Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression
2026年7月28日 更新者：Robert Simpson
Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study
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.
研究概览
研究类型
介入性
注册 (估计的)
152
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Robert Simpson
- 电话号码：416-978-8383
- 邮箱：rab.simpson@utoronto.ca
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Mindfulness-Based Cognitive Therapy
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
|
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
|
|
无干预：Waitlist control
Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Change in depression scores using the Hospital Anxiety and Depression Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-efficacy
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Self-efficacy, as measured by the Generalized Self-Efficacy Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Self-management
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Stigma
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Stigma, as measured by the Stigma Scale for Chronic Illness-8
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Fatigue
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Fatigue as measured by the Modified Fatigue Impact Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Sleep
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Sleep as measured by the Insomnia Severity Index
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Change in pain
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Pain as measured by the Pain Effects Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Change in quality of life
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Quality of life as measured by the Multiple Sclerosis Impact Scale-29
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Anxiety
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Mindfulness
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Mindfulness as measured by The Five-facet Mindfulness Questionnaire
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Self-compassion
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Self-compassion, measured using the The Self-Compassion Scale-short form
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Emotion regulation
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Emotion regulation, as measured by The Difficulties with Emotional Regulation Scale short-form
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Group attendance
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Group attendance in those allocated to tailored online MBCT
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Group climate
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Group climate using the Climate Questionnaire-Engage Scale
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Therapeutic alliance
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Therapeutic alliance as measured by the Working Alliance Inventory
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Depressive symptoms
大体时间：Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
Depressive symptoms as measured by the Beck Depression Inventory II (BDI-II)
|
Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
|
|
Implementation
大体时间：Throughout the study and up to 12 months post-intervention
|
Implementation, as informed by the Proctor's taxonomy
|
Throughout the study and up to 12 months post-intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2028年11月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年7月23日
首先提交符合 QC 标准的
2026年7月28日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年1月1日
更多信息
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