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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-compassion intervention | Experimental | 8-week manualized online Mindful Self-Compassion course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-compassion intervention (the Mindful Self-Compassion course) | Behavioral | An online 8-week mindful self-compassion course with weekly sessions. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Simpson, PhD | Contact | 416-360-4000 | 40047 | Robert.Simpson@unityhealth.to |
| Jillian Scandiffio, MSc | Contact | 416-360-4000 | 40047 | jillian.scandiffio@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Robert Simpson, PhD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unity Health Toronto | Toronto | Canada |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |