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NCT Number: NCT07742579

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness-based cognitive therapy

Other

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

Primary outcomes

  1. Depression

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

    Change in depression scores using the Hospital Anxiety and Depression Scale

Secondary outcomes

  1. Self-efficacy

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

    Self-efficacy, as measured by the Generalized Self-Efficacy Scale

  2. Self-management

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

    Self-management, as measured by the Multiple-Sclerosis Self-Management Scale-Revised

  3. Stigma

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

    Stigma, as measured by the Stigma Scale for Chronic Illness-8

  4. Fatigue

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

    Fatigue as measured by the Modified Fatigue Impact Scale

  5. Sleep

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

    Sleep as measured by the Insomnia Severity Index

  6. Change in pain

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

    Pain as measured by the Pain Effects Scale

  7. Change in quality of life

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

    Quality of life as measured by the Multiple Sclerosis Impact Scale-29

  8. Anxiety

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

    Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety

  9. Mindfulness

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

    Mindfulness as measured by The Five-facet Mindfulness Questionnaire

  10. Self-compassion

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

    Self-compassion, measured using the The Self-Compassion Scale-short form

  11. Emotion regulation

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

    Emotion regulation, as measured by The Difficulties with Emotional Regulation Scale short-form

  12. Group attendance

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

    Group attendance in those allocated to tailored online MBCT

  13. Group climate

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

    Group climate using the Climate Questionnaire-Engage Scale

  14. Therapeutic alliance

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

    Therapeutic alliance as measured by the Working Alliance Inventory

  15. Depressive symptoms

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

    Depressive symptoms as measured by the Beck Depression Inventory II (BDI-II)

  16. Implementation

    Time frame: Throughout the study and up to 12 months post-intervention

    Implementation, as informed by the Proctor's taxonomy

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Simpson

CONTACT

[email protected]

416-978-8383

Sponsors and collaborators

Lead sponsor

Robert Simpson

Other

Registry information

Official study title

Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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