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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Simpson; Phone Number: 40047 416-360-4000; Email: Robert.Simpson@unityhealth.to

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mindfulness-Based Stress Reduction; 8-week Mindfulness-Based Stress Reduction course	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	The investigators will measure the number of participants eligible for and recruited to the study.	24 months
Retention	The investigators will measure the percentage of participants who complete outcome data.	24 months
Adherence	The investigators will measure the number of participants who completed the mindfulness-based stress reduction course.	24 months
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured at baseline, 8-week follow-up, and 3-month follow-up
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.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Anxiety	Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Depression	Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Health services use	Measured using the Client Services Receipt Inventory. This instrument is used to collect information on the use of health services.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Emotion regulation	Measured using the Difficulties in Emotion Regulation Scale - Short Form. Answers are assessed using a 5-point Likert scale. Higher values indicate greater difficulties in emotion regulation.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Self-compassion	Measured using the Self-Compassion Scale - Short Form. The total score ranges from a 1-5 Likert scale, with higher scores representing high self-compassion.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Mindfulness	Measured using the Five-facet Mindfulness Questionnaire. Answers are assessed using a 5-point Likert scale. Higher scores in each facet indicate higher levels of mindfulness.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Climate	Measured using the Group Climate Questionnaire-Engage Scale. Each item response is measured on a Likert scale from 0-6, with total subscale scores reflecting the average of responses. Higher scores indicate higher group engagement.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Therapeutic alliance	Measured using the Working Alliance Inventory. Each item is measured on a 7-point Likert scale, with a range of 36-252 total. Higher scores indicates stronger alliance.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Sleep	Measured using the Insomnia Severity Index. The total score ranges from 0-28, with higher scores indicating worse insomnia.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Pain Effects	Measured using the Pain Effects Scale. The total score ranges from 6-30, with higher scores indicating greater impact of pain on behavior and mood.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Fatigue	Measured using the Modified Fatigue Impact Scale. The total score ranges from 0-84, with higher scores indicating a greater impact of fatigue.	Measured at baseline, 8-week follow-up, and 3-month follow-up
Cognitive function	Measured using the Symbol Digits Modalities Test. The total score ranges from 0-110, with higher scores indicating better cognitive functioning.	Measured at baseline, 8-week follow-up, and 3-month follow-up

Collaborators and Investigators

• Sponsor: Robert Simpson

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Mindfulness for PwMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No