About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cognitive impairment (<26 on the Montreal Cognitive Assessment)
Severe active mental health impairment (psychosis, suicidality)
Medical instability (terminal/life threatening inter-current illness)
Trial design
Single group
Treatments tested in this trial
Mindfulness-Based Stress Reduction
BehavioralEight 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.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment
The investigators will measure the number of participants eligible for and recruited to the study.
Retention
The investigators will measure the percentage of participants who complete outcome data.
Adherence
The investigators will measure the number of participants who completed the mindfulness-based stress reduction course.
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.
Secondary outcomes
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.
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.
Anxiety
Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.
Depression
Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Robert Simpson
Lead sponsor
Unity Health Toronto
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: