Multiple SclerosisNCT06337903
Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study
A study testing Self-compassion intervention (the Mindful Self-Compassion course) in people with Multiple Sclerosis and Self-Compassion, run by Robert Simpson at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Self-Compassion
- What is being tested?
- Self-compassion intervention (the Mindful Self-Compassion course)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Able to understand spoken and written English
- Have a neurologist-confirmed diagnosis of multiple sclerosis
- Willing to take place in an Mindful Self Compassion course
Who cannot join
- Cognitive impairment (<26 on the Montreal Cognitive Assessment)
- Severe active mental health impairment (psychosis, suicidality)
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
- Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
- 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.
- Conditions
- Multiple Sclerosis, Self-Compassion
- Being tested
- Self-compassion intervention (the Mindful Self-Compassion course)
- Keywords
- Mindfulness
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion intervention (the Mindful Self-Compassion course)Behavioural
An online 8-week mindful self-compassion course with weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion intervention | Experimental | 8-week manualized online Mindful Self-Compassion course Receives: Behavioral: Self-compassion intervention (the Mindful Self-Compassion course) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The investigators will measure the number of participants eligible for and recruited to the study.
Measured: 4 months
Retention
The investigators will measure the percentage of participants who complete outcome data.
Measured: 4 months
Adherence
The investigators will measure the number of participants who completed the mindful self-compassion course.
Measured: 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.
Measured: 4 months
Secondary outcomes (8)
Stress
Measured using the Perceived Stress Scale-10. The total score can range from 0-40, with higher scores indicating higher perceived stress.
Measured: 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.
Measured: 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: 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: 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: 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: 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: 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: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Simpson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Simpson, Unity Health Toronto
- Investigators
- Robert Simpson, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337903
- Sponsor's protocol ID
- Self-compassion for PwMS
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study
- ClinicalTrials.gov ID
- NCT06337903
- Acronym / sponsor ID
- Self-compassion for PwMS
- Conditions
- Multiple Sclerosis, Self-Compassion
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Robert SimpsonUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
- Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-compassion intervention | Experimental | Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)8-week manualized online Mindful Self-Compassion course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Able to understand spoken and written English
- Have a neurologist-confirmed diagnosis of multiple sclerosis
- Willing to take place in an Mindful Self Compassion course
Key exclusion criteria (2 listed)
- Cognitive impairment (<26 on the Montreal Cognitive Assessment)
- Severe active mental health impairment (psychosis, suicidality)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion intervention (the Mindful Self-Compassion course)An online 8-week mindful self-compassion course with weekly sessions. | Behavioural | Self-compassion intervention |
Primary outcome
Recruitment
Time frame: 4 months
The investigators will measure the number of participants eligible for and recruited to the study.
Retention
Time frame: 4 months
The investigators will measure the percentage of participants who complete outcome data.
Adherence
Time frame: 4 months
The investigators will measure the number of participants who completed the mindful self-compassion course.
Follow-up rates
Time frame: 4 months
The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.
8 secondary outcomes
Stress
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Anxiety
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Depression
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Self-compassion
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
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)
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Participant Experiences and Perspectives
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Adjustment
Time frame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Simpson, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion intervention (the Mindful Self-Compassion course) in people with Multiple Sclerosis and Self-Compassion, run by Robert Simpson at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Simpson, PhD (416-360-4000 ext. 40047, Robert.Simpson@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.