Clinical trial NCT06415552: Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis
Official title: Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Mindfulness
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years \</= 60 years
2. Diagnosis of MS or related condition (Clinically Isolated Syndrome, Neuromyelitis Optica Spectrum Disorder, Chronic Inflammatory Demyelinating Neuropathy)
3. Able to understand spoken and written English
4. Willing to take part in an MBSR course

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment
timeFrame: 24 months
measure: Retention
timeFrame: 24 months
measure: Adherence
timeFrame: 24 months
measure: Follow-up rates
timeFrame: 24 months
Secondary outcomes:
measure: Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Quality of Life using the EuroQol (EQ-5D-5L)
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Anxiety
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Depression
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Health services use
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Emotion regulation
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Self-compassion
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Mindfulness
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Climate
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Therapeutic alliance
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Sleep
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Pain Effects
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Fatigue
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
measure: Cognitive function
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
Study officials:
References: