Bronx MBCT-Migraine (BMBCT-M)
2020年9月17日 更新者:Elizabeth Seng、Albert Einstein College of Medicine
Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine.
調査の概要
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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New York
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Bronx、New York、アメリカ、10461
- Yeshiva University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- ICHD-3 beta headache diagnosis of migraine,
- self-reported and diary-confirmed 4-20 headache days per month
- aged 18-65
- ability to read English
- capacity to consent.
Exclusion Criteria:
- no ICHD-3 beta headache diagnosis of migraine
- fewer than 4 or greater than 20 headache days per month
- under 18 or over 65
- inability to read English
- lacking the capacity to consent
- utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
- severe psychiatric illness that would interfere with participation in the treatment
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:MBCT for Migraine
In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn).
Participants will attend weekly 75-90 minute individual sessions for eight weeks.
At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain).
Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc).
Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.
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8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
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介入なし:Wait List/Treatment as Usual
Patients will continue with standard care.
Patients will be offered MBCT after the primary endpoint.
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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 |
|---|---|---|
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Proportion of People With "Severe" Scores on the Migraine Disability Assessment
時間枠:Change from Month 1 to Month 4
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The MIDAS is a 5-item, self-report instrument that assesses the number of days in the past three months participants experienced partially or fully reduced functioning in a variety of contexts (work, school, social).
MIDAS scores are totaled and interpreted in the following grades: 0-5 = Grade I (Little or no disability); 6-10 = Grade II (Mild disability); 11-20 = Grade III (Moderate disability); 21+ = Grade IV (Severe disability).
Scores were dichotomized at "Not Severe" (Grades I, II, and III) and "Severe "(Grade IV).
The outcome was the proportion of participants who reported "Severe Disability."
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Change from Month 1 to Month 4
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Headache-Related Disability Index
時間枠:Change from Month 1 to Month 4
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25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities.
Total scores range from 0-100, with higher scores indicating higher levels of disability.
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Change from Month 1 to Month 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache Days (Over Course of 1 Month)
時間枠:Change from Month 1 to Month 4
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Number of headache days/month for the month prior to treatment, and the month after treatment
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Change from Month 1 to Month 4
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Average Headache Severity for Headache Days Recorded Over 30 Days
時間枠:Change from Month 1 to Month 4
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Headache Severity was recorded for every headache day on a scale of 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.
Average headache severity was averaged across all headache days for each month.
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Change from Month 1 to Month 4
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The Pain Catastrophizing Scale
時間枠:Change from Month 1 to Month 4
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13-item self-report measure that conveys a participant's level of pain-related, catastrophic thinking during painful experiences.
Total scores range from 0-52, with higher scores indicating higher levels of catastrophizing.
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Change from Month 1 to Month 4
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Chronic Pain Acceptance Questionnaire
時間枠:Change from Month 1 to Month 4
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20-item, self-report measure of pain-related acceptance.
Total scores range from 0-156 with higher scores indicating higher pain acceptance.
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Change from Month 1 to Month 4
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Five Facet Mindfulness Questionnaire
時間枠:Change from Month 1 to Month 4
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39-item self-report instrument assessing mindfulness.
Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.
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Change from Month 1 to Month 4
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Headache Specific Locus of Control
時間枠:Change from Month 1 to Month 4
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33-item measure designed to assess the extent to which individuals with recurrent headaches expect that the occurrence, worsening, and improvement of their headaches are influenced primarily by their own behavior, by chance or fate, or by the actions of medical professionals.
Total scores range from 33-165, with higher scores indicating more external (vs.
internal) locus of control.
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Change from Month 1 to Month 4
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Headache Management Self-efficacy Scale
時間枠:Change from Month 1 to Month 4
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25-item self-report scale designed to capture the confidence a patient believes they have in their own abilities to prevent headache episodes and manage their pain.
Total scores range from 25-175, with higher scores indicating higher levels of self-efficacy
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Change from Month 1 to Month 4
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NIH PROMIS Depression Short Form
時間枠:Change from Month 1 to Month 4
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8-item self-report measure that assesses emotional distress in the past week focusing on negative mood and negative self-views.
Scores are normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of depressive symptoms.
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Change from Month 1 to Month 4
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NIH PROMIS Anxiety Short Form
時間枠:Change from Month 1 to Month 4
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8-item self-report measure that assesses emotional distress in the past week focusing on fear, worry and hyper-arousal.
Scores were normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of anxious symptoms.
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Change from Month 1 to Month 4
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Average Monthly Migraine Disability Index
時間枠:Change from Month 1 through Month 4
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A daily 4-item measure of migraine related disability.
Scores range from 0-10, with higher scores indicating higher levels of disability.
Scores are averaged across all headache days recorded each month.
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Change from Month 1 through Month 4
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協力者と研究者
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年7月1日
一次修了 (実際)
2018年10月1日
研究の完了 (実際)
2019年2月1日
試験登録日
最初に提出
2015年5月8日
QC基準を満たした最初の提出物
2015年5月11日
最初の投稿 (見積もり)
2015年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月12日
QC基準を満たした最後の更新が送信されました
2020年9月17日
最終確認日
2020年9月1日
詳しくは
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