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.
調査の概要
研究の種類
介入
入学 (推定)
152
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Robert Simpson
- 電話番号：416-978-8383
- メール：rab.simpson@utoronto.ca
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
介入なし：Waitlist control
Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-efficacy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年11月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月28日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 00049655
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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