Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study

Multiple Sclerosis Clinical Trial

Official title:

Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337903
• Other study ID #: Self-compassion for PwMS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 30, 2025

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Self-Compassion

Intervention

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

Locations

Country	Name	City	State
Canada	Unity Health Toronto	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Robert Simpson

Country where clinical trial is conducted

Canada, 

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