Multiple SclerosisNCT06415552
Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis
A study testing Mindfulness-Based Stress Reduction in people with Multiple Sclerosis, run by Robert Simpson at 1 site in Canada.
Trial summary
This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to 31 May 2027
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 years </= 60 years
- Diagnosis of MS or related condition (Clinically Isolated Syndrome, Neuromyelitis Optica Spectrum Disorder, Chronic Inflammatory Demyelinating Neuropathy)
- Able to understand spoken and written English
- Willing to take part in an MBSR course
Who cannot join
- Cognitive impairment (<26 on the Montreal Cognitive Assessment)
- Severe active mental health impairment (psychosis, suicidality)
- Medical instability (terminal/life threatening inter-current illness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Michael's Hospital
Toronto
Jillian Scandiffio, 416-360-4000x40047, jillian.scandiffio@unityhealth.to
About this study
This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings.
Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.
- Conditions
- Multiple Sclerosis
- Being tested
- Mindfulness-Based Stress Reduction
- Keywords
- Mindfulness
- 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 Stress ReductionBehavioural
Eight iterations of the MBSR course will be delivered, over a total period of 24 months. Each iteration will take place over 8 weeks. Courses would consist of 8 weekly sessions, led by certified mindfulness instructors. Sessions will include core meditation practices, psychoeducation, and home practices.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Other | 8-week Mindfulness-Based Stress Reduction course Receives: Behavioral: Mindfulness-Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The investigators will measure the number of participants eligible for and recruited to the study.
Measured: 24 months
Retention
The investigators will measure the percentage of participants who complete outcome data.
Measured: 24 months
Adherence
The investigators will measure the number of participants who completed the mindfulness-based stress reduction course.
Measured: 24 months
Follow-up rates
The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.
Measured: 24 months
Secondary outcomes (14)
Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)
Measured using the Multiple Sclerosis Impact Scale. Items on the scale have a Likert scale from 1-5, with a range of 0-100 total and higher scores indicating greater disability.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Quality of Life using the EuroQol (EQ-5D-5L)
Measured using the EQ-5D-5L. The total score ranges from 1-100, with higher values indicating better perceived health.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Anxiety
Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Depression
Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Health services use
Measured using the Client Services Receipt Inventory. This instrument is used to collect information on the use of health services.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Emotion regulation
Measured using the Difficulties in Emotion Regulation Scale - Short Form. Answers are assessed using a 5-point Likert scale. Higher values indicate greater difficulties in emotion regulation.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Self-compassion
Measured using the Self-Compassion Scale - Short Form. The total score ranges from a 1-5 Likert scale, with higher scores representing high self-compassion.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Mindfulness
Measured using the Five-facet Mindfulness Questionnaire. Answers are assessed using a 5-point Likert scale. Higher scores in each facet indicate higher levels of mindfulness.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Climate
Measured using the Group Climate Questionnaire-Engage Scale. Each item response is measured on a Likert scale from 0-6, with total subscale scores reflecting the average of responses. Higher scores indicate higher group engagement.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Therapeutic alliance
Measured using the Working Alliance Inventory. Each item is measured on a 7-point Likert scale, with a range of 36-252 total. Higher scores indicates stronger alliance.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Sleep
Measured using the Insomnia Severity Index. The total score ranges from 0-28, with higher scores indicating worse insomnia.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Pain Effects
Measured using the Pain Effects Scale. The total score ranges from 6-30, with higher scores indicating greater impact of pain on behavior and mood.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Fatigue
Measured using the Modified Fatigue Impact Scale. The total score ranges from 0-84, with higher scores indicating a greater impact of fatigue.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Cognitive function
Measured using the Symbol Digits Modalities Test. The total score ranges from 0-110, with higher scores indicating better cognitive functioning.
Measured: Measured at baseline, 8-week follow-up, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Simpson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Simpson, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415552
- Sponsor's protocol ID
- Mindfulness for PwMS
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06415552
- Acronym / sponsor ID
- Mindfulness for PwMS
- Conditions
- Multiple Sclerosis
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Robert SimpsonUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 May 2024 (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 project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings.
Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Other | Behavioral: Mindfulness-Based Stress Reduction8-week Mindfulness-Based Stress Reduction course |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age >18 years </= 60 years
- Diagnosis of MS or related condition (Clinically Isolated Syndrome, Neuromyelitis Optica Spectrum Disorder, Chronic Inflammatory Demyelinating Neuropathy)
- Able to understand spoken and written English
- Willing to take part in an MBSR course
Key exclusion criteria (3 listed)
- Cognitive impairment (<26 on the Montreal Cognitive Assessment)
- Severe active mental health impairment (psychosis, suicidality)
- Medical instability (terminal/life threatening inter-current illness)
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 Stress ReductionEight iterations of the MBSR course will be delivered, over a total period of 24 months. Each iteration will take place over 8 weeks. Courses would consist of 8 weekly sessions, led by certified mindfulness instructors. Sessions will include core meditation practices, psychoeducation, and home practices. | Behavioural | Mindfulness-Based Stress Reduction |
Primary outcome
Recruitment
Time frame: 24 months
The investigators will measure the number of participants eligible for and recruited to the study.
Retention
Time frame: 24 months
The investigators will measure the percentage of participants who complete outcome data.
Adherence
Time frame: 24 months
The investigators will measure the number of participants who completed the mindfulness-based stress reduction course.
Follow-up rates
Time frame: 24 months
The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.
14 secondary outcomes
Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Quality of Life using the EuroQol (EQ-5D-5L)
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Anxiety
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Depression
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Health services use
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Emotion regulation
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Self-compassion
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Mindfulness
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Climate
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Therapeutic alliance
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Sleep
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Pain Effects
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Fatigue
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Cognitive function
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up
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 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Multiple Sclerosis, run by Robert Simpson at 1 site in Canada.
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 4 inclusion and 3 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 (416-360-4000 ext. 40047, Robert.Simpson@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 24 months). The study lists 4 primary outcomes in all. 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 6 Dec 2024.