MigraineNCT06797076
App-Based Migraine Treatment: The Health enSuite Study
A study testing Health enSuite Headache in people with Migraine and Migraine With Aura, run by IWK Health Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Health enSuite Headache
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2026to 2 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating an App-Based Treatment for Migraine: The Health enSuite Migraine Study
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.
Read the detailed description
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.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Being tested
- Health enSuite Headache
- Keywords
- Headache, Migraine, Cognitive Behavioral Therapy
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health enSuite HeadacheBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Health enSuite Headache |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Migraine Headache Frequency
Migraine headache frequency will be tracked using the electronic migraine headache tracker within the Health enSuite Migraine app. The outcome is the change from baseline in the number of migraine headache days.
Unit of Measure: Number of migraine headache days per month
Measured: Baseline assessment, 2 months post randomization, 5 months post randomization
Secondary outcomes (6)
Responder Rate for Migraine Headache
Percentage of participants achieving ≥30% reduction in migraine headache days from baseline, measured via the migraine headache tracker.
Unit of Measure: % of participants with ≥30% reduction in headache days.
Measured: Baseline assessment, 2 months post randomization, 5 months post randomization
Change in Maximum Migraine Headache Intensity
Maximum headache intensity will be self-reported using the migraine headache tracker.
Unit of Measure: Intensity score (0-10 scale)
Measured: Baseline assessment, 2 months post randomization, 5 months post randomization
Change in Migraine-Related Functional Impairment (MIDAS)
The Migraine Disability Assessment (MIDAS) questionnaire will be used to measure functional impairment due to migraine. The outcome is the change in MIDAS total score.
Unit of Measure: MIDAS total score (0-21+)
Measured: Baseline assessment, 2 months post randomization, 5 months post randomization
Change in Depression Symptoms (PHQ-9)
Depression symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). The outcome is the change in PHQ-9 total score.
Unit of Measure: PHQ-9 total score (0-27)
Measured: Baseline assessment, 2 months post randomization, 5 months post randomization
Changes in Daily Factors Related to Migraine Episodes
Exploratory assessment of daily self-reported factors (sleep, mood, emotional state, environmental exposures, dietary intake, coping strategies, and medication use) and their association with migraine episodes, as reported in the optional components of the migraine headache tracker.
Unit of Measure: Self-reported diary entries (descriptive/exploratory; no single standardized unit)
Measured: Baseline assessment, 2 months post randomization, 5 months post randomization
Changes from baseline in daily factors
such as sleep, mood, emotional state, environmental exposures, dietary intake, coping strategies, and medication use, and their potential associations with migraine episodes, as self-reported in the optional components of the migraine headache tracker.
Measured: Baseline assessment, 2 months post randomization, 5 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 posted28 Jan 2025
- Study start15 Feb 2026
- Primary completion2 Mar 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick J. McGrath, IWK Health Centre
- Investigators
- Patrick Patrick, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797076
- Sponsor's protocol ID
- 1031367
- Other IDs
- 1018439
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.
Publications
Becker WJ. Weather and migraine: can so many patients be wrong? Cephalalgia. 2011 Mar;31(4):387-90. doi: 10.1177/0333102410385583. Epub 2010 Dec 16. No abstract available.
PubMed 21163817Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001 Oct;41(9):854-61.
PubMed 11703471World Health Organization. (2016). World Health Statistics 2016 [OP]: Monitoring Health for the Sustainable Development Goals (SDGs). World Health Organization.
Ramage-Morin PL, Gilmour H. Prevalence of migraine in the Canadian household population. Health Rep. 2014 Jun;25(6):10-6.
PubMed 24941316Becker WJ. Cervicogenic headache: evidence that the neck is a pain generator. Headache. 2010 Apr;50(4):699-705. doi: 10.1111/j.1526-4610.2010.01648.x.
PubMed 20456156Lipton RB, Bigal ME, Kolodner K, Stewart WF, Liberman JN, Steiner TJ. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia. 2003 Jul;23(6):429-40. doi: 10.1046/j.1468-2982.2003.00543.x.
PubMed 12807522Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: A review. Cephalalgia. 2016 Jan;36(1):67-91. doi: 10.1177/0333102415580099. Epub 2015 Apr 17.
PubMed 25888584Lipton RB, Hamelsky SW, Kolodner KB, Steiner TJ, Stewart WF. Migraine, quality of life, and depression: a population-based case-control study. Neurology. 2000 Sep 12;55(5):629-35. doi: 10.1212/wnl.55.5.629.
PubMed 10980724Linde M, Jonsson P, Hedenrud T. Influence of disease features on adherence to prophylactic migraine medication. Acta Neurol Scand. 2008 Dec;118(6):367-72. doi: 10.1111/j.1600-0404.2008.01042.x. Epub 2008 May 27.
PubMed 18513346Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
PubMed 17261680Dodick DW, Loder EW, Manack Adams A, Buse DC, Fanning KM, Reed ML, Lipton RB. Assessing Barriers to Chronic Migraine Consultation, Diagnosis, and Treatment: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2016 May;56(5):821-834. doi: 10.1111/head.12774. Epub 2016 May 3.
PubMed 27143127Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015 Aug;61(8):670-9.
PubMed 26273080Diener HC, Dodick D, Evers S, Holle D, Jensen RH, Lipton RB, Porreca F, Silberstein S, Schwedt T. Pathophysiology, prevention, and treatment of medication overuse headache. Lancet Neurol. 2019 Sep;18(9):891-902. doi: 10.1016/S1474-4422(19)30146-2. Epub 2019 Jun 4.
PubMed 31174999Penzien DB, Andrasik F, Freidenberg BM, Houle TT, Lake AE 3rd, Lipchik GL, Holroyd KA, Lipton RB, McCrory DC, Nash JM, Nicholson RA, Powers SW, Rains JC, Wittrock DA; American Headache Society Behavioral Clinical Trials Workgroup. Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society Behavioral Clinical Trials Workgroup. Headache. 2005 May;45 Suppl 2:S110-32. doi: 10.1111/j.1526-4610.2005.4502004.x.
PubMed 15921503Whyte CA, Tepper SJ. Adverse effects of medications commonly used in the treatment of migraine. Expert Rev Neurother. 2009 Sep;9(9):1379-91. doi: 10.1586/ern.09.47.
PubMed 19769452
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an App-Based Treatment for Migraine: The Health enSuite Migraine Study
- ClinicalTrials.gov ID
- NCT06797076
- Acronym / sponsor ID
- 1031367
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Keywords
- Headache, Migraine, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 28 Jan 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health enSuite HeadacheHealth 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- 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.
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 |
|---|---|---|
| Health enSuite HeadacheThe 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. | Behavioural | Intervention |
Primary outcome
Change in Migraine Headache Frequency
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Migraine headache frequency will be tracked using the electronic migraine headache tracker within the Health enSuite Migraine app. The outcome is the change from baseline in the number of migraine headache days. Unit of Measure: Number of migraine headache days per month
6 secondary outcomes
Responder Rate for Migraine Headache
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Change in Maximum Migraine Headache Intensity
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Change in Migraine-Related Functional Impairment (MIDAS)
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Change in Depression Symptoms (PHQ-9)
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Changes in Daily Factors Related to Migraine Episodes
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Changes from baseline in daily factors
Time frame: Baseline assessment, 2 months post randomization, 5 months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 21163817Becker WJ. Weather and migraine: can so many patients be wrong? Cephalalgia. 2011 Mar;31(4):387-90. doi: 10.1177/0333102410385583. Epub 2010 Dec 16. No abstract available.
- Background: PubMed 11703471Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001 Oct;41(9):854-61.
- BackgroundWorld Health Organization. (2016). World Health Statistics 2016 [OP]: Monitoring Health for the Sustainable Development Goals (SDGs). World Health Organization.
- Background: PubMed 24941316Ramage-Morin PL, Gilmour H. Prevalence of migraine in the Canadian household population. Health Rep. 2014 Jun;25(6):10-6.
- Background: PubMed 20456156Becker WJ. Cervicogenic headache: evidence that the neck is a pain generator. Headache. 2010 Apr;50(4):699-705. doi: 10.1111/j.1526-4610.2010.01648.x.
- Background: PubMed 12807522Lipton RB, Bigal ME, Kolodner K, Stewart WF, Liberman JN, Steiner TJ. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia. 2003 Jul;23(6):429-40. doi: 10.1046/j.1468-2982.2003.00543.x.
- Background: PubMed 25888584Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: A review. Cephalalgia. 2016 Jan;36(1):67-91. doi: 10.1177/0333102415580099. Epub 2015 Apr 17.
- Background: PubMed 10980724Lipton RB, Hamelsky SW, Kolodner KB, Steiner TJ, Stewart WF. Migraine, quality of life, and depression: a population-based case-control study. Neurology. 2000 Sep 12;55(5):629-35. doi: 10.1212/wnl.55.5.629.
- Background: PubMed 18513346Linde M, Jonsson P, Hedenrud T. Influence of disease features on adherence to prophylactic migraine medication. Acta Neurol Scand. 2008 Dec;118(6):367-72. doi: 10.1111/j.1600-0404.2008.01042.x. Epub 2008 May 27.
- Background: PubMed 17261680Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
- Background: PubMed 27143127Dodick DW, Loder EW, Manack Adams A, Buse DC, Fanning KM, Reed ML, Lipton RB. Assessing Barriers to Chronic Migraine Consultation, Diagnosis, and Treatment: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2016 May;56(5):821-834. doi: 10.1111/head.12774. Epub 2016 May 3.
- Background: PubMed 26273080Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015 Aug;61(8):670-9.
- Individual participant dataSharing planned: Yes. De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence
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.
Patrick Patrick 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 Health enSuite Headache in people with Migraine and Migraine With Aura, 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Migraine Headache Frequency (time frame: Baseline assessment, 2 months post randomization, 5 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06797076, which also lists 39 linked publications.
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 5 Nov 2026.