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

NCT07742579 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 00049655
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

mindfulness; Mindfulness-Based Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Depression

  Change in depression scores using the Hospital Anxiety and Depression Scale

  Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

Secondary Outcomes (16)

• Self-efficacy

  Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

• Self-management

  Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

• Stigma

  Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

• Fatigue

  Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

• Sleep

  Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

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

Other: Mindfulness-Based Cognitive Therapy

Waitlist control

NO INTERVENTION

Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection

Interventions

Mindfulness-Based Cognitive Therapy OTHER

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

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Robert Simpson: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Robert Simpson

CONTACT

416-978-8383; rab.simpson@utoronto.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-01