Clinical trial NCT06797076: Health enSuite Headache: App-based Treatment for Adult Migraine
Official title: Evaluating an App-Based Treatment for Chronic Headaches: The Health enSuite Migraine Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Keywords: Headache
Migraine
Cognitive Behavioral Therapy
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project consists of a pragmatic randomized controlled trial. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a wait-list control group. Participants in both groups will complete self-assessments, including key outcome measures, at baseline, and 3- and 6-months post-randomization. Participants in the intervention group will receive the full Health enSuite Headache program immediately after being randomized to this group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache frequency
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
Secondary outcomes:
measure: Responder Rate for Headaches
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change from baseline in maximum headache Intensity
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change from baseline in headache related functional impairment
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change from baseline in Depression symptoms
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change from baseline in Anxiety symptoms
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Patrick Patrick
role: PRINCIPAL_INVESTIGATOR
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