Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-03-19 @ 7:47 AM
Study NCT ID:
NCT03313466
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2017-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016477', 'term': 'Artifacts'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days supply of dispensed insomnia medications', 'timeFrame': 'One year', 'description': 'Days supply of dispensed insomnia medications up to one year after randomization.'}], 'secondaryOutcomes': [{'measure': 'Health care inpatient and outpatient encounters', 'timeFrame': 'One year', 'description': 'Number of physician or mid-level provider encounters (face-to-face, telephone, video): (1) outpatient, (2) acute care: emergency, inpatient, up to one year after randomization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '33908343', 'type': 'DERIVED', 'citation': 'Derose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021 Aug 1;17(8):1675-1684. doi: 10.5664/jcsm.9280.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A prescription for any of a set of selected insomnia medications.\n* Age \\>18 years at the time of the prescription.\n* A recent (\\<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.\n* Membership for \\>365 days prior to the prescription date.\n* No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.\n\nExclusion Criteria:\n\n* Contained in inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03313466', 'briefTitle': 'Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications', 'orgStudyIdInfo': {'id': '11262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iCBTI', 'description': "Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions.", 'interventionNames': ['Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.', 'interventionNames': ['Behavioral: Class in sleeping well and improving insomnia']}], 'interventions': [{'name': 'Internet cognitive behavioral therapy for insomnia (iCBTI)', 'type': 'BEHAVIORAL', 'description': 'An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.', 'armGroupLabels': ['iCBTI']}, {'name': 'Class in sleeping well and improving insomnia', 'type': 'BEHAVIORAL', 'description': 'A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Stephen Derose, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Big Health Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}