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

NCT ID: NCT06337903

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-04-30

Brief Summary

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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:

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.

Detailed Description

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Conditions

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Multiple Sclerosis Self-Compassion

Keywords

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Mindfulness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Self-compassion intervention

8-week manualized online Mindful Self-Compassion course

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Simpson

OTHER

Sponsor Role lead

Responsible Party

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Robert Simpson

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert Simpson, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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Unity Health Toronto

Toronto, , Canada

Site Status

Countries

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Canada

Central Contacts

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Robert Simpson, PhD

Role: CONTACT

Phone: 416-360-4000

Email: [email protected]

Jillian Scandiffio, MSc

Role: CONTACT

Phone: 416-360-4000

Email: [email protected]

Facility Contacts

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Robert Simpson, PhD

Role: primary

Other Identifiers

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Self-compassion for PwMS

Identifier Type: -

Identifier Source: org_study_id