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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06337903
Enrollment
45
Registered
2024-03-29
Start date
2025-01-01
Completion date
2025-04-30
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Self-Compassion

Keywords

Mindfulness

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.

Interventions

BEHAVIORALSelf-compassion intervention (the Mindful Self-Compassion course)

An online 8-week mindful self-compassion course with weekly sessions.

Sponsors

Robert Simpson
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Recruitment4 monthsThe investigators will measure the number of participants eligible for and recruited to the study.
Retention4 monthsThe investigators will measure the percentage of participants who complete outcome data.
Adherence4 monthsThe investigators will measure the number of participants who completed the mindful self-compassion course.
Follow-up rates4 monthsThe investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.

Secondary

MeasureTime frameDescription
Emotion RegulationMeasured 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.
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.
StressMeasured 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.
AdjustmentMeasured 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.
Participant Experiences and PerspectivesMeasured 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.
AnxietyMeasured 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.
DepressionMeasured 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.
Self-compassionMeasured 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.

Countries

Canada

Contacts

Primary ContactRobert Simpson, PhD
Robert.Simpson@unityhealth.to416-360-4000
Backup ContactJillian Scandiffio, MSc
jillian.scandiffio@unityhealth.to416-360-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026