NCT06337903

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. 1.Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
  2. 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. 3.Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 19, 2024

Last Update Submit

December 3, 2024

Conditions

Multiple SclerosisSelf-Compassion

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (8)

  • Stress

    Measured at baseline, 8-week follow-up, and 3-month follow-up.

  • 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.

  • 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.

  • +3 more secondary outcomes

Study Arms (1)

Self-compassion intervention

EXPERIMENTAL

8-week manualized online Mindful Self-Compassion course

Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)

Interventions

Self-compassion intervention (the Mindful Self-Compassion course)BEHAVIORAL

An online 8-week mindful self-compassion course with weekly sessions.

Self-compassion intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unity Health Toronto

Toronto, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Robert Simpson, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Simpson, PhD

CONTACT

416-360-4000Robert.Simpson@unityhealth.to

Jillian Scandiffio, MSc

CONTACT

416-360-4000jillian.scandiffio@unityhealth.to

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 29, 2024

Study Start

January 1, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)