Multiple SclerosisPhase 3NCT07742579
Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression
A Phase 3 study testing Mindfulness-Based Cognitive Therapy in people with Multiple Sclerosis, run by Robert Simpson.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- mindfulness, Mindfulness-Based Cognitive Therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyOther
Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Online group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks Receives: Other: Mindfulness-Based Cognitive Therapy |
| Waitlist control | No intervention | Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Change in depression scores using the Hospital Anxiety and Depression Scale
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Secondary outcomes (16)
Self-efficacy
Self-efficacy, as measured by the Generalized Self-Efficacy Scale
Measured: 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
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Stigma
Stigma, as measured by the Stigma Scale for Chronic Illness-8
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Fatigue
Fatigue as measured by the Modified Fatigue Impact Scale
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Sleep
Sleep as measured by the Insomnia Severity Index
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in pain
Pain as measured by the Pain Effects Scale
Measured: 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
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Anxiety
Anxiety as measured by Hospital Anxiety and Depression Scale -Anxiety
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Mindfulness
Mindfulness as measured by The Five-facet Mindfulness Questionnaire
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-compassion
Self-compassion, measured using the The Self-Compassion Scale-short form
Measured: 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
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group attendance
Group attendance in those allocated to tailored online MBCT
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group climate
Group climate using the Climate Questionnaire-Engage Scale
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Therapeutic alliance
Therapeutic alliance as measured by the Working Alliance Inventory
Measured: 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)
Measured: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Implementation
Implementation, as informed by the Proctor's taxonomy
Measured: Throughout the study and up to 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Simpson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Simpson, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742579
- Sponsor's protocol ID
- 00049655
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness-Based Cognitive Therapy for People With Multiple Sclerosis With Mild-Moderate Depression: A Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT07742579
- Acronym / sponsor ID
- 00049655
- Conditions
- Multiple Sclerosis
- Keywords
- mindfulness, Mindfulness-Based Cognitive Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Robert SimpsonUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Other: Mindfulness-Based Cognitive TherapyOnline group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks |
| Waitlist control | No intervention | –Waitlist control arm - participants receive no intervention initially but receive MBCT following data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyOnline group Mindfulness-Based Cognitive Therapy delivered live online in weekly sessions for 8 weeks | Other | Mindfulness-Based Cognitive Therapy |
Primary outcome
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
16 secondary outcomes
Self-efficacy
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-management
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Stigma
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Fatigue
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Sleep
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in pain
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Change in quality of life
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Anxiety
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Mindfulness
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Self-compassion
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Emotion regulation
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group attendance
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Group climate
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Therapeutic alliance
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Depressive symptoms
Time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)
Implementation
Time frame: Throughout the study and up to 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mindfulness-Based Cognitive Therapy in people with Multiple Sclerosis, run by Robert Simpson.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Simpson (416-978-8383, rab.simpson@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline (T0), immediately post MBCT (T1), and 3 months later (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.