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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Mindfulness-Based Cognitive Therapy

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Robert Simpson; Phone Number: 416-978-8383; Email: rab.simpson@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Cognitive Therapy; Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks	Other: Mindfulness-Based Cognitive Therapy; Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
No Intervention: Waitlist control; Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Change in depression scores using the Hospital Anxiety and Depression Scale	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	Self-efficacy, as measured by the Generalized Self-Efficacy Scale	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-management	Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Stigma	Stigma, as measured by the Stigma Scale for Chronic Illness-8	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Fatigue	Fatigue as measured by the Modified Fatigue Impact Scale	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Sleep	Sleep as measured by the Insomnia Severity Index	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in pain	Pain as measured by the Pain Effects Scale	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in quality of life	Quality of life as measured by the Multiple Sclerosis Impact Scale-29	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Anxiety	Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Mindfulness	Mindfulness as measured by The Five-facet Mindfulness Questionnaire	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-compassion	Self-compassion, measured using the The Self-Compassion Scale-short form	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Emotion regulation	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	Group attendance in those allocated to tailored online MBCT	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group climate	Group climate using the Climate Questionnaire-Engage Scale	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Therapeutic alliance	Therapeutic alliance as measured by the Working Alliance Inventory	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Depressive symptoms	Depressive symptoms as measured by the Beck Depression Inventory II (BDI-II)	Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Implementation	Implementation, as informed by the Proctor's taxonomy	Throughout the study and up to 12 months post-intervention

Collaborators and Investigators

• Sponsor: Robert Simpson

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mindfulness; Mindfulness-Based Cognitive Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Cognitive Therapy
• Other Study ID Numbers: 00049655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No