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NCT07742579Not yet recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
152 (estimated)
First submitted
23 Jul 2026
Start date
1 Aug 2026
Primary completion date
30 Nov 2028
Lead sponsor
Robert Simpson
NCT number
NCT07742579

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 152
  • From 1 Aug 2026 to the primary completion date, 30 Nov 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Other

  • Receipt of MBCT in the past 2 years (completed at least 4/8 sessions).

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.