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