Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study

The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:

1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.

Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis; Self-Compassion
• Intervention / Treatment: Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Simpson, PhD; Phone Number: 40047 416-360-4000; Email: Robert.Simpson@unityhealth.to
• Study Contact Backup: Name: Jillian Scandiffio, MSc; Phone Number: 40047 416-360-4000; Email: jillian.scandiffio@unityhealth.to

Study Locations

• Canada
  • Toronto, Canada
    • Unity Health Toronto
    • Contact: Robert Simpson, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Aged 18 years or older
2. Able to understand spoken and written English
3. Have a neurologist-confirmed diagnosis of multiple sclerosis
4. Willing to take place in an Mindful Self Compassion course

Exclusion Criteria:

1. Cognitive impairment (<26 on the Montreal Cognitive Assessment)
2. Severe active mental health impairment (psychosis, suicidality)

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
Experimental: Self-compassion intervention; 8-week manualized online Mindful Self-Compassion course	Behavioral: Self-compassion intervention (the Mindful Self-Compassion course); An online 8-week mindful self-compassion course with weekly sessions.

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.	4 months
Retention	The investigators will measure the percentage of participants who complete outcome data.	4 months
Adherence	The investigators will measure the number of participants who completed the mindful self-compassion course.	4 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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Measured using the Perceived Stress Scale-10. The total score can range from 0-40, with higher scores indicating higher perceived stress.	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 depressive symptoms.	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.
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.
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.
Participant Experiences and Perspectives	Semi-structured interviews will aim to capture participants' experiences with the course and perspectives on the use of self-compassion in care.	Measured at baseline, 8-week follow-up, and 3-month follow-up.
Adjustment	Measured using the Coping with MS Scale. Answers are assessed using a 5-point Likert scale and a mean per subscale group will be reported. Higher values indicate greater tendency to use coping strategies.	Measured at baseline, 8-week follow-up, and 3-month follow-up.

Collaborators and Investigators

• Sponsor: Robert Simpson
• Investigators: Principal Investigator: Robert Simpson, PhD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Self-compassion 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
• product manufactured in and exported from the U.S.: No