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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRobert Simpson

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Mindfulness-Based Stress Reduction

    Behavioral

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Mindfulness-Based Stress ReductionOther 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment

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

Time frame
24 months
2

Retention

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

Time frame
24 months
3

Adherence

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

Time frame
24 months
4

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.

Time frame
24 months

Secondary outcomes

1

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.

Time frame
Measured at baseline, 8-week follow-up, and 3-month follow-up
2

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.

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

Anxiety

Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.

Time frame
Measured at baseline, 8-week follow-up, and 3-month follow-up
4

Depression

Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.

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

Other outcomes

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: