Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-12 @ 2:46 PM
Study NCT ID:
NCT03002402
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-20', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia severity', 'timeFrame': 'baseline and post-intervention (up to 9 weeks)', 'description': 'Insomnia Severity Index'}, {'measure': 'Asthma control', 'timeFrame': 'baseline and post-intervention (up to 9 weeks)', 'description': 'Asthma Control Test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'insomnia', 'cognitive-behavioral treatment'], 'conditions': ['Asthma', 'Insomnia Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study are to explore changes in sleep and asthma outcomes from baseline to post-treatment in adults with asthma and comorbid insomnia who underwent Internet-based cognitive-behavioral treatment for insomnia (CBT-I).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of moderate-severe persistent asthma\n* Not well controlled asthma (score ≤ 19 on the Asthma Control Test)\n* Age 18-75 years\n* Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder\n* At least moderate insomnia severity (score ≥ 10 on Insomnia Severity Index)\n* Telephone number, email address, and reliable Internet access\n\nExclusion Criteria:\n\n* History of bipolar or psychosis\n* Substance abuse disorder within past 3 months\n* Dementia or probable dementia diagnosis\n* Plans to move or leave present source of care during the following 6 months.\n* Non-English speaking, illiterate, or possesses sensory deficits'}, 'identificationModule': {'nctId': 'NCT03002402', 'briefTitle': 'Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma', 'orgStudyIdInfo': {'id': '1R03HL135213-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03HL135213-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R03HL135213-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03HL135213-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based CBT-I', 'description': 'Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of cognitive-behavioral treatment for insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is allocated out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a sleep restriction window).', 'interventionNames': ['Behavioral: Internet-based CBT-I']}], 'interventions': [{'name': 'Internet-based CBT-I', 'type': 'BEHAVIORAL', 'otherNames': ['Sleep Healthy Using the Internet (SHUTi)'], 'description': 'Internet-based cognitive-behavioral treatment for insomnia', 'armGroupLabels': ['Internet-based CBT-I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Faith S Luyster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Faith Luyster', 'investigatorAffiliation': 'University of Pittsburgh'}}}}