- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997082
A Mindful Self-compassion Based Intervention for Specialist Rehabilitation Providers
December 23, 2024 updated by: Dr. Robert Simpson, Sunnybrook Health Sciences Centre
Mindful Self-compassion, Compassion Fatigue, Secondary Traumatic Stress, and Burnout Among Specialist Rehabilitation Providers - a Mixed Methods Study Protocol
The goal of this clinical trial is to explore the impact of an online compassion-based intervention on burnout among specialist rehabilitation providers.
Post-intervention interviews aim to gather information on: burnout and compassion, experiences with the intervention, barriers and facilitators to taking part, and suggestions for improving online course delivery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Burnout threatens the sustainability of compassionate care in rehabilitation.
This project explores the impact of an online compassion-based intervention on burnout among specialist inpatient rehabilitation healthcare providers.
Thirty specialist rehabilitation healthcare providers will be recruited to take part.
The online intervention will include six weekly live one-hour sessions.
Healthcare provider socio-demographic, practice, and wellness measures will be collected at baseline, post-course, and three months later.
Qualitative interviews will be used to explore participant views on burnout and compassion, experiences with the intervention, barriers and facilitators to taking part, and suggestions for improving online course delivery.
Up to two instructors and support persons will be invited to participate in qualitative interviews to explore their views for improving online course delivery.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3H2L4
- St. John's Rehab (Sunnybrook Health Sciences Centre)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Employed substantively as a regulated health professional (e.g., physiatrist, nurse, allied health professional) by a specialist rehabilitation institute (e.g., Sunnybrook/St. John's Rehab, University Hospital Network, Providence Healthcare, Westpark Healthcare)
- Over 18 years of age
- Able to speak, read, and write in English
- Willing to take part in the MSC course for up to the full 6-week duration
- Willing to complete all study related questionnaires
Exclusion Criteria:
- Those already having completed a MSC (mindfulness-based stress reduction) course or mindfulness-based cognitive therapy within the past 12 months
- Those employed as agency staff
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants in the intervention
Participants in the intervention will participate in the 6-week mindfulness self-compassion course delivered online.
|
This course is designed to reduce burnout and compassion fatigue among specialist rehabilitation providers.
Course materials are adapted from the Center for Mindful Self-Compassion (CMSC).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Professional Quality of Life Scale (ProQOL) Version 5
Time Frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
Measures the positive and negative effects of one's compassion for those that they help rehabilitate.
|
Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relational Compassion Scale
Time Frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
Measure's ones tendencies for receiving and providing relational compassion.
|
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
|
Measures how one typically acts towards themselves in difficult times.
|
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.
|
Measures the different ways that people may think about their lives.
|
Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention.
|
|
5 Facet Mindfulness Questionnaire: Short Form
Time Frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
Measures one's tendencies to engage in mindfulness practices.
|
Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
|
Perceived Stress Scale
Time Frame: Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
Measures one's thoughts and feelings pertaining to stress.
|
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
|
Measures emotion regulation.
|
Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert Simpson, Md, PhD, Sunnybrook Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2023
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
August 10, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5492
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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