Health enSuite Headache: App-based Treatment for Adult Migraine

Launched by IWK HEALTH CENTRE · Jan 22, 2025

Keywords

ClinConnect Summary

The Health enSuite Headache trial is studying a new way to help adults manage migraine headaches using a mobile app. This app is designed to provide patients with effective techniques to prevent and relieve migraine pain, including ways to identify headache triggers, manage stress, and learn relaxation methods. The goal is to make these helpful tools easily accessible for patients through their family doctors in Canada.

To be eligible for this trial, participants need to be between 18 and 50 years old and have a history of migraines for at least a year. They should also speak English fluently, have regular access to the internet, and score a certain level of headache-related disability on a specific assessment. During the trial, participants will use a headache tracker for a month and engage with the app to track their symptoms and learn new coping strategies. This study aims to improve how people manage their migraines and enhance their quality of life.

Gender

ALL

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.