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

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis; Self-Compassion
• Interventions: Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)

• Registration Number: NCT06337903
• Lead Sponsor: Robert Simpson

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-03-29
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Start: 2025-01-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self-compassion intervention	Self-compassion intervention (the Mindful Self-Compassion course)	8-week manualized online Mindful Self-Compassion course

Primary Outcome Measures

Name	Time	Method
Adherence	4 months	The investigators will measure the number of participants who completed the mindful self-compassion course.
Recruitment	4 months	The investigators will measure the number of participants eligible for and recruited to the study.
Retention	4 months	The investigators will measure the percentage of participants who complete outcome data.
Follow-up rates	4 months	The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.

Secondary Outcome Measures

Name	Time	Method
Anxiety	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.
Depression	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 depressive symptoms.
Stress	Measured at baseline, 8-week follow-up, and 3-month follow-up.	Measured using the Perceived Stress Scale-10. The total score can range from 0-40, with higher scores indicating higher perceived stress.
Self-compassion	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.
Emotion Regulation	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.
Adjustment	Measured at baseline, 8-week follow-up, and 3-month follow-up.	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.
Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)	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.
Participant Experiences and Perspectives	Measured at baseline, 8-week follow-up, and 3-month follow-up.	Semi-structured interviews will aim to capture participants' experiences with the course and perspectives on the use of self-compassion in care.

Trial Locations

Locations (1)

Unity Health Toronto; 🇨🇦 Toronto, Canada