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

NCT ID: NCT06415552

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Mindfulness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Stress Reduction

8-week Mindfulness-Based Stress Reduction course

Group Type OTHER

Mindfulness-Based Stress Reduction

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Simpson

OTHER

Sponsor Role lead

Responsible Party

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Robert Simpson

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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St. Michael's Hospital

Toronto, , Canada

Site Status

Countries

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Canada

Central Contacts

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Robert Simpson

Role: CONTACT

Phone: 416-360-4000

Email: [email protected]

Facility Contacts

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Jillian Scandiffio

Role: primary

Other Identifiers

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Mindfulness for PwMS

Identifier Type: -

Identifier Source: org_study_id