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Not yet recruiting NCT06415552

Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Based Stress Reduction.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Mindfulness-Based Stress Reduction
    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.

Primary outcome measures

  • Recruitment [Time frame: 24 months]
  • Retention [Time frame: 24 months]
  • Adherence [Time frame: 24 months]
  • Follow-up rates [Time frame: 24 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • St. Michael's Hospital — Toronto

Identifiers

NCT: NCT06415552 · Mindfulness for PwMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗