Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 8:36 PM
Study NCT ID:
NCT05617300
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Leah.R.Hanson@HealthPartners.com', 'phone': '6514956352', 'title': 'Leah Hanson, PhD', 'organization': 'HealthPartners Neuroscience Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'Includes only participants who attended virtual MBDC program (n=124). Six participants were in live, in person course and not analyzed.', 'eventGroups': [{'id': 'EG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Number of the participants who attend the first class of their session. Enrolled is defined as a participant who is assigned to a course. Range \\[0-124\\]. A value closer to 124 is indicative of greater feasibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only participants who attended virtual MBDC program (n=124). Six participants were in live, in person course and not analyzed.'}, {'type': 'PRIMARY', 'title': 'Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'Percent of the participants who completed courses. Completion is defined as attending a minimum of 6 of the 9 classes. Range \\[0-100\\]. A value closer to 100 is indicative of greater feasibility.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only participants who attended virtual MBDC program (n=124). Eight participants were in live, in person courses and were not analyzed.'}, {'type': 'PRIMARY', 'title': 'Questionnaire Specific Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.8', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires.', 'unitOfMeasure': 'percentage of complete questionnaires', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Care Partner Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'title': 'pre- to post-course', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-0.2'}]}]}, {'title': 'pre-course to follow-up', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using Zarit Burden Interview (ZBI-6). Total of 6 questions scored on a 5 point scale (0-4). The sum of the 6 questions in the total score. Range: 0-24. A higher score is indicative of greater caregiver burden. Change in control period compared to change in intervention period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'title': 'pre- to post-course', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.4'}]}]}, {'title': 'pre-course to follow-up', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using the Center for Epidemiological Studies Depression Scale (CES-D-10). Total of 10 questions scored on a categorical scale (0-3). The sum of the 10 questions is the total score. Range: 0-30. A total value above 10 is considered to be a sign of depression. A higher score represents a greater degree of depressed mood. Change in control period compared to change in intervention period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Self-compassion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'title': 'pre- to post-course', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.5'}]}]}, {'title': 'pre-course to follow-up', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using "The State Self-Compassion Scale Short Form." Uses a Likert-type scale ranging from 1 to 5. \\[Range: 12-60\\] Higher scores indicates more self compassion.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mindful Attention Awareness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'classes': [{'title': 'pre- to post-course', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.6'}]}]}, {'title': 'pre-course to follow-up', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using The 5-Item Mindful Attention Awareness Scale - State This is a 5-item scale to indicate at what level they relate to specific experiences, aimed at measuring main characteristics of mindfulness: (scale is 0-"not at all" to 6-"very much"). \\[Range: 0-30\\] Higher scores indicate elevated levels of mindfulness expression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from 3 health care systems in Minnesota, California, and Michigan. Information about the program was shared by clinicians during scheduled visits. Site-specific fliers were posted in public spaces and on institutional websites. A bulk mailing of MBDC fliers targeting non-white/Hispanic Minnesotans with MCI or or dementia was sent. Additionally, a new MBDC instructor was trained recruited an in-person cohort of CPs from her predominately African American Church.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MBDC Course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.\n\nMindfulness-Based Dementia Caregiving: Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Unknown/Not Reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': '8th grade or less', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Some high school', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'High school diploma or GED', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Technical training or Associate degree', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Some college', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'College degree', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Graduate studies', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Occupation', 'classes': [{'categories': [{'title': 'Employed for wages', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Self-employed', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Out of work for 1 year or more', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Out of work for less than 1 year', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'A homemaker', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'A student', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Retired', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'Unable to work', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-19', 'size': 895939, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-07T17:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2022-11-07', 'resultsFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-25', 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Self-compassion', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using "The State Self-Compassion Scale Short Form." Uses a Likert-type scale ranging from 1 to 5. \\[Range: 12-60\\] Higher scores indicates more self compassion.'}, {'measure': 'Change in Mindful Attention Awareness', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using The 5-Item Mindful Attention Awareness Scale - State This is a 5-item scale to indicate at what level they relate to specific experiences, aimed at measuring main characteristics of mindfulness: (scale is 0-"not at all" to 6-"very much"). \\[Range: 0-30\\] Higher scores indicate elevated levels of mindfulness expression.'}], 'primaryOutcomes': [{'measure': 'Participation Rate', 'timeFrame': 'Baseline', 'description': 'Number of the participants who attend the first class of their session. Enrolled is defined as a participant who is assigned to a course. Range \\[0-124\\]. A value closer to 124 is indicative of greater feasibility.'}, {'measure': 'Completion Rate', 'timeFrame': '16 weeks', 'description': 'Percent of the participants who completed courses. Completion is defined as attending a minimum of 6 of the 9 classes. Range \\[0-100\\]. A value closer to 100 is indicative of greater feasibility.'}, {'measure': 'Questionnaire Specific Response Rate', 'timeFrame': '16 weeks', 'description': 'Completeness of questionnaires given over the course of the study. Completeness is defined percent of complete questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Change in Care Partner Burden', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using Zarit Burden Interview (ZBI-6). Total of 6 questions scored on a 5 point scale (0-4). The sum of the 6 questions in the total score. Range: 0-24. A higher score is indicative of greater caregiver burden. Change in control period compared to change in intervention period.'}, {'measure': 'Change in Symptoms of Depression', 'timeFrame': 'baseline, post-course at 8 weeks, follow-up at 20 weeks', 'description': 'Measured using the Center for Epidemiological Studies Depression Scale (CES-D-10). Total of 10 questions scored on a categorical scale (0-3). The sum of the 10 questions is the total score. Range: 0-30. A total value above 10 is considered to be a sign of depression. A higher score represents a greater degree of depressed mood. Change in control period compared to change in intervention period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregivers', 'Mindfulness'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility, acceptability, and fidelity of implementation of the Mindfulness Based Dementia Care (MBDC) program to reduce depressive symptoms in care partners (CPs) of people living with dementia (PLWD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Self-identify as being an informal CP providing caregiving to a PLWD\n* Register for an MBDC course through the Presence Care Website\n\nExclusion Criteria:\n\n* Previous participation in an MBDC program.\n* Does not speak and understand either English or Spanish.'}, 'identificationModule': {'nctId': 'NCT05617300', 'briefTitle': 'Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms', 'orgStudyIdInfo': {'id': 'A21-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBDC course', 'description': '8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.', 'interventionNames': ['Behavioral: Mindfulness-Based Dementia Caregiving']}], 'interventions': [{'name': 'Mindfulness-Based Dementia Caregiving', 'type': 'BEHAVIORAL', 'description': 'Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.', 'armGroupLabels': ['MBDC course']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Leah R Hanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}