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Clinical Trials/NCT06337903
NCT06337903
Not yet recruiting
Not Applicable

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

Robert Simpson1 site in 1 country45 target enrollmentJanuary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Robert Simpson
Enrollment
45
Locations
1
Primary Endpoint
Adherence
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Robert Simpson
Responsible Party
Sponsor Investigator
Principal Investigator

Robert Simpson

Investigator

Unity Health Toronto

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Cognitive impairment (\<26 on the Montreal Cognitive Assessment)
  • Severe active mental health impairment (psychosis, suicidality)

Outcomes

Primary Outcomes

Adherence

Time Frame: 4 months

The investigators will measure the number of participants who completed the mindful self-compassion course.

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.

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.

Secondary Outcomes

  • Anxiety(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Depression(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Stress(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Self-compassion(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Emotion Regulation(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Adjustment(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
  • Participant Experiences and Perspectives(Measured at baseline, 8-week follow-up, and 3-month follow-up.)

Study Sites (1)

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