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NCT Number: NCT06415552

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Canada

Location contact

Jillian Scandiffio

CONTACT

[email protected]

416-360-4000x40047

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment

    Time frame: 24 months

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

  2. Retention

    Time frame: 24 months

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

  3. Adherence

    Time frame: 24 months

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

  4. Follow-up rates

    Time frame: 24 months

    The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.

Secondary outcomes

  1. Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)

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

    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.

  2. Quality of Life using the EuroQol (EQ-5D-5L)

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

    Measured using the EQ-5D-5L. The total score ranges from 1-100, with higher values indicating better perceived health.

  3. Anxiety

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

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

  4. Depression

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

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

  5. Health services use

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

    Measured using the Client Services Receipt Inventory. This instrument is used to collect information on the use of health services.

  6. Emotion regulation

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

    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.

  7. Self-compassion

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

    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.

  8. Mindfulness

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

    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.

  9. Climate

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

    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.

  10. Therapeutic alliance

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

    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.

  11. Sleep

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

    Measured using the Insomnia Severity Index. The total score ranges from 0-28, with higher scores indicating worse insomnia.

  12. Pain Effects

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

    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.

  13. Fatigue

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

    Measured using the Modified Fatigue Impact Scale. The total score ranges from 0-84, with higher scores indicating a greater impact of fatigue.

  14. Cognitive function

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

    Measured using the Symbol Digits Modalities Test. The total score ranges from 0-110, with higher scores indicating better cognitive functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Simpson

CONTACT

[email protected]

416-360-4000 ext. 40047

Sponsors and collaborators

Lead sponsor

Robert Simpson

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 16, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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