Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-02 @ 2:30 AM
Study NCT ID:
NCT01072292
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2010-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-01', 'studyFirstSubmitDate': '2010-02-18', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep quality', 'timeFrame': '6-8 weeks'}], 'secondaryOutcomes': [{'measure': 'fatigue/tiredness, using the Chronic Respiratory Disease Questionnaire', 'timeFrame': '6-8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '22162648', 'type': 'RESULT', 'citation': 'Kapella MC, Herdegen JJ, Perlis ML, Shaver JL, Larson JL, Law JA, Carley DW. Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. Int J Chron Obstruct Pulmon Dis. 2011;6:625-35. doi: 10.2147/COPD.S24858. Epub 2011 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'A two-phase research study is being conducted. In Phase 1 of the study, the cognitive behavioral therapy intervention for insomnia was implemented in a small (n = 5) group of people with moderate to severe COPD and insomnia. The intervention was pilot-tested to determine feasibility and acceptability, and the intervention will be refined as needed. In Phase 2 of the study, a two-group randomized controlled study (n = 20) will be conducted to test the effects of the cognitive behavioral therapy for insomnia intervention on the primary outcomes of sleep quality and fatigue and the secondary outcomes of mood and functional performance. It is hypothesized that people with COPD receiving cognitive behavioral therapy for insomnia will demonstrate significant improvements in sleep quality, fatigue, mood and functional performance as compared to people with COPD who receive a wellness program. This research will yield valuable information regarding effective interventions aimed at mitigating problems such as poor sleep quality, fatigue and reduced ability to perform valued daily activities. This information will be used to increase the likelihood of long-term successful outcomes such as the ability to maintain productive roles in society for people with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will have moderate to severe COPD. Severity of COPD will be defined according to the new GOLD standards (moderate IIA (moderate), 50% \\< FEV1 \\< 80% predicted; moderate IIB (severe) 30% \\< FEV1 \\< 50%). 58\n* Insomnia. Insomnia will be defined as difficulty initiating or maintaining sleep, waking up too early or poor quality sleep. 59\n* Subjects must be \\> 45 years of age with no other major health problems\n* Subjects must be clinically stable at the time of enrollment into the study without major exacerbation of COPD within the previous two months.\n\nExclusion Criteria:\n\n* Evidence of restrictive lung disease or asthma.\n* Evidence of a major sleep disorder other than insomnia (sleep apnea evidenced by apnea/hypopnea index of \\> 10, periodic limb movement disorder, narcolepsy).\n* Hypnotic, sedative, anxiolytic or antidepressant use.\n* Pulse oximetry (SaO2) reading of \\< 90% at rest.\n* Pulse oximetry (SaO2) reading of \\< 85% at night for \\> 5 minutes.\n* Significant sleep apnea (apnea/hypopnea index ≥ 10).\n* .Acute respiratory infection within the previous 2 months.\n* Class \\> 2 functional status according to the New York Heart Association.\n* The presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.\n* A self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of \\> 11.\n* Currently participating in pulmonary rehabilitation.'}, 'identificationModule': {'nctId': 'NCT01072292', 'briefTitle': 'Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Nurse Managed Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'KO1 NR010749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-I', 'description': 'CBT-I', 'interventionNames': ['Behavioral: CBT-I']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wellness Education', 'description': 'Wellness Education', 'interventionNames': ['Behavioral: CBT-I']}], 'interventions': [{'name': 'CBT-I', 'type': 'BEHAVIORAL', 'description': 'CBT-I is a six week program designed to improve sleep quality in people with COPD.', 'armGroupLabels': ['CBT-I', 'Wellness Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Mary C Kapella, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mary C. Kapella', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}