App-Based Migraine Treatment: The Health enSuite Study

Sponsor
IWK Health Centre
Study ID
NCT06797076
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Health enSuite Headache — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Jan 28, 2025
Start date
Feb 15, 2026
Status verified
Aug 2025
Primary completion
Jan 2, 2027
Completion
Jun 2, 2027

Study Design

Enrollment
415 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    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.
  • No Intervention: Waitlist Control
    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.

Primary Outcome Measure

Change in Migraine Headache Frequency [ Time Frame: Baseline assessment, 2 months post randomization, 5 months post randomization ]

Central Contacts

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