App-Based Migraine Treatment: The Health enSuite Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorIWK Health Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Health enSuite Headache
BehavioralThe 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.
Treatment groups
415 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline assessment, 2 months post randomization, 5 months post randomizationSecondary outcomes
1
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.
Time frame
Baseline assessment, 2 months post randomization, 5 months post randomization2
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)
Time frame
Baseline assessment, 2 months post randomization, 5 months post randomization3
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+)
Time frame
Baseline assessment, 2 months post randomization, 5 months post randomization4
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)
Time frame
Baseline assessment, 2 months post randomization, 5 months post randomizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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