## Protocol Section
### Identification Module
**NCT ID:** NCT06415552

**Brief Title:** Implementation of Online Mindfulness-Based Stress Reduction Tailored for People With Multiple Sclerosis

**Official Title:** Implementation of Online Mindfulness-Based Stress Reduction Tailored for People With Multiple Sclerosis

#### Organization Study ID Info
**ID:** Mindfulness for PwMS
#### Organization
**Class:** OTHER
**Full Name:** Unity Health Toronto
### Status Module
#### Completion Date
**Date:** 2027-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Robert Simpson

#### Responsible Party

**Investigator Affiliation:** Unity Health Toronto

**Investigator Full Name:** Robert Simpson

**Investigator Title:** Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

**Keywords:**

- Mindfulness

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 8-week Mindfulness-Based Stress Reduction course

**Intervention Names:**

- Behavioral: Mindfulness-Based Stress Reduction

**Label:** Mindfulness-Based Stress Reduction

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mindfulness-Based Stress Reduction

**Description:** 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.

**Name:** Mindfulness-Based Stress Reduction

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Recruitment

**Time Frame:** 24 months

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

**Measure:** Retention

**Time Frame:** 24 months

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

**Measure:** Adherence

**Time Frame:** 24 months

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

**Measure:** Follow-up rates

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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

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

**Measure:** Quality of Life using the EuroQol (EQ-5D-5L)

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

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

**Measure:** Anxiety

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

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

**Measure:** Depression

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

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

**Measure:** Health services use

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

**Description:** 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.

**Measure:** Emotion regulation

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

**Description:** 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.

**Measure:** Self-compassion

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

**Description:** 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.

**Measure:** Mindfulness

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

**Description:** 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.

**Measure:** Climate

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

**Description:** 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.

**Measure:** Therapeutic alliance

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

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

**Measure:** Sleep

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

**Description:** 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.

**Measure:** Pain Effects

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

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

**Measure:** Fatigue

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

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

**Measure:** Cognitive function

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

### Eligibility Module

**Eligibility Criteria:** 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)

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Robert.Simpson@unityhealth.to

**Name:** Robert Simpson

**Phone:** 416-360-4000

**Phone Ext:** 40047

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-31
