NCT06538597

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

Trial Health

57
Monitor

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 P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 1, 2024

Last Update Submit

March 25, 2025

Conditions

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 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 Outcomes (7)

  • Professional Quality of Life Scale (ProQOL) Version 5

    Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention

  • Self-Compassion Scale - Short Form

    Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention

  • Relational Compassion Scale

    Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention

  • The Brief Interpersonal Reactivity Index

    Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention

  • Five Facet Mindfulness Questionnaire: Short Form

    Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention

  • +2 more secondary outcomes

Study Arms (1)

Self-compassion intervention

EXPERIMENTAL

6-week manualized online Self-Compassion for Healthcare Communities course

Behavioral: Self-compassion intervention (Self-Compassion for Healthcare Communities course)

Interventions

An online 6-week mindful self-compassion course with weekly sessions.

Self-compassion intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 1A1, Canada

RECRUITING

Study Officials

  • Robert Simpson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Simpson, PhD

CONTACT

Claire Zhang, BSc

CONTACT

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
Assistant Professor, Department of Medicine

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 6, 2024

Study Start

February 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 30, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations