Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:00 AM
Study NCT ID:
NCT07491861
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a waitlist control design where an immediate start arm receives the intervention immediately, and a delayed start arm receives the intervention approximately 8 weeks later.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of MBSR Intervention Feasibility by measuring class attendance', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'Feasibility of the MBSR intervention will be assessed by measuring attendance of the sessions'}, {'measure': 'Assessment of MBSR Intervention Feasibility through item 4 of the CSQ-8', 'timeFrame': 'From pre-intervention visit to end of treatment (~8 weeks)', 'description': 'Satisfaction with the course will be measured using item 4 of the CSQ-8, which asks whether the participant would recommend the course to others.'}, {'measure': 'Assessment of Study Feasibility through measurement of participant recruitment', 'timeFrame': '3-month recruitment period', 'description': 'Recruitment feasibility will be assessed by measuring the number of participants recruited within the 3-month recruitment window compared to the recruitment goals of the study.'}, {'measure': 'Assessment of Study Feasibility through measurement of participant study completion (retention)', 'timeFrame': 'From enrollment to end of study (approximately 16 weeks)', 'description': 'Retention will be measured by assessing number of recruited participants who complete all study visits.'}], 'secondaryOutcomes': [{'measure': 'Improvement of Interoception as assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA)', 'timeFrame': 'From pre-intervention visit to end of treatment (~8 weeks)', 'description': 'Higher scores indicate greater interoceptive awareness'}, {'measure': 'Assessment of Interoception using the Body Perception Questionnaire short form (BPQ-SF)', 'timeFrame': 'From pre-intervention visit to end of treatment (~8 weeks)', 'description': 'Higher scores indicate more symptoms'}, {'measure': 'Assessment of Emotional Wellbeing through the Personal Health Questionnaire 8-item (PHQ-8)', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'Higher scores indicate more severe depression'}, {'measure': 'Assessment of Emotional Wellbeing using the Generalized Anxiety Disorder 7-item (GAD-7)', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'Higher scores indicate more severe anxiety'}, {'measure': 'Assessment of Emotional Well-being using the World Health Organization Wellbeing Index (WHO-5)', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'A higher score indicates better mental well-being'}, {'measure': 'Assessment of Emotional Well-being using the Satisfaction with Life Scale (SWLS)', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'A higher score indicates greater satisfaction'}, {'measure': 'Assessment of Emotional Wellbeing through the Meaning in Life Questionnaire-Presence', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'The 5-item presence subscale of the Meaning in Life Questionnaire measures the degree to which individuals feel their lives are full of meaning and purpose. A higher score indicates stronger levels of perceived meaning.'}, {'measure': 'Assessment of Whole Person Health using the Whole Person Health Index (WPHI)', 'timeFrame': 'From pre-intervention visit to the end of treatment (~8 weeks)', 'description': 'A higher score indicates better or improving health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'MBSR', 'Chronic Stroke', 'Interoception'], 'conditions': ['Chronic Stroke Patients']}, 'descriptionModule': {'briefSummary': "The goal of this pilot study is to examine the feasibility, acceptability, and preliminary effects of mindfulness-based stress reduction (MBSR) on interoception (your understanding of your body's internal senses), emotional well-being, and whole person health. A total of 30 people with chronic stroke will be enrolled in this study to participate in an MBSR course, consisting of a 30-minute intake visit, 8 sessions lasting 2.5 hours plus a 1-day 7-hour retreat. Participants will be randomized into either the first MBSR course (immediate start) or the second MBSR course (delayed start/waitlist control)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to consent to study participation\n* Age 18+\n* Diagnosis of stroke ≥6 months prior to enrollment\n* A score of 5 or more on the Kessler Psychological Distress Scale (K6)\n* Reliable and consistent internet access and a device with video conferencing (e.g. Zoom) capabilities (e.g., smart phone, tablet, or laptop/computer) for the duration of the study\n* Able to attend an 8-week mindfulness course on Friday afternoons, starting approximately in mid-May or mid-July\n\nExclusion Criteria:\n\n* Non-English speaking\n* Prior completion of an MBSR course\n* Active participation or past participation ≤3 months in any other interventional research study\n* History of any serious/uncontrolled neurological, psychiatric, or substance use disorder that would impact study participation\n* Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT07491861', 'briefTitle': 'Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Interoception and Emotional Recovery After Stroke: A Pilot Study of Mindfulness-Based Stress Reduction', 'orgStudyIdInfo': {'id': 'A26-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Immediate Start', 'description': 'Individuals in the immediate start arm will receive the intervention (MBSR course) immediately upon enrolling, followed by an 8-week post intervention follow-up period.', 'interventionNames': ['Behavioral: Mindfulness-Based Stress Reduction (MBSR)']}, {'type': 'OTHER', 'label': 'Delayed Start (Waitlist Control)', 'description': 'Individuals in the delayed start arm will be waitlisted for approximately 8 weeks upon enrolling, followed by the MBSR course for an additional 8 weeks after the delay.', 'interventionNames': ['Behavioral: Mindfulness-Based Stress Reduction (MBSR)']}], 'interventions': [{'name': 'Mindfulness-Based Stress Reduction (MBSR)', 'type': 'BEHAVIORAL', 'description': 'MBSR consists of teaching meditation practices through breath and body awarness, awareness of movement through Yoga postures, and psychoeducation on stress reduction. The course will be offered online through video conferencing and will consist of a 30-minute intake visit, 8 weekly 2.5-hour sessions, and a 7-hour retreat.', 'armGroupLabels': ['Delayed Start (Waitlist Control)', 'Immediate Start']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Meghan O'Brien, MPH", 'role': 'CONTACT', 'email': 'Meghan.E.Obrien@HealthPartners.com', 'phone': '651-493-6363'}, {'name': 'Bethany Crouse, PhD', 'role': 'CONTACT', 'email': 'Bethany.K.Crouse@HealthPartners.com'}, {'name': 'Amanda Herrmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'centralContacts': [{'name': "Meghan O'Brien, MPH", 'role': 'CONTACT', 'email': 'Meghan.E.Obrien@HealthPartners.com', 'phone': '651-495-6363'}, {'name': 'Bethany Crouse, PhD', 'role': 'CONTACT', 'email': 'bethany.k.crouse@healthpartners.com'}], 'overallOfficials': [{'name': 'Amanda Herrmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}