Clinical trial NCT06337903: Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study
Official title: Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Self-Compassion
Keywords: Mindfulness
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment
timeFrame: 4 months
measure: Retention
timeFrame: 4 months
measure: Adherence
timeFrame: 4 months
measure: Follow-up rates
timeFrame: 4 months
Secondary outcomes:
measure: Stress
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Anxiety
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Depression
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Self-compassion
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Emotion Regulation
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Participant Experiences and Perspectives
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
measure: Adjustment
timeFrame: Measured at baseline, 8-week follow-up, and 3-month follow-up.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto
Study officials:
affiliation: Unity Health Toronto
name: Robert Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References: