An interventional study of Self-compassion intervention (the Mindful Self-Compassion course) in Multiple Sclerosis and Self-Compassion, sponsored by Robert Simpson. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Robert Simpson · Not applicable, Interventional, and Health services research
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:
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Robert Simpson is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Recruitment
The investigators will measure the number of participants eligible for and recruited to the study.
Time frame: 4 months
Retention
The investigators will measure the percentage of participants who complete outcome data.
Time frame: 4 months
Adherence
The investigators will measure the number of participants who completed the mindful self-compassion course.
Time frame: 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.
Time frame: 4 months
Stress
Measured using the Perceived Stress Scale-10. The total score can range from 0-40, with higher scores indicating higher perceived stress.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Robert Simpson