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Набор скоро начнётся NCT07742579

Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression

Фаза III С лечением Multiple Sclerosis

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 Cognitive Therapy.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: от 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
Список центров уточняется — проверьте первичный протокол.
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

Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study

Обзор

This study will use a waiting list randomized controlled trial design with a mixed-methods research approach, including both quantitative and qualitative methods. Randomization helps minimize research bias and controls for participant and contextual factors that might otherwise make interpretation of results challenging. We will recruit 152 people with multiple sclerosis (PwMS) with any type of MS, who also have mild-moderate depression, aged 18 or greater, and able to understand spoken and written English. For the quantitative part, we will examine how much change in depression there is following mindfulness-based cognitive therapy (MBCT), as well as whether participants attend the course and complete study measures or not, and how much participants complete MBCT home practices. We will also examine how much change there is in fatigue, sleep pain, quality of life, and anxiety. For the qualitative part of the study, we will use semi-structured interviews to explore participant experiences of online MBCT, how people used online MBCT, what worked, what didn't and why, how online MBCT impacted self-management of depression, and suggestions for improving the course to make it more relevant for PwMS with depression.

Вмешательства

  • Другое Mindfulness-Based Cognitive Therapy
    Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks

Первичные конечные точки

  • Depression [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
Вторичные конечные точки (12)
  • Self-efficacy [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Self-management [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Stigma [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Fatigue [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Sleep [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Change in pain [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Change in quality of life [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Anxiety [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Mindfulness [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Self-compassion [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Emotion regulation [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]
  • Group attendance [Срок оценки: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)]

Критерии участия

Inclusion criteria will include:

  • Age >/=18
  • Neurologist confirmed MS diagnosis (McDonald criteria)
  • Able to understand spoken and written English
  • A score of 14-28 on the Beck Depression Inventory-II signifying mild-moderate depression
  • Registered with a primary care provider (family physician or neurologist)
  • Residing in Canada

Exclusion criteria will include:

  • Potentially life-threatening comorbidities (suicidal ideation (i.e., score of 2 or 3 on the BDI-Fast Screen suicidal ideation question), history of psychosis, terminal/life threatening inter-current illness), or those such conditions expected to significantly limit participation and adherence (pregnancy, cognitive impairment i.e. score <26 on the Montreal Cognitive Assessment - MoCA)
  • Receipt of MBCT in the past 2 years (completed at least 4/8 sessions).

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07742579 · 00049655

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗