Health enSuite Headache: App-based Treatment for Adult Migraine

Not Applicable

Not yet recruiting

• Conditions: Migraine; Migraine With Aura; Migraine Without Aura

• Registration Number: NCT06797076
• Lead Sponsor: IWK Health Centre

Brief 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. Health enSuite will be utilized by Canadian family physicians targeting insomnia, anxiety, migraine headaches, and caregiver distress.Health enSuite Headache has been designed to make cognitive and behavioral techniques for managing migraine headaches 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 (17, 18, 19, 20).

Detailed Description

Headaches are highly prevalent among Canadians and many people visit their primary care provider due to headache symptoms (1,2). Headaches can be classified based on frequency (acute, episodic, chronic) and symptom presentation (migraine, 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 (3). Up to 70% of individuals experience tension headaches (3), and 8.3% of Canadians are affected by migraine headaches (4).

Headache symptoms can last a few hours to several days and are debilitating as they cause significant pain and distress (4,5). 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) (6,7).

People who seek medical attention from their primary care provider for their headache pain often have difficulty receiving adequate treatment (8, 9, 10, 11). 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 (12, 13, 14).

The National Canadian Migraine Strategy has recommended self-management patient interventions and patient education to learn skills to manage their headache symptoms in partnership with their healthcare providers (5). They have also advocated for the use of non-pharmacological therapies like stress management, skills to avoid triggers causing headaches, relaxation therapies, and self-monitoring for the management of migraine headaches as part of their chronic disease management program for migraine. Although many medications can reduce pain due to headaches or migraine, their frequent use has associated side effects (15), and the prolonged use or overuse of medications can also cause headaches (16). Thus, an overreliance on pharmacological treatments and a lack of attention to lifestyle and psychosocial factors contributing to headache symptoms can create sub-optimal outcomes for patients. Therefore, our goal is to develop a Cognitive Behavioral Therapy for headache diseases (CBT-HA) program that can be delivered through an internet-connected phone, tablet, or computer and provide effective treatment to a wide range of patients with migraine. Given that primary care physicians are the first source of assistance for individuals facing problems with migraine, internet-based CBT-HA has the potential to be a useful tool for primary care physicians to recommend to their patients.

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Study Start: 2025-06-02
• Primary Completion: 2026-06-02
• Study Completion: 2027-06-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. The participant has a history of migraine (with or without aura) for a minimum of 1 year before screening, according to the International Headache Society (IHS) Classification ICHD-3 (22), based on medical records.
2. The participant is fluent in English.
3. The participant does not have psychosis and/or schizophrenia.
4. The participant does not have a physical or cognitive impairment that compromises the ability to give informed consent.
5. The participant is not pregnant, planning to become pregnant during the study, or currently breastfeeding.
6. The participant has not changed their medications and/or dietary supplements (herbal supplements, minerals, and vitamins) for headache pain in the past month.
7. The participant is between 18 and 50 years old.
8. The participant has regular access to an internet-connected device (e.g., smartphone, tablet, or computer).
9. The participant scores six or more on the Migraine Disability Assessment (MIDAS) tool.

Inclusion Criteria for Enrollment:

1. The participant completes at least 50% of the daily entries when using the headache tracker for a 28-day period.
2. The participant has experienced headaches on at least four days but no more than 20 days within the past month (based on diary data).

Exclusion Criteria

1. Individuals experiencing headaches on more than 20 days per month.
2. Individuals diagnosed with psychosis and/or schizophrenia, as behavioral and psychosocial treatments are not recommended for these conditions.
3. Individuals who are pregnant, planning pregnancy, or breastfeeding, as hormonal changes can impact headache symptoms.
4. Individuals who have recently started new treatments for headaches, as this could impact study results. Participants must have been on any pre-existing treatments for at least one month before enrollment.
5. Individuals without regular access to an internet-connected device, as the Health enSuite Headache program requires online access.

Rationale for Eligibility Criteria:

1. The 18-50-year-old age range was chosen as migraines are most prevalent in this demographic. Additionally, older adults and adolescents may have distinct treatment needs that differ from the study's target population.
2. Headache frequency criteria (4-20 days per month) ensure that participants experience enough symptoms to benefit from the intervention while excluding those with chronic daily headaches, which may require more specialized care.
3. The requirement for a MIDAS score of six or more ensures that participants have a minimum level of migraine-related impairment to benefit from the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Headache frequency	Baseline assessment, 3 months post randomization, 6 months post randomization	In both groups, headache frequency will be tracked thrice using an electronic headache tracker within the Health enSuite Headache app. Our primary focus is to assess the difference in the change from baseline in the number of headache days between the groups at the two follow-up points.

Secondary Outcome Measures

Name	Time	Method
Responder Rate for Headaches	Baseline assessment, 3 months post randomization, 6 months post randomization	This would be done by comparing the percentage of participants achieving at least a 30% reduction in number of headache days from baseline at the two follow-up points between the two groups. In previous studies, a clinically significant reduction in headache frequency is considered to be 50% \[14\]. However, in this study, the investigators are using a 30% reduction as the threshold for significance. This outcome will be evaluated using the headache tracker.
Change from baseline in maximum headache Intensity	Baseline assessment, 3 months post randomization, 6 months post randomization	The investigators will compare the reduction in maximum headache intensity from baseline to the follow-up points between the two groups. Headache intensity will be evaluated using the headache tracker.
Change from baseline in headache related functional impairment	Baseline assessment, 3 months post randomization, 6 months post randomization	Migraine Disability Assessment tool (MIDAS) will be used to measure the extent to which headache is interfering with daily functioning (35). This questionnaire consists of five questions related to an individual's headache patterns during the past three months, but in our study, the investigators are going to take into consideration only the past month. It has been used frequently in primary care settings and has demonstrated high usability among primary care clinicians (2, 36, 37). The investigators will treat this variable as a continuous variable, with the outcome being the change in MIDAS score from baseline to post-randomization.
Change from baseline in Depression symptoms	Baseline assessment, 3 months post randomization, 6 months post randomization	The Patient Health Questionnaire (PHQ-9) will be used to measure comorbid symptoms of depression (26, 27). This has been widely used to screen individuals for depression in primary care (28, 29, 30) and as an outcome measure in treatment studies (31, 32). Scores equal to or above 10 indicate the presence of depression (26; 33). This assessment will be compared between the two groups from baseline and at the two follow-up points.
Change from baseline in Anxiety symptoms	Baseline assessment, 3 months post randomization, 6 months post randomization	The Generalized Anxiety Disorder questionnaire (GAD-7) will be used as a secondary measure of anxiety symptoms. It is a brief, seven-item questionnaire that was designed to screen for anxiety disorders in primary care settings (34) and has been widely used as an outcome measure in anxiety treatment studies (35). It measures the frequency of anxiety symptoms over the past 2 weeks and is assessed based on a four-point scale ranging from 0 ("Not at all sure") to 3 ("Nearly every day") (34). A cut-off score of 10 or higher indicates the presence of an anxiety disorder. This assessment will be compared between the two groups from baseline and at the two follow-up points.