App-Based Migraine Treatment: The Health enSuite Study

NCT06797076 | Not Yet Recruiting

• 2 other identifiers: 10313671018439
• Study Type: interventional
• Target: 415
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Migraine; Migraine With Aura; Migraine Without Aura

Keywords

Headache; Migraine; Cognitive Behavioral Therapy

Outcome Measures

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

  Baseline assessment, 2 months post randomization, 5 months post randomization

Secondary Outcomes (6)

• Responder Rate for Migraine Headache

  Baseline assessment, 2 months post randomization, 5 months post randomization

• Change in Maximum Migraine Headache Intensity

  Baseline assessment, 2 months post randomization, 5 months post randomization

• Change in Migraine-Related Functional Impairment (MIDAS)

  Baseline assessment, 2 months post randomization, 5 months post randomization

• Change in Depression Symptoms (PHQ-9)

  Baseline assessment, 2 months post randomization, 5 months post randomization

• Changes in Daily Factors Related to Migraine Episodes

  Baseline assessment, 2 months post randomization, 5 months post randomization

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Health enSuite Headache

Waitlist Control

NO INTERVENTION

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.

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Completes at least 50% of the daily entries when asked to use the migraine headache tracker for a 28-day period
• Experiences migraine headache on at least 4 days, but no more than 20 days, within the past month (based on diary data)

You may not qualify if:

• 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
• Rationale for Eligibility Criteria:
• Behavioural and/or psychosocial treatment is not recommended for migraine headache related to conditions such as psychosis, and/or schizophrenia. While behavioral and psychosocial treatments may offer some benefits for individuals with migraine headache related to psychosis and schizophrenia, there are also potential risks to consider. For example, CBT may involve exploring painful feelings and experiences, which could be distressing for individuals with psychosis. This could potentially exacerbate psychotic symptoms or lead to emotional distress. Additionally, some individuals with schizophrenia may have difficulty engaging in CBT due to cognitive impairments, such as difficulty concentrating or remembering information, or paranoia. Therefore, potential participants who have any of these conditions will be excluded from the study.
• Pregnancy and breastfeeding result in hormonal changes that can increase migraine headache symptoms. Thus, guidelines for headache trials highly suggest excluding participants who are planning to be pregnant, currently pregnant or are nursing their infants.
• The initiation of other treatments for migraine headache at the same time as Health enSuite Migraine could jeopardize the interpretation of the trial results. They are permitted to continue using any pre-existing treatments (medications, dietary supplements, vitamins). If participants are taking any medications/ and or dietary supplements, they must have been taking them for at least one month to be eligible for enrollment in the trial. Participants are asked at the end of the trial if they have started any new medication while using Health enSuite Migraine; if the new medication taken is recognized to have impacted the results, the participant's data will be removed for data analysis.
• The age range of 18-50 years was chosen to align with the typical demographic most affected by migraine headache and to ensure the app's design and content are appropriate for its intended users. Research indicates that migraine headaches are most prevalent in this age group, with peak incidence occurring during early adulthood and middle age. Additionally, individuals outside this range, such as adolescents or older adults, may have distinct physiological, psychological, and treatment needs that differ from those of the target demographic.
• For example, older adults often experience migraine headache differently due to age-related comorbidities or medication interactions, which may require specialized interventions beyond the scope of this study or app. Similarly, the app's features and usability are tailored to adults with regular access to technology and familiarity with app-based interventions.
• The Health enSuite Migraine program being tested in this trial requires the use of an internet-connected device. Health enSuite Migraine can be accessed through the web browser on an electronic device with an internet connection. People who do not have regular access to an internet-connected device are unlikely to benefit from Health enSuite Migraine, and therefore they will be excluded.
• Participants must have experienced migraine headache pain at least four days out of each month. This criterion is intended to ensure that all participants will experience at least some migraine headache symptoms throughout the study. Chronic daily migraine headaches are especially difficult to treat through psychosocial intervention alone, therefore participants who report migraine headache on more than 20 days per month will be excluded. Apart from the above mentioned 8 criteria points, study eligibility will be evaluated based on one month of daily migraine headache tracking completed at baseline to ensure the participant experiences a migraine headache between 4 to 20 days within the past month

Sponsors & Collaborators

• IWK Health Centre: lead

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MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Patrick

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaisheen Kour Reen, MCS

CONTACT

1-877-341-8309; TeamHealthEnSuite@iwk.nshealth.ca

Maryam Akbari

CONTACT

Maryam.Akbari@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This project consists of a pragmatic randomized controlled trial (RCT). The Consolidated Standards of Reporting Trials (CONSORT) recommendations (http://www.consort-statement.org/) will guide the methodology. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in both groups will complete self-assessments including key outcome measures at baseline before starting the study, at two months post-randomization, and again at six months post-randomization. Participants in the intervention group will receive the full Health enSuite Migraine program described below immediately after being randomized to this group. Participants in the waitlist control group will be waitlisted during the study. After their participation in the study has ended, participants in the waitlist control group will be given access to the full Health enSuite Migraine program for two months.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: January 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: From study closure to five years post publication.
• Access Criteria: During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study.