Self-CompassionNCT06538597
Online Mindful Self-Compassion Training for Medical Students: an Exploratory Feasibility Study
A study testing Self-compassion intervention (Self-Compassion for Healthcare Communities course) in people with Self-Compassion, run by Robert Simpson at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-Compassion
- What is being tested?
- Self-compassion intervention (Self-Compassion for Healthcare Communities course)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Claire Zhang, BSc contact
Canada1 site, 1 recruiting
- Recruiting
University of Toronto
Toronto, Ontario, M5S 1A1
Robert Simpson, PhD, 416-360-4000 ext. 40047, robert.simpson@uhn.ca
About this 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:
- Explore the feasibility of trial processes including recruitment, adherence, retention, and follow-up
- Explore the experiences of medical students with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
- 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.
- Conditions
- Self-Compassion
- Being tested
- Self-compassion intervention (Self-Compassion for Healthcare Communities course)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion intervention (Self-Compassion for Healthcare Communities course)Behavioural
An online 6-week mindful self-compassion course with weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion intervention | Experimental | 6-week manualized online Self-Compassion for Healthcare Communities course Receives: Behavioral: Self-compassion intervention (Self-Compassion for Healthcare Communities course) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The investigators will measure the number of participants eligible for and recruited to the study.
Measured: 4 months
Retention
The investigators will measure the percentage of participants who complete outcome data.
Measured: 4 months
Adherence
The investigators will measure the number of participants who completed the Self-Compassion for Healthcare Communities course.
Measured: 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.
Measured: 4 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-CompassionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Simpson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Simpson, University of Toronto
- Investigators
- Robert Simpson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538597
- Sponsor's protocol ID
- 00046332
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindful Self-Compassion Training for Medical Students: an Exploratory Feasibility Study
- ClinicalTrials.gov ID
- NCT06538597
- Acronym / sponsor ID
- 00046332
- Conditions
- Self-Compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Robert SimpsonUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Explore the feasibility of trial processes including recruitment, adherence, retention, and follow-up
- Explore the experiences of medical students with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-compassion intervention | Experimental | Behavioral: Self-compassion intervention (Self-Compassion for Healthcare Communities course)6-week manualized online Self-Compassion for Healthcare Communities course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion intervention (Self-Compassion for Healthcare Communities course)An online 6-week mindful self-compassion course with weekly sessions. | Behavioural | Self-compassion intervention |
Primary outcome
Recruitment
Time frame: 4 months
The investigators will measure the number of participants eligible for and recruited to the study.
Retention
Time frame: 4 months
The investigators will measure the percentage of participants who complete outcome data.
Adherence
Time frame: 4 months
The investigators will measure the number of participants who completed the Self-Compassion for Healthcare Communities course.
Follow-up rates
Time frame: 4 months
The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.
7 secondary outcomes
Professional Quality of Life Scale (ProQOL) Version 5
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Self-Compassion Scale - Short Form
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Relational Compassion Scale
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
The Brief Interpersonal Reactivity Index
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Five Facet Mindfulness Questionnaire: Short Form
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Perceived Stress Scale-10
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Difficulties in Emotion Regulation Scale - Short Form
Time frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Zhang, BSc contact
Robert Simpson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion intervention (Self-Compassion for Healthcare Communities course) in people with Self-Compassion, run by Robert Simpson at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Simpson, PhD (416-360-4000 ext. 40047, robert.simpson@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.