NCT06415552

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
13mo left

Started Jan 2025

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jan 2025May 2027

First Submitted

Initial submission to the registry

May 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

December 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 8, 2024

Last Update Submit

December 3, 2024

Conditions

Multiple Sclerosis

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (4)

  • Recruitment

    The investigators will measure the number of participants eligible for and recruited to the study.

    24 months

  • Retention

    The investigators will measure the percentage of participants who complete outcome data.

    24 months

  • Adherence

    The investigators will measure the number of participants who completed the mindfulness-based stress reduction course.

    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.

    24 months

Secondary Outcomes (14)

  • Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)

    Measured at baseline, 8-week follow-up, and 3-month follow-up

  • Quality of Life using the EuroQol (EQ-5D-5L)

    Measured at baseline, 8-week follow-up, and 3-month follow-up

  • Anxiety

    Measured at baseline, 8-week follow-up, and 3-month follow-up

  • Depression

    Measured at baseline, 8-week follow-up, and 3-month follow-up

  • Health services use

    Measured at baseline, 8-week follow-up, and 3-month follow-up

  • +9 more secondary outcomes

Study Arms (1)

Mindfulness-Based Stress Reduction

OTHER

8-week Mindfulness-Based Stress Reduction course

Behavioral: Mindfulness-Based Stress Reduction

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

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.

Mindfulness-Based Stress Reduction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment (\<26 on the Montreal Cognitive Assessment)
  • Severe active mental health impairment (psychosis, suicidality)
  • Medical instability (terminal/life threatening inter-current illness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Robert Simpson

CONTACT

416-360-4000Robert.Simpson@unityhealth.to

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 16, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

December 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)