Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 4:04 PM
Study NCT ID:
NCT06337903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '4 months', 'description': 'The investigators will measure the number of participants eligible for and recruited to the study.'}, {'measure': 'Retention', 'timeFrame': '4 months', 'description': 'The investigators will measure the percentage of participants who complete outcome data.'}, {'measure': 'Adherence', 'timeFrame': '4 months', 'description': 'The investigators will measure the number of participants who completed the mindful self-compassion course.'}, {'measure': 'Follow-up rates', 'timeFrame': '4 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': 'Stress', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Perceived Stress Scale-10. The total score can range from 0-40, with higher scores indicating higher perceived stress.'}, {'measure': 'Anxiety', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased anxiety symptoms.'}, {'measure': 'Depression', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Hospital Anxiety and Depression Scale. The total score ranges from 0-21, with higher values representing increased depressive symptoms.'}, {'measure': 'Self-compassion', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Self-Compassion Scale - Short Form. The total score ranges from a 1-5 Likert scale, with higher scores representing high self-compassion.'}, {'measure': 'Emotion Regulation', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Difficulties in Emotion Regulation Scale - Short Form. Answers are assessed using a 5-point Likert scale. Higher values indicate greater difficulties in emotion regulation.'}, {'measure': 'Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Multiple Sclerosis Impact Scale. Items on the scale have a Likert scale from 1-5, with a range of 0-100 total and higher scores indicating greater disability.'}, {'measure': 'Participant Experiences and Perspectives', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': "Semi-structured interviews will aim to capture participants' experiences with the course and perspectives on the use of self-compassion in care."}, {'measure': 'Adjustment', 'timeFrame': 'Measured at baseline, 8-week follow-up, and 3-month follow-up.', 'description': 'Measured using the Coping with MS Scale. Answers are assessed using a 5-point Likert scale and a mean per subscale group will be reported. Higher values indicate greater tendency to use coping strategies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness'], 'conditions': ['Multiple Sclerosis', 'Self-Compassion']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:\n\n1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up\n2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement\n3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.\n\nParticipants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Able to understand spoken and written English\n3. Have a neurologist-confirmed diagnosis of multiple sclerosis\n4. Willing to take place in an Mindful Self Compassion course\n\nExclusion Criteria:\n\n1. Cognitive impairment (\\<26 on the Montreal Cognitive Assessment)\n2. Severe active mental health impairment (psychosis, suicidality)'}, 'identificationModule': {'nctId': 'NCT06337903', 'briefTitle': 'Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study', 'orgStudyIdInfo': {'id': 'Self-compassion for PwMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-compassion intervention', 'description': '8-week manualized online Mindful Self-Compassion course', 'interventionNames': ['Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)']}], 'interventions': [{'name': 'Self-compassion intervention (the Mindful Self-Compassion course)', 'type': 'BEHAVIORAL', 'description': 'An online 8-week mindful self-compassion course with weekly sessions.', 'armGroupLabels': ['Self-compassion intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'country': 'Canada', 'contacts': [{'name': 'Robert Simpson, PhD', 'role': 'CONTACT'}], 'facility': 'Unity Health Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Robert Simpson, PhD', 'role': 'CONTACT', 'email': 'Robert.Simpson@unityhealth.to', 'phone': '416-360-4000', 'phoneExt': '40047'}, {'name': 'Jillian Scandiffio, MSc', 'role': 'CONTACT', 'email': 'jillian.scandiffio@unityhealth.to', 'phone': '416-360-4000', 'phoneExt': '40047'}], 'overallOfficials': [{'name': 'Robert Simpson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Simpson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Robert Simpson', 'investigatorAffiliation': 'Unity Health Toronto'}}}}