Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 1:09 PM
Study NCT ID:
NCT05595850
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2022-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mindful Community for People With ALS and Their Primary Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-13', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-10-22', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS)', 'timeFrame': '3 months', 'description': 'The ALSSQOL-SF is a 20 item quality of life instrument for patients. It has a 0-10 rating scale with higher scores denoting higher QOL.'}, {'measure': 'World Health Organization Quality of Life (Brief) WHO-QoL BREF - For Caregivers of PALS', 'timeFrame': '3 months', 'description': 'The WHO-QoL BREF is a 26 item quality of life scale covering four domains of QOL. Each item is scored from 1-5 with higher response employing a higher quality of life. Items are scored from 1-5'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '3 weeks, 3 months, 6 months after joining', 'description': 'The HADS measures anxiety and depression in a general medical population of patients. It has seven items each for depression and anxiety sub scales. Scoring ranges from 0 to 3, with 3 denoting the highest anxiety or depression level. A total sub scale score of over 8 out of 21 denotes considerable symptoms of either.'}, {'measure': 'Functional Status', 'timeFrame': '3 weeks, 3 months, 6 months after joining', 'description': 'Self-Administered Functional Rating Scale Revised'}, {'measure': 'Zarit Burden Interview', 'timeFrame': '3 weeks, 3 months, 6 months after joining', 'description': 'The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more has been considered high burden.'}, {'measure': 'ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF)', 'timeFrame': '3 weeks, 3 months, 6 months after joining', 'description': 'The ALSSQOL-SF is a 20 item quality of life instrument for patients. It has a 0-10 rating scale with higher scores denoting higher QOL.'}, {'measure': 'World Health Organization Quality of Life (Brief) WHO-QoL BREF', 'timeFrame': '3 weeks, 3 months, 6 months after joining', 'description': 'The WHO-QoL BREF is a 16 item quality of life scale covering four domains of QOL. Each item is scored from 1-5 with higher response employing a higher quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Quality of Life'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Caregiver Burden']}, 'descriptionModule': {'briefSummary': 'The psychological impact of ALS on patients and caregivers is high, significantly affecting their quality of life (QOL). Despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve QOL.\n\nThe efficacy of mindfulness-based treatments for the improvement of QOL was previously demonstrated by the investigator\'s group. Despite preliminary positive results, treatment efficacy tends to weaken over time. The investigators believe that a robust solution to maintain efficacy is to maximize the utilization of technology and emerging social platforms, establishing a "mindful community" to promote and continuously reinforce mindfulness.\n\nThis project\'s primary aims are 1) to develop a "mindful" online community of people with ALS and their caregivers, and 2) to test its efficacy in QOL improvement. This two-part intervention consists of 1) optimizing the investigator\'s prior e-learning platform with a three-week program including cognitive exercises, videos and lectures to increase participants\' mindfulness; and 2) involving participants in a "mindfulness community" within a social sharing forum. Assessments will be performed before and immediately post-treatment as well as 3- and 6-months post-program comparing subjects undergoing the intervention to a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the ALS patients\n\n* a definite, probable, laboratory-supported, or possible ALS by revised El-Escorial criteria\n* they must have the physical ability, with or without adaptive devices, to use a smartphone, a tablet, or a computer\n* have access to the Internet.\n\nFor the caregivers\n\n* be the person who resides with the ALS patient and is the major provider of unpaid care and assistance (typically, the spouse or another close relative)\n* s/he must be able to use the application\n* have access to the Internet.\n\nExclusion criteria\n\n\\- Using shared devices. Patients and caregivers should have their own devices.'}, 'identificationModule': {'nctId': 'NCT05595850', 'briefTitle': 'A Mindful Community for People With ALS and Their Primary Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Harvard University'}, 'officialTitle': 'A Mindful Community for People With ALS and Their Primary Caregivers', 'orgStudyIdInfo': {'id': 'IRB20-0629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'description': 'Three-week online mindfulness course followed by one-month social community online interaction.', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindful Learning', 'description': 'Three-week online mindful learning course followed by one-month social community online interaction', 'interventionNames': ['Behavioral: Mindful Learning']}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Online non-meditation mindfulness program', 'armGroupLabels': ['Mindfulness']}, {'name': 'Mindful Learning', 'type': 'BEHAVIORAL', 'description': 'Online learning program', 'armGroupLabels': ['Mindful Learning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Harvard University', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'centralContacts': [{'name': 'Deborah R Phillips, PhD', 'role': 'CONTACT', 'email': 'dphillips@fas.harvard.edu', 'phone': '9739027938'}, {'name': 'Francesco Pagnini, PhD', 'role': 'CONTACT', 'email': 'francesco.pagnini@unicatt.it'}], 'overallOfficials': [{'name': 'Ellen Langer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard U'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ellen Langer', 'investigatorAffiliation': 'Harvard University'}}}}