Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT03982316
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2019-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telehealth Behavioral Migraine Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-23'}], 'estimatedResultsFirstSubmitDate': '2025-12-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2019-06-08', 'studyFirstSubmitQcDate': '2019-06-08', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of TeleBMM', 'timeFrame': 'Week 0 through Week 12', 'description': 'Number of treatment components participants complete (out of 20)'}], 'secondaryOutcomes': [{'measure': 'Patient-rated satisfaction', 'timeFrame': 'Post-treatment survey at Week 12', 'description': 'Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied")'}, {'measure': 'Quality of Life (Migraine Specific)', 'timeFrame': 'Change from Pre-treatment (Week 0) to Post-treatment (Week 12)', 'description': 'Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine.'}, {'measure': 'Headache frequency', 'timeFrame': 'Slope change from Week 0 to Week 12', 'description': 'Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral MIgraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of migraine\n* Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine\n* Self-reported between 4 and 20 headache days/month\n* Aged 18-65\n* Can read English\n* Capacity to consent\n\nExclusion Criteria:\n\n* Psychiatric illness that would interfere with study participation\n* Meeting criteria for probable medication overuse headache'}, 'identificationModule': {'nctId': 'NCT03982316', 'acronym': 'TeleBMM', 'briefTitle': 'Telehealth Behavioral Migraine Management', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Telehealth Behavioral Migraine Management', 'orgStudyIdInfo': {'id': '2019-10345'}, 'secondaryIdInfos': [{'id': 'UL1TR002556', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002556', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth Behavioral Migraine Management', 'description': 'Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.', 'interventionNames': ['Behavioral: Telehealth Behavioral Migraine Management']}], 'interventions': [{'name': 'Telehealth Behavioral Migraine Management', 'type': 'BEHAVIORAL', 'description': '1\\) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.', 'armGroupLabels': ['Telehealth Behavioral Migraine Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Elizabeth K Seng, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeshiva University/Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}