Online Mindful Self-Compassion Training for Medical Students: an Exploratory Feasibility Study

The goal of this clinical trial is to develop and investigate a compassion-based intervention (Self-Compassion for Healthcare Communities (SCHC) course) in medical students. The main objectives are:

1. Explore the feasibility of trial processes including recruitment, adherence, retention, and follow-up
2. Explore the experiences of medical students with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
3. Determine potential effects on burnout, compassion fatigue, compassion satisfaction, self-compassion, compassion for others, empathy, mindfulness, perceived stress, and emotional regulation.

Participants will be asked to take part in a 6-week online Self-Compassion for Healthcare Communities course and report changes in levels of burnout, compassion fatigue, compassion satisfaction, self-compassion, compassion for others, empathy, mindfulness, perceived stress, and emotional regulation 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 Overview

• Status: Recruiting
• Conditions: Self-Compassion
• Intervention / Treatment: Behavioral: Self-compassion intervention (Self-Compassion for Healthcare Communities course)

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Simpson, PhD; Phone Number: 40047 416-360-4000; Email: robert.simpson@uhn.ca
• Study Contact Backup: Name: Claire Zhang, BSc; Email: clairewt.zhang@mail.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1A1
      • Recruiting
      • University of Toronto
      • Contact: Robert Simpson, PhD; Phone Number: 40047 416-360-4000; Email: robert.simpson@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Enrolled in first or second-year of the MD or MD/PhD program at the University of Toronto,
2. Over 18 years of age,
3. Able to speak, read, and write in English,
4. Willing to take part in the SCHC course for up to the full 6-week duration,
5. Willing to complete all study related questionnaires

Exclusion Criteria:

1. Those already having completed a mindful self-compassion course or Mindfulness based-intervention (Mindfulness-based stress reduction or Mindfulness-based cognitive therapy) within the past 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-compassion intervention; 6-week manualized online Self-Compassion for Healthcare Communities course	Behavioral: Self-compassion intervention (Self-Compassion for Healthcare Communities course); An online 6-week mindful self-compassion course with weekly sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Adherence	The investigators will measure the number of participants who completed the Self-Compassion for Healthcare Communities course.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professional Quality of Life Scale (ProQOL) Version 5	Measures the positive and negative effects of one's compassion for those that they help. Includes with subscales for compassion satisfaction and compassion fatigue (including burnout). Answers are assessed using a 5-point Likert scale, with higher scores on the compassion satisfaction sub-scale indicating higher compassion satisfaction, and higher scores on compassion fatigue sub-scale indicating higher burnout.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Self-Compassion Scale - Short Form	Measures how one typically acts towards themselves in difficult times. The total score ranges from a 1-5, with higher scores representing high self-compassion.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Relational Compassion Scale	Measure's ones tendencies for receiving and providing relational compassion. Answers are assessed using a 4-point Likert scale. Higher scores represent higher compassion for self and others.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
The Brief Interpersonal Reactivity Index	Measures the different ways that people may think about their lives. Answers are assessed using a 5-point Likert scale, with higher scores representing higher empathic responsiveness.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Five Facet Mindfulness Questionnaire: Short Form	Measures one's tendencies to engage in mindfulness practices. Answers are assessed using a 5-point Likert scale, with higher scores representing more mindfulness.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Perceived Stress Scale-10	Measures one's thoughts and feelings pertaining to stress. The total score can range from 0-40, with higher scores indicating higher perceived stress.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Difficulties in Emotion Regulation Scale - Short Form	Measures emotion regulation. Answers are assessed using a 5-point Likert scale. Higher values indicate greater difficulties in emotion regulation.	Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Robert Simpson
• Investigators: Principal Investigator: Robert Simpson, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 00046332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No