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Набор скоро начнётся NCT07513662

Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain

Без фазы С лечением Migraine Migraine in Adolescence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BREATHE with Headache (BREATHE-HA), Enhanced Standard-of-Care: Headache Education.
Кому может быть актуально
Состояния в реестре: Migraine, Migraine in Adolescence. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine

Обзор

The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable: 1. Telehealth group mindfulness-based intervention 2. Telehealth group headache education

Подробное описание

Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by examining an MBI that was adapted specifically for adolescents with migraine. This a pilot randomized controlled trial is designed to test feasibility and acceptability in preparation for a future efficacy trial. Adolescents with migraine will be randomized to one of two 6-week telehealth group programs: a mindfulness-based intervention (BREATHE-Headache) or Enhanced Standard-of-Care (a headache education program). Participants (and their parent/guardian) will complete assessments at baseline, immediately post-intervention, and 12-week follow up.

Вмешательства

  • Поведенческое BREATHE with Headache (BREATHE-HA)
    BREATHE-HA is a 6-session group mindfulness-based intervention delivered via telehealth for adolescents with migraine. The intervention was adapted from an empirically-supported mindfulness-based intervention for adolescents (Learning to BREATHE; Broderick, 2021). Example activities include breath awareness, body scanning, mindful eating, loving-kindness practice, and mindful movement, as well as activities and discussion focused on improving distress tolerance and enhancing self-care, with exam
  • Поведенческое Enhanced Standard-of-Care: Headache Education
    Enhanced Standard-of-Care is a 6-session group headache education program delivered via telehealth. It will be derived from a manual with fidelity as an attention-matched control in a behavioral trial for pediatric migraine. Headache education will include didactics and discussion on headache symptoms, medication, lifestyle factors for pain management, communication with providers, education on mood/stress, and impact of headaches on school and family.

Первичные конечные точки

  • Recruitment Feasibility (Primary) [Срок оценки: 24 months]
Вторичные конечные точки (6)
  • Recruitment Feasibility (Secondary) [Срок оценки: 24 months]
  • Retention (Secondary) [Срок оценки: Post-intervention (1 week after final intervention session); 12-week follow-up]
  • Intervention Adherence (Secondary) [Срок оценки: 6 weeks]
  • Acceptability (Secondary) [Срок оценки: Post-intervention (1 week after final intervention session)]
  • Protocol Feasibility (Secondary) [Срок оценки: Baseline, post-intervention (1 week after final intervention session), 12-week follow-up]
  • Intervention Fidelity (Secondary) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Age 12 to 17 years old
  • Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
  • Patient report of at least 6 headache days per month
  • At least mild headache-related disability, as assessed by PedMIDAS score > 10
  • Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment
  • Adolescent participant fluent in English for the intervention content

Критерии исключения

  • Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months
  • Current psychiatric crisis (e.g., active suicidal ideation)
  • Cognitive impairments or developmental delays that interfere with their ability to participate in the study
  • Inability to provide consent/assent

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Children's Hospital Colorado — Aurora

Публикации

  • Broderick, P. C. (2021). Learning to breathe: A mindfulness curriculum for adolescents to cultivate emotion regulation, attention, and performance. New Harbinger Publications.

Идентификаторы

NCT: NCT07513662 · 25-1999 · 1K23AT013838

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗