Online Mindful Self-Compassion Training for Medical Students: An Exploratory Feasibility Study
NCT Number: NCT06538597
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Self-Compassion
Interventions: BEHAVIORAL: Self-compassion intervention (Self-Compassion for Healthcare Communities course)
Sponsor: Robert Simpson
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-08
Locations: University of Toronto, Toronto, Ontario, M5S 1A1, Canada

Summary:
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.

Primary Outcome Measures: 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 Self-Compassion for Healthcare Communities 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 Outcome Measures: 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