ヘルスエンスイート頭痛：成体片頭痛のアプリベースの治療
慢性頭痛のためのアプリベースの治療法の評価：Health Ensuite片頭痛研究
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3K 6R8
- IWK Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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. |
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介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Migraine Headache Frequency
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Responder Rate for Migraine Headache
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
|
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. |
Baseline assessment, 2 months post randomization, 5 months post randomization
|
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Change in Maximum Migraine Headache Intensity
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
|
Maximum headache intensity will be self-reported using the migraine headache tracker. Unit of Measure: Intensity score (0-10 scale) |
Baseline assessment, 2 months post randomization, 5 months post randomization
|
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Change in Migraine-Related Functional Impairment (MIDAS)
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
|
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+) |
Baseline assessment, 2 months post randomization, 5 months post randomization
|
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Change in Depression Symptoms (PHQ-9)
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
|
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) |
Baseline assessment, 2 months post randomization, 5 months post randomization
|
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Changes in Daily Factors Related to Migraine Episodes
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
|
Exploratory assessment of daily self-reported factors (sleep, mood, emotional state, environmental exposures, dietary intake, coping strategies, and medication use) and their association with migraine episodes, as reported in the optional components of the migraine headache tracker. Unit of Measure: Self-reported diary entries (descriptive/exploratory; no single standardized unit) |
Baseline assessment, 2 months post randomization, 5 months post randomization
|
|
Changes from baseline in daily factors
時間枠：Baseline assessment, 2 months post randomization, 5 months post randomization
|
such as sleep, mood, emotional state, environmental exposures, dietary intake, coping strategies, and medication use, and their potential associations with migraine episodes, as self-reported in the optional components of the migraine headache tracker. |
Baseline assessment, 2 months post randomization, 5 months post randomization
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Patrick Patrick、IWK Health Centre
出版物と役立つリンク
一般刊行物
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- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
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- 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.
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- Dodick DW, Loder EW, Manack Adams A, Buse DC, Fanning KM, Reed ML, Lipton RB. Assessing Barriers to Chronic Migraine Consultation, Diagnosis, and Treatment: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2016 May;56(5):821-834. doi: 10.1111/head.12774. Epub 2016 May 3.
- Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015 Aug;61(8):670-9.
- Diener HC, Dodick D, Evers S, Holle D, Jensen RH, Lipton RB, Porreca F, Silberstein S, Schwedt T. Pathophysiology, prevention, and treatment of medication overuse headache. Lancet Neurol. 2019 Sep;18(9):891-902. doi: 10.1016/S1474-4422(19)30146-2. Epub 2019 Jun 4.
- Penzien DB, Andrasik F, Freidenberg BM, Houle TT, Lake AE 3rd, Lipchik GL, Holroyd KA, Lipton RB, McCrory DC, Nash JM, Nicholson RA, Powers SW, Rains JC, Wittrock DA; American Headache Society Behavioral Clinical Trials Workgroup. Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society Behavioral Clinical Trials Workgroup. Headache. 2005 May;45 Suppl 2:S110-32. doi: 10.1111/j.1526-4610.2005.4502004.x.
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- Kelman L. Migraine changes with age: IMPACT on migraine classification. Headache. 2006 Jul-Aug;46(7):1161-71. doi: 10.1111/j.1526-4610.2006.00444.x.
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1031367
- 1018439 (その他の助成金/資金番号：CIHR)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. 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. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.
IPD 共有時間枠
From study closure to five years post publication.
IPD 共有アクセス基準
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.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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