Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT07097402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examination of a Self-Compassion Course for Healthcare Providers Working With People With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '6 months', 'description': 'The investigators will measure the number of participants eligible for and recruited to the study.'}, {'measure': 'Retention', 'timeFrame': '6 months', 'description': 'The investigators will measure the percentage of participants who complete outcome data.'}, {'measure': 'Adherence', 'timeFrame': '6 months', 'description': 'The investigators will measure the number of participants who completed the Self-Compassion for Healthcare Communities course.'}, {'measure': 'Follow-up rates', 'timeFrame': '6 months', 'description': 'The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Professional Quality of Life Scale (ProQOL) Version 5', 'timeFrame': 'Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention', 'description': "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."}, {'measure': 'Self-Compassion Scale - Short Form', 'timeFrame': 'Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention', 'description': '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.'}, {'measure': 'Relational Compassion Scale', 'timeFrame': 'Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention', 'description': "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."}, {'measure': 'Perceived Stress Scale-10', 'timeFrame': 'Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention', 'description': "Measures one's thoughts and feelings pertaining to stress. The total score can range from 0-40, with higher scores indicating higher perceived stress."}, {'measure': 'Difficulties in Emotion Regulation Scale - Short Form', 'timeFrame': 'Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention', 'description': 'Measures emotion regulation. Answers are assessed using a 5-point Likert scale. Higher values indicate greater difficulties in emotion regulation.'}, {'measure': 'Dispositional Joy Scale', 'timeFrame': 'Baseline, post-intervention (6 weeks after baseline), and 3 months post-intervention', 'description': 'Measures trait/dispositional joy. Answers are assessed using a 7-point Likert scale, with higher scores representing higher joy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout', 'Compassion']}, 'descriptionModule': {'briefSummary': "Clinical staff working with people with multiple sclerosis often face emotional fatigue and high levels of burnout. The Self-Compassion for Healthcare Communities course is an evidence-based intervention that teaches participants how to meet distress with kindness and care. This study will recruit up to 40 staff from the Barlo MS Clinic at St. Michael's Hospital to take part in a 6-week, 6-session Self-Compassion for Healthcare Communities course. Participants will be asked to complete surveys before and after the course to understand the effects of the course on a range of outcomes. Participants will be invited to take part in one qualitative interview on their perspectives on the course."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Able to understand spoken and written English\n3. Current professional affiliation with the Barlo MS clinic\n\nExclusion Criteria:\n\n1\\) Severe active mental health impairment (psychosis, suicidality)'}, 'identificationModule': {'nctId': 'NCT07097402', 'briefTitle': 'Examination of a Self-Compassion Course for Healthcare Providers Working With People With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Examination of a Self-Compassion Course for Healthcare Providers Working With People With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-compassion course', 'description': '6-week manualized online Self-Compassion for Healthcare Communities course', 'interventionNames': ['Behavioral: Self-compassion intervention (Self-Compassion for Healthcare Communities course)']}], 'interventions': [{'name': 'Self-compassion intervention (Self-Compassion for Healthcare Communities course)', 'type': 'BEHAVIORAL', 'description': 'An online 6-week mindful self-compassion course with weekly sessions.', 'armGroupLabels': ['Self-compassion course']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Robert Simpson, PhD', 'role': 'CONTACT', 'email': 'robert.simpson@uhn.ca', 'phone': '416-360-4000', 'phoneExt': '40047'}], 'facility': 'Unity Health Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Robert Simpson, PhD', 'role': 'CONTACT', 'email': 'robert.simpson@uhn.ca', 'phone': '416-360-4000', 'phoneExt': '40047'}, {'name': 'Jillian Scandiffio, MSc', 'role': 'CONTACT', 'email': 'jillian.scandiffio@unityhealth.to'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Simpson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Simpson', 'investigatorAffiliation': 'University of Toronto'}}}}