Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04165005
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2019-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019018', 'term': 'Imagery, Psychotherapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simon task- change from baseline to after intervention', 'timeFrame': "at baseline and through intervention's completion, 10 weeks.", 'description': 'a cognitive task, assessing control processes under speeded conditions, measured by response time and accuracy rate. shorter response time and higher accuracy rate indicate better performance.'}], 'secondaryOutcomes': [{'measure': 'FFMQ- change from baseline to after intervention', 'timeFrame': "at baseline and through intervention's completion, 10 weeks.", 'description': 'The Five-Fact Mindfulness Questionnaire, a manipulation check of mindfulness, ranging from 1 to 5, with higher score indicating higher mindfulness level'}, {'measure': 'PWB questionnaire- change from baseline to after intervention', 'timeFrame': "at baseline and through intervention's completion, 10 weeks.", 'description': 'The Psychological Well-Being Questionnaire, ranging from 1 to 6, with higher score indicating higher well-being level'}, {'measure': 'MMSE- change from baseline to after intervention', 'timeFrame': "at baseline and through intervention's completion, 10 weeks.", 'description': 'the Mini-Mental State examination: a cognitive function measure for elders, used to determine participation eligibility. the animation score ranges between 0 to 30, with higher score indicating better cognitive functioning'}, {'measure': 'PHQ-9- change from baseline to after intervention', 'timeFrame': "at baseline and through intervention's completion, 10 weeks.", 'description': 'The Patient Health Questionnaire - a depression levels measure, ranging from 0 to 3, with higher score indicating higher depression level'}, {'measure': 'BDI-II- change from baseline to after intervention', 'timeFrame': "at baseline and through intervention's completion, 10 weeks.", 'description': 'The Beck Depression Inventory-II- a depression levels measure, ranging from 1 to 4, with higher score indicating higher depression level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elderly', 'MBSR', 'cognitive functions', 'psychological status'], 'conditions': ['Old Age; Debility', 'Psychological Distress', 'Cognitive Change']}, 'referencesModule': {'references': [{'pmid': '36385638', 'type': 'DERIVED', 'citation': 'Aisenberg-Shafran D, Shturm L. The effects of mindfulness meditation versus CBT for anxiety on emotional distress and attitudes toward seeking mental health treatment: a semi-randomized trial. Sci Rep. 2022 Nov 16;12(1):19711. doi: 10.1038/s41598-022-24256-9.'}]}, 'descriptionModule': {'briefSummary': "The present study examined the effect of a short Mindfulness-based intervention emphasizing a 'decentering' component on elderly seniors. Methods: 30 community seniors (Mage= 74.7) performed either 'decentering' intervention, guided imagery intervention, or control care as usual. The 8-week interventions included weekly 20-minute sessions and daily 10-minute home practice. Participants underwent a cognitive and emotional assessment before and after the interventions, which included filling out questionnaires and performing the Simon task. Trial registration: The study follows the principles of the Declaration of Helsinki, approved by the committee in Beer-Yaacov Hospital, Israel (number 579) on 24 Oct. 2017."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 65 and above\n* membership in the study's specific enrollment community centers\n* scoring 24 and above in the Mini-Mental State Examination (MMSE).\n\nExclusion Criteria:\n\n* age under 65\n* not being a member in the study's specific enrollment community centers\n* scoring under 24 in the Mini-Mental State Examination (MMSE)."}, 'identificationModule': {'nctId': 'NCT04165005', 'briefTitle': 'Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress', 'organization': {'class': 'OTHER', 'fullName': 'Ben-Gurion University of the Negev'}, 'officialTitle': 'Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress', 'orgStudyIdInfo': {'id': '597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'decentering group', 'description': 'MBSR focused on a "decentering" component (i.e. individuals observe their feelings and thoughts as ephemeral events, with no reactivity, alongside with acceptance).', 'interventionNames': ['Behavioral: decentering']}, {'type': 'EXPERIMENTAL', 'label': 'guided imagery group', 'description': 'a group practicing in guided imagery sessions.', 'interventionNames': ['Behavioral: guided imagery']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'usual care group'}], 'interventions': [{'name': 'decentering', 'type': 'BEHAVIORAL', 'description': 'examined a mindfulness-based intervention focused on a decentering component, that is suitable for elders, aimed to influence on cognitive measures and psychological distress.', 'armGroupLabels': ['decentering group']}, {'name': 'guided imagery', 'type': 'BEHAVIORAL', 'description': 'relaxing guided imagery including breathing exercises.', 'armGroupLabels': ['guided imagery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4025000', 'city': 'Emek-Hefer', 'state': 'Emek-Hefer', 'country': 'Israel', 'facility': 'Ruppin Academic Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruppin Acdemic Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MA student, MA in the clinical-gerontological program, Ruppin Academic Center', 'investigatorFullName': 'Ophir Leshets', 'investigatorAffiliation': 'Ben-Gurion University of the Negev'}}}}