REhabilitation of MEMory Symptoms After BRain 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: Cognitive behavioral therapy, Cognitive rehabilitation.
- Кому может быть актуально
- Состояния в реестре: Concussion, Brain, Mild Traumatic Brain Injury. Базовые параметры: 18 лет — 59 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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Обзор
Persistent memory symptoms after concussion are common, and likely perpetuated by unhelpful illness beliefs and coping behaviors. Results from a pilot study suggested that traditional cognitive rehabilitation and a novel cognitive-behavioral therapy (CBT) protocol were both associated with improvements in subjective memory functioning. The present study will more definitively compare the effectiveness of these interventions for improving subjective memory functioning after concussion.
Подробное описание
The primary research aims of this study are to determine whether cognitive behavioral therapy (CBT) and cognitive compensatory strategy training (CCST) improves subjective memory functioning compared to usual care, and to compare the effectiveness of CBT and CCST. This study is a multisite three-armed randomized control trial (RCT) that will randomize adults with persistent memory symptoms following concussion to CBT, CCST, or a covert waitlist condition (2:2:1). Participants will be blinded to the other arms of the study and the study hypotheses.
Вмешательства
- Поведенческое Cognitive behavioral therapy
Cognitive behavioral therapy (CBT) is delivered by a psychologist over 10 individual (1:1) manualized videoconference sessions. The goal of this therapy is for participants to use their memory more normally (i.e., reduce avoidance and safety behaviors) and view memory lapses as less threatening. - Поведенческое Cognitive rehabilitation
Cognitive compensatory strategy training (CCST), a traditional cognitive rehabilitation intervention, is delivered by a Occupational Therapist over 10 individual (1:1) manualized videoconference sessions. Participants optimize their use of current compensatory strategies and/or learn new ones suited to their needs and lifestyle. The goal is to minimize memory lapses in daily life.
Первичные конечные точки
- Multifactorial Memory Questionnaire-Satisfaction scale [Срок оценки: Week 20]
Вторичные конечные точки (3)
- Fear-Avoidance of Memory Loss Scale [Срок оценки: Week 1 and week 20]
- Patient Global Impression of Change scale [Срок оценки: Week 20]
- Work and Social Adjustment Scale [Срок оценки: Week 1 and week 20]
Критерии участия
Критерии включения
- Age 18-59
- Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria
- Concussion occurred between 6 and 36 months before enrollment
- Ongoing memory concerns
- Fluent in English
- Stable access to a computer, tablet, or smartphone with internet capability
Критерии исключения
- Fail performance validity testing
- Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms
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 · 8 центров
- Calgary Brain Injury Program — Calgary
- Fraser Health Acquired Brain Injury and Concussion Services — Langley
- G.F. Strong Adult Concussion Services — Vancouver
- Integrated Adult Concussion Program at Hamilton Health Sciences — Hamilton
- 360 Concussion Care Clinic — Ottawa
- Sunnybrook Traumatic Brain Injury Clinic — Toronto
- Hull-Ellis Concussion and Research Clinic at University Health Network — Toronto
- Canadian Concussion Centre at Toronto Western Hospital — Toronto
Публикации
- Rioux M, Mamman R, Byworth MT, Panenka WJ, Howard AK, Perez DL, Schmidt J, Courchesne C, LeMoult J, Heran MK, Silverberg ND. Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion. BMJ Neurol Open. 2024 Oct 11;6(2):e000666. doi: 10.1136/bmjno-2024-000666. eCollection 2024. PMID 39410977
Идентификаторы
NCT: NCT06956417 · H24-02486