Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-03-22 @ 12:25 PM
Study NCT ID:
NCT03239132
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MEditation for Post Stroke Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility as assessed by number screened per week', 'timeFrame': '2 years'}, {'measure': 'Feasibility as assessed by proportion of those eligible who enroll to the study', 'timeFrame': '2 years'}, {'measure': 'Feasibility as assessed by number of participants who completed the study', 'timeFrame': '2 years'}, {'measure': 'Feasibility as assessed by number of participants who adhered to the protocol', 'timeFrame': '2 years'}, {'measure': 'Feasibility as assessed by number of participants who completed all study assessments', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Post-Stroke Depression as assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10)', 'timeFrame': 'baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends'}, {'measure': 'Post-Stroke Anxiety as assessed by the State-Trait Anxiety Inventory for Adults (STAI-AD)', 'timeFrame': 'baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends'}, {'measure': 'Levels of plasma IL-1 family pro-inflammatory cytokines', 'timeFrame': 'baseline, immediately after intervention ends, 4 weeks after intervention ends, 8 weeks after intervention ends'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Depression']}, 'referencesModule': {'references': [{'pmid': '36635775', 'type': 'DERIVED', 'citation': 'Beauchamp JES, Sharrief A, Chaoul A, Casameni Montiel T, Love MF, Cron S, Prossin A, Selvaraj S, Dishman D, Savitz SI. Feasibility of a meditation intervention for stroke survivors and informal caregivers: a randomized controlled trial. BMC Psychol. 2023 Jan 12;11(1):9. doi: 10.1186/s40359-022-01031-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (PSD) and their informal caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis is that the breath-based meditation will lead to decreases in the severity of symptoms of PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and their informal caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke survivors will be included if they speak English, can provide written informed consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack within the past 8 weeks, have a Center for Epidemiologic Studies-Depression (CES-D) total score of 16 or greater suggestive of clinically significant depressive symptoms, and currently live at home.\n* Informal caregivers will be included if they are speak English, can provide written informed consent, and self-identify as a first-time informal caregiver of a stroke survivor. -\n* To reflect standard practice, stroke survivors and their informal caregivers will be eligible to participate in the study regardless of whether they are currently receiving anti-depressant medications; however, the dose must have been stable for at least one month prior to recruitment into the study.\n\nExclusion Criteria:\n\n* Stroke survivors will be excluded if they currently reside outside of the home (e.g., rehabilitation center).\n* Stroke survivors and their informal caregivers will be excluded if they have severe cognitive impairment (Montreal Cognitive Assessment (MoCA) cutoff score of 20), active psychosis, or bipolar disorder; if they currently abuse substances; or if they are acutely suicidal. Those currently receiving formal psychotherapy or currently engaging in self-identified meditation practices will also be excluded.'}, 'identificationModule': {'nctId': 'NCT03239132', 'acronym': 'MEND', 'briefTitle': 'MEditation for Post Stroke Depression', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'MEditation for Post Stroke Depression', 'orgStudyIdInfo': {'id': 'HSC-SN-17-0583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breath-based meditation', 'description': 'The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks, as well as meditation educational materials.', 'interventionNames': ['Behavioral: Breath-based meditation', 'Behavioral: Meditation educational materials']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control will receive meditation educational materials.', 'interventionNames': ['Behavioral: Meditation educational materials']}], 'interventions': [{'name': 'Breath-based meditation', 'type': 'BEHAVIORAL', 'description': 'The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.', 'armGroupLabels': ['Breath-based meditation']}, {'name': 'Meditation educational materials', 'type': 'BEHAVIORAL', 'description': 'Meditation educational materials', 'armGroupLabels': ['Breath-based meditation', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jennifer E Sanner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Beauchamp', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}