techniques for managing migraine headache readily available to people suffering from migraine headache. The online program combines treatment elements that are effective in preventing and managing migraine headache pain, including trigger management, stress management, relaxation techniques, cognitive reappraisal, and psychoeducation.
Headache symptoms can last a few hours to several days and are debilitating as they cause significant pain and distress. Headaches can also negatively impact one's life as they cause problems related to work performance and/or school activities (i.e., not being able to complete an assignment or project on time).
People who seek medical attention from their primary care provider for their headache pain often have difficulty receiving adequate treatment. One of the barriers to the optimal treatment of headaches is that the availability of non-pharmacological, psychosocial treatments is very limited. Although medications can be an important part of effective headache management, the use of non-pharmacological treatments is widely recommended .
Among headache disorders, migraine headaches are particularly debilitating due to their neurological basis, severity, and high burden on daily functioning. Unlike tension-type headaches, migraine headaches involve additional symptoms such as nausea, photophobia, and phonophobia, leading to greater disability. Given this significant impact, our study focuses specifically on developing a digital Cognitive Behavioral Therapy (CBT) intervention for migraine headache sufferers.
The National Canadian Migraine Strategy has recommended self-management patient interventions and patient education to learn skills to manage their symptoms in partnership with their healthcare providers. They have also advocated for the use of non-pharmacological therapies like stress management, skills to avoid triggers causing migraine headache, relaxation therapies, and self-monitoring for the management of migraine headache as part of their chronic disease management program for migraine headache. Although many medications can reduce pain due to migraine headache, their frequent use has associated side effects, and the prolonged use or overuse of medications can also cause migraine headache. Thus, an overreliance on pharmacological treatments and a lack of attention to lifestyle and psychosocial factors contributing to migraine headache symptoms can create sub-optimal outcomes for patients. Therefore, our goal is to develop a CBT program for migraine headache that can be delivered through an internet-connected phone, tablet, or computer and provide effective treatment to a wide range of patients with migraine headache. Health enSuite is a suite of applications designed by our research team at the Centre of Research in Family Health at IWK Health. Health enSuite will be utilized by patients suffering from insomnia, anxiety, migraine headache, and caregiver distress.
Health enSuite Migraine has been designed to make cognitive and behavioral techniques for managing migraine headache readily available to people suffering from migraine headache. The online program combines treatment elements that are effective in preventing and managing migraine headache pain, including trigger management, stress management, relaxation techniques, cognitive reappraisal, and psychoeducation.
Conditions
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Migraine
Migraine With Aura
Migraine Without Aura
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This project consists of a pragmatic randomized controlled trial (RCT). The Consolidated Standards of Reporting Trials (CONSORT) recommendations (http://www.consort-statement.org/) will guide the methodology. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in both groups will complete self-assessments including key outcome measures at baseline before starting the study, at two months post-randomization, and again at six months post-randomization. Participants in the intervention group will receive the full Health enSuite Migraine program described below immediately after being randomized to this group. Participants in the waitlist control group will be waitlisted during the study. After their participation in the study has ended, participants in the waitlist control group will be given access to the full Health enSuite Migraine program for two months.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intervention
Health enSuite: Migraine has been designed based on established cognitive-behavioral treatments for migraine headache and adapted to fit an automated interactive platform available via an internet-enabled device. The program is divided into a series of treatment modules that will be delivered over 8 weeks. The online program combines treatment elements that are effective in preventing and managing migraine headache pain, including trigger management, stress management, relaxation techniques, cognitive reappraisal, and psychoeducation.
Group Type
EXPERIMENTAL
Health enSuite Headache
Intervention Type
BEHAVIORAL
The program consists of treatment modules delivered over 8 weeks. Modules include topics such as Headaches and Triggers, Relaxation, Breathing, Changing Thoughts, Imagery, Problem Solving, Nutrition, Sleep, Exercise, Medication, and more. Each module features sections like Goals, Getting Started, Let's Talk, and a Quiz, with Let's Practice in four modules. Intervention participants track headaches using a structured tracker to log impacts, daily events (e.g., exposure, strategies, medication), and notes. Control group participants track headaches only at baseline, two months, and five months post-randomization. Weekly reminders ("nudges") encourage app usage, with the same frequency for all users. Reports summarizing daily headache data are available to participants.
Waitlist Control
Participants allocated to the control group will not receive Health enSuite Migraine until after their participation in the trial has ended. During the trial, they will receive treatment as usual and will not be restricted from accessing other standard care services for migraine headache treatment.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Health enSuite Headache
The program consists of treatment modules delivered over 8 weeks. Modules include topics such as Headaches and Triggers, Relaxation, Breathing, Changing Thoughts, Imagery, Problem Solving, Nutrition, Sleep, Exercise, Medication, and more. Each module features sections like Goals, Getting Started, Let's Talk, and a Quiz, with Let's Practice in four modules. Intervention participants track headaches using a structured tracker to log impacts, daily events (e.g., exposure, strategies, medication), and notes. Control group participants track headaches only at baseline, two months, and five months post-randomization. Weekly reminders ("nudges") encourage app usage, with the same frequency for all users. Reports summarizing daily headache data are available to participants.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Fluent in English
* Age 18 to 50 years
* Regular access to an internet-connected device (e.g., smartphone, tablet, or computer)
* Scores 2 or more on the ID Migraine Screener
* Completes at least 50% of the daily entries when asked to use the migraine headache tracker for a 28-day period
* Experiences migraine headache on at least 4 days, but no more than 20 days, within the past month (based on diary data)
* Age 18 to 50 years
* Regular access to an internet-connected device (e.g., smartphone, tablet, or computer)
* Scores 2 or more on the ID Migraine Screener
* Completes at least 50% of the daily entries when asked to use the migraine headache tracker for a 28-day period
* Experiences migraine headache on at least 4 days, but no more than 20 days, within the past month (based on diary data)
Exclusion Criteria
* Diagnosis of psychosis and/or schizophrenia
* Physical or cognitive impairment that compromises ability to provide informed consent
* Pregnancy, planning pregnancy during the study, or currently breastfeeding
* Change in medications and/or dietary supplements (herbal supplements, minerals, vitamins) for migraine headache pain in the past month
Rationale for Eligibility Criteria:
Behavioural and/or psychosocial treatment is not recommended for migraine headache related to conditions such as psychosis, and/or schizophrenia. While behavioral and psychosocial treatments may offer some benefits for individuals with migraine headache related to psychosis and schizophrenia, there are also potential risks to consider. For example, CBT may involve exploring painful feelings and experiences, which could be distressing for individuals with psychosis. This could potentially exacerbate psychotic symptoms or lead to emotional distress. Additionally, some individuals with schizophrenia may have difficulty engaging in CBT due to cognitive impairments, such as difficulty concentrating or remembering information, or paranoia. Therefore, potential participants who have any of these conditions will be excluded from the study.
Pregnancy and breastfeeding result in hormonal changes that can increase migraine headache symptoms. Thus, guidelines for headache trials highly suggest excluding participants who are planning to be pregnant, currently pregnant or are nursing their infants.
The initiation of other treatments for migraine headache at the same time as Health enSuite Migraine could jeopardize the interpretation of the trial results. They are permitted to continue using any pre-existing treatments (medications, dietary supplements, vitamins). If participants are taking any medications/ and or dietary supplements, they must have been taking them for at least one month to be eligible for enrollment in the trial. Participants are asked at the end of the trial if they have started any new medication while using Health enSuite Migraine; if the new medication taken is recognized to have impacted the results, the participant's data will be removed for data analysis.
The age range of 18-50 years was chosen to align with the typical demographic most affected by migraine headache and to ensure the app's design and content are appropriate for its intended users. Research indicates that migraine headaches are most prevalent in this age group, with peak incidence occurring during early adulthood and middle age. Additionally, individuals outside this range, such as adolescents or older adults, may have distinct physiological, psychological, and treatment needs that differ from those of the target demographic.
For example, older adults often experience migraine headache differently due to age-related comorbidities or medication interactions, which may require specialized interventions beyond the scope of this study or app. Similarly, the app's features and usability are tailored to adults with regular access to technology and familiarity with app-based interventions.
The Health enSuite Migraine program being tested in this trial requires the use of an internet-connected device. Health enSuite Migraine can be accessed through the web browser on an electronic device with an internet connection. People who do not have regular access to an internet-connected device are unlikely to benefit from Health enSuite Migraine, and therefore they will be excluded.
Participants must have experienced migraine headache pain at least four days out of each month. This criterion is intended to ensure that all participants will experience at least some migraine headache symptoms throughout the study. Chronic daily migraine headaches are especially difficult to treat through psychosocial intervention alone, therefore participants who report migraine headache on more than 20 days per month will be excluded. Apart from the above mentioned 8 criteria points, study eligibility will be evaluated based on one month of daily migraine headache tracking completed at baseline to ensure the participant experiences a migraine headache between 4 to 20 days within the past month
* Physical or cognitive impairment that compromises ability to provide informed consent
* Pregnancy, planning pregnancy during the study, or currently breastfeeding
* Change in medications and/or dietary supplements (herbal supplements, minerals, vitamins) for migraine headache pain in the past month
Rationale for Eligibility Criteria:
Behavioural and/or psychosocial treatment is not recommended for migraine headache related to conditions such as psychosis, and/or schizophrenia. While behavioral and psychosocial treatments may offer some benefits for individuals with migraine headache related to psychosis and schizophrenia, there are also potential risks to consider. For example, CBT may involve exploring painful feelings and experiences, which could be distressing for individuals with psychosis. This could potentially exacerbate psychotic symptoms or lead to emotional distress. Additionally, some individuals with schizophrenia may have difficulty engaging in CBT due to cognitive impairments, such as difficulty concentrating or remembering information, or paranoia. Therefore, potential participants who have any of these conditions will be excluded from the study.
Pregnancy and breastfeeding result in hormonal changes that can increase migraine headache symptoms. Thus, guidelines for headache trials highly suggest excluding participants who are planning to be pregnant, currently pregnant or are nursing their infants.
The initiation of other treatments for migraine headache at the same time as Health enSuite Migraine could jeopardize the interpretation of the trial results. They are permitted to continue using any pre-existing treatments (medications, dietary supplements, vitamins). If participants are taking any medications/ and or dietary supplements, they must have been taking them for at least one month to be eligible for enrollment in the trial. Participants are asked at the end of the trial if they have started any new medication while using Health enSuite Migraine; if the new medication taken is recognized to have impacted the results, the participant's data will be removed for data analysis.
The age range of 18-50 years was chosen to align with the typical demographic most affected by migraine headache and to ensure the app's design and content are appropriate for its intended users. Research indicates that migraine headaches are most prevalent in this age group, with peak incidence occurring during early adulthood and middle age. Additionally, individuals outside this range, such as adolescents or older adults, may have distinct physiological, psychological, and treatment needs that differ from those of the target demographic.
For example, older adults often experience migraine headache differently due to age-related comorbidities or medication interactions, which may require specialized interventions beyond the scope of this study or app. Similarly, the app's features and usability are tailored to adults with regular access to technology and familiarity with app-based interventions.
The Health enSuite Migraine program being tested in this trial requires the use of an internet-connected device. Health enSuite Migraine can be accessed through the web browser on an electronic device with an internet connection. People who do not have regular access to an internet-connected device are unlikely to benefit from Health enSuite Migraine, and therefore they will be excluded.
Participants must have experienced migraine headache pain at least four days out of each month. This criterion is intended to ensure that all participants will experience at least some migraine headache symptoms throughout the study. Chronic daily migraine headaches are especially difficult to treat through psychosocial intervention alone, therefore participants who report migraine headache on more than 20 days per month will be excluded. Apart from the above mentioned 8 criteria points, study eligibility will be evaluated based on one month of daily migraine headache tracking completed at baseline to ensure the participant experiences a migraine headache between 4 to 20 days within the past month
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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IWK Health Centre
OTHER
Sponsor Role
lead
Responsible Party
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Patrick J. McGrath
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Patrick Patrick
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Central Contacts
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References
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Reference Type
BACKGROUND
Other Identifiers
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1018439
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1031367
Identifier Type: -
Identifier Source: org_study_id
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ENROLLING_BY_INVITATION
NA
Mi-Helper Transnasal Cooling for Acute Treatment of Migraine
NCT06051604
COMPLETED
NA
Introvision for Migraine and Headaches
NCT03507400
COMPLETED
NA
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
NCT06077812
COMPLETED
NA
Mind Body Balance for Pediatric Migraine
NCT04715685
RECRUITING
NA
ACT for High Frequency Migraine; A Virtual Mindfulness Intervention
NCT05003362
COMPLETED
NA
Study to Assess Function and Satisfaction of Oral Ubrogepant in Adult Participants After Multiple Migraine Attacks In Canada
NCT06692881
RECRUITING
Oxygenation and Perfusion in Patients With Acute Migraine Attacks
NCT03536936
COMPLETED
Cooling to Alleviate Migraine #3
NCT06874361
ACTIVE_NOT_RECRUITING
NA
Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD - a Pilot Study
NCT07292090
NOT_YET_RECRUITING
NA
A Study of Wearable Devices to Predict Migraines
NCT05755945
ENROLLING_BY_INVITATION
NA
PArtial REbreathing for Migraine With Aura 1
NCT05546385
TERMINATED
NA
The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study
NCT05556564
COMPLETED
Patient Reported Outcomes in Patients With Chronic Migraine Treated With BOTOX®
NCT02502123
COMPLETED
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
NCT05028569
TERMINATED
PHASE3
My Healthy Diary - An Electronic Diary for Remote Migraine Monitoring
NCT04828941
UNKNOWN
NA