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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415552
• Other study ID #: Mindfulness for PwMS
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Unity Health Toronto
• Contact: Robert Simpson
• Phone: 416-360-4000
• Email: Robert.Simpson[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Robert Simpson

Outcome

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