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Набор скоро начнётся NCT07698015

Rehabilitation, Education, and SElf-management for Adolescents After Mild Traumatic Brain Injury

Без фазы С лечением Brain Concussion Mild Traumatic Brain Injury Concussion

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: Mindfulness-based intervention, Health Education.
Кому может быть актуально
Состояния в реестре: Brain Concussion, Mild Traumatic Brain Injury, Concussion. Базовые параметры: 12 лет — 18 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
Канада
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

A Decentralized, Investigator Blinded, Randomized, Parallel-group Study to Determine the Feasibility of an 8-week Smart-phone App Delivered Mindfulness- Based Intervention Versus a Health Education Program for Adolescents With Persisting Symptoms After Concussion/mTBI

Обзор

Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.

Вмешательства

  • Поведенческое Mindfulness-based intervention
    The mindfulness-based intervention (MBI) is delivered via a smartphone application called Dawn. The MBI consists of 8-week MBI program developed to meet the needs of adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and guided mindfulness exercises. The goal of this intervention is to support better coping with symptoms.
  • Поведенческое Health Education
    The health education program is delivered via a smartphone application called Dawn. It is an 8-week program designed to deliver information about health behaviors (e.g., sleep, exercise, nutrition, social support) that is inline with clinical practice guidelines for adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and health behavior tracking exercises. The goal of this intervention is to provide a credible, time- and attention-matched control group.

Первичные конечные точки

  • Eligibility [Срок оценки: pre-enrollment]
  • Recruitment rate [Срок оценки: at randomization]
  • Treatment Adherence [Срок оценки: post-intervention questionnaires (Week 8)]
  • Retention [Срок оценки: post-intervention questionnaires (Week 8)]
Вторичные конечные точки (2)
  • Treatment credibility and expectancy [Срок оценки: 7-14 days post-enrollment]
  • Treatment Satisfaction [Срок оценки: Post-intervention questionnaires (Week 8)]

Критерии участия

Критерии включения

  • Age 12-18
  • Structured interview confirming a concussion/mTBI or suspected concussion/mTBI diagnosis according to the American Congress of Rehabilitation Medicine definition
  • Concussion/mTBI occurred 1-12 months prior to randomization
  • Persisting symptoms after concussion as demonstrated by a score >75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group
  • English proficiency

Критерии исключения

  • Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis)
  • Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., <2 weeks post-injury).

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • BC Children's Hospital Research Institute — Vancouver

Идентификаторы

NCT: NCT07698015 · H25-01673

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗