Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-09 @ 5:38 AM
Study NCT ID:
NCT03922867
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based CBT for Insomnia Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in insomnia severity', 'timeFrame': 'through study completion, an average of 12 weeks', 'description': 'Surveying the changes in insomnia severity seen during the subjects participation in the study'}, {'measure': 'Change in attitude towards sleep', 'timeFrame': 'through study completion, an average of 12 weeks', 'description': 'Surveying the subjects attitude towards sleep over the duration of their participation in the study.'}], 'secondaryOutcomes': [{'measure': 'Change in fibromyalgia symptoms', 'timeFrame': 'through study completion, an average of 12 weeks', 'description': 'Surveying the change in fibromyalgia symptoms that occur during study participation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insomnia', 'fibromyalgia'], 'conditions': ['Insomnia', 'Fibromyalgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.', 'detailedDescription': 'The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets diagnostic criteria for fibromyalgia\n* Has insomnia\n* Have internet access and a device that can access the web-based program.\n\nExclusion Criteria:\n\n* Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome)\n* Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.\n* Chronic fatigue syndrome\n* Morbid obesity'}, 'identificationModule': {'nctId': 'NCT03922867', 'briefTitle': 'Web-based CBT for Insomnia Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': '18-011637'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Subjects with receive standard of care for management of insomnia in subjects with fibromyalgia'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'Subjects will receive standard of care and additionally complete the online cognitive behavior therapy program', 'interventionNames': ['Behavioral: CBT']}], 'interventions': [{'name': 'CBT', 'type': 'BEHAVIORAL', 'description': 'A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ravindra Ganesh, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Sanjeev Nanda, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ravindra Ganesh', 'investigatorAffiliation': 'Mayo Clinic'}}}}