App-Based Migraine Treatment: The Health enSuite Study

Официальное название

Evaluating an App-Based Treatment for Migraine: The Health enSuite Migraine Study

Обзор

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.

Подробное описание

Headaches are highly prevalent among Canadians and many people visit their primary care provider due to headache symptoms. Headaches can be classified based on frequency (acute, episodic, chronic) and symptom presentation (migraine headache, 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. Up to 70% of individuals experience tension headaches, and 8.3% of Canadians are affected by migraine headache.

Headache symptoms can last a few hours to several days and are debilitating as they cause significant pain and distress. 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).

People who seek medical attention from their primary care provider for their headache pain often have difficulty receiving adequate treatment. 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 .

Among headache disorders, migraine headaches are particularly debilitating due to their neurological basis, severity, and high burden on daily functioning. Unlike tension-type headaches, migraine headaches involve additional symptoms such as nausea, photophobia, and phonophobia, leading to greater disability. Given this significant impact, our study focuses specifically on developing a digital Cognitive Behavioral Therapy (CBT) intervention for migraine headache sufferers.

The National Canadian Migraine Strategy has recommended self-management patient interventions and patient education to learn skills to manage their symptoms in partnership with their healthcare providers. They have also advocated for the use of non-pharmacological therapies like stress management, skills to avoid triggers causing migraine headache, relaxation therapies, and self-monitoring for the management of migraine headache as part of their chronic disease management program for migraine headache. Although many medications can reduce pain due to migraine headache, their frequent use has associated side effects, and the prolonged use or overuse of medications can also cause migraine headache. Thus, an overreliance on pharmacological treatments and a lack of attention to lifestyle and psychosocial factors contributing to migraine headache symptoms can create sub-optimal outcomes for patients. Therefore, our goal is to develop a CBT program for migraine headache that can be delivered through an internet-connected phone, tablet, or computer and provide effective treatment to a wide range of patients with migraine headache. Health enSuite is a suite of applications designed by our research team at the Centre of Research in Family Health at IWK Health. Health enSuite will be utilized by patients suffering from 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 people suffering from migraine headache. 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.

Вмешательства

• Поведенческое Health enSuite Headache
  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), a

Первичные конечные точки

• Change in Migraine Headache Frequency [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]

Вторичные конечные точки (6)

• Responder Rate for Migraine Headache [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]
• Change in Maximum Migraine Headache Intensity [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]
• Change in Migraine-Related Functional Impairment (MIDAS) [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]
• Change in Depression Symptoms (PHQ-9) [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]
• Changes in Daily Factors Related to Migraine Episodes [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]
• Changes from baseline in daily factors [Срок оценки: Baseline assessment, 2 months post randomization, 5 months post randomization]

Критерии участия

Inclusion Criteria (for study entry):

• 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

Inclusion Criteria (for enrollment):

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Becker WJ. Weather and migraine: can so many patients be wrong? Cephalalgia. 2011 Mar;31(4):387-90. doi: 10.1177/0333102410385583. Epub 2010 Dec 16. No abstract available. PMID 21163817
• Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001 Oct;41(9):854-61. PMID 11703471
• World Health Organization. (2016). World Health Statistics 2016 [OP]: Monitoring Health for the Sustainable Development Goals (SDGs). World Health Organization.
• Ramage-Morin PL, Gilmour H. Prevalence of migraine in the Canadian household population. Health Rep. 2014 Jun;25(6):10-6. PMID 24941316
• Becker WJ. Cervicogenic headache: evidence that the neck is a pain generator. Headache. 2010 Apr;50(4):699-705. doi: 10.1111/j.1526-4610.2010.01648.x. PMID 20456156
• Lipton RB, Bigal ME, Kolodner K, Stewart WF, Liberman JN, Steiner TJ. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia. 2003 Jul;23(6):429-40. doi: 10.1046/j.1468-2982.2003.00543.x. PMID 12807522
• Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: A review. Cephalalgia. 2016 Jan;36(1):67-91. doi: 10.1177/0333102415580099. Epub 2015 Apr 17. PMID 25888584
• Lipton RB, Hamelsky SW, Kolodner KB, Steiner TJ, Stewart WF. Migraine, quality of life, and depression: a population-based case-control study. Neurology. 2000 Sep 12;55(5):629-35. doi: 10.1212/wnl.55.5.629. PMID 10980724

Идентификаторы

NCT: NCT06797076 · 1031367 · 1018439

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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