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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants in the intervention
Participants in the intervention will participate in the 6-week mindfulness self-compassion course delivered online.
Other: Mindfulness Self-Compassion Course
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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