Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-01-13 @ 12:34 PM
Study NCT ID:
NCT01694628
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': '8 weeks', 'description': 'Personal Health Questionnaire-9'}], 'secondaryOutcomes': [{'measure': 'Dyspnea Intensity and Distress', 'timeFrame': '8 weeks', 'description': 'Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire'}, {'measure': 'Fatigue', 'timeFrame': '8 weeks', 'description': 'Chronic Respiratory Questionnaire'}, {'measure': 'Anxiety', 'timeFrame': '8 weeks', 'description': 'Hospital Anxiety and Depression Scale'}, {'measure': 'Physical Activity', 'timeFrame': '8 weeks', 'description': 'Accelerometry (Stepwatch)'}, {'measure': 'Quality of Life', 'timeFrame': '8 weeks', 'description': 'Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study in patients with advanced COPD and depression is twofold:\n\n1. Determine the feasibility and acceptability of a 6-session e-counseling intervention\n2. Determine the efficacy of the e-counseling intervention on depressive symptoms\n\nWe hypothesize that patients who participate in e-counseling will have improved depressive symptoms compared to patients receiving usual care at 8 weeks.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD is primarily focused on symptom palliation with the goal of improving quality of life for both patients and their families. These goals are highly consistent with core principles of palliative care. Dyspnea is the most distressing symptom for patients. Even optimal disease-directed treatment provides only partial relief from dyspnea. Depression is consistently associated with worse dyspnea, but the mechanisms underlying this relationship are poorly understood. Since existing treatment for dyspnea has only limited success and there is evidence that treating depression alleviates pain, we propose that by improving mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT) which is focused on increasing pleasant events and improving problem solving skills has been shown to have immediate and sustained effects on depressive symptoms in patients with dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the use of novel technologies to provide efficacious interventions such as PBT to patients with advanced disease is critical for translational palliative care research'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* COPD (FEV1/FVC \\< 70% \\& FEV1 \\<80%; current or past smoking \\>10pack-years)\n* Depressed (PHQ-9 \\>=10)\n* Ability to speak, read and write English\n* Willingness to use computer or study-issued tablet device\n\nExclusion Criteria:\n\n* Current non-nicotine substance abuse or dependence\n* Psychotic disorder\n* Active suicide ideation with intent and plan\n* Alzheimer's/dementia\n* Currently receiving any psychotherapy"}, 'identificationModule': {'nctId': 'NCT01694628', 'acronym': 'CLIMB', 'briefTitle': 'Cognitive Behavioral Therapy for COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression', 'orgStudyIdInfo': {'id': '43252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLIMB (COPD Lifestyle, Mood, and Behavior)', 'description': 'Counseling sessions for COPD and depression', 'interventionNames': ['Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual Care'}], 'interventions': [{'name': 'CLIMB (COPD Lifestyle, Mood, and Behavior)', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.', 'armGroupLabels': ['CLIMB (COPD Lifestyle, Mood, and Behavior)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lynn F Reinke, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Lynn Foster Reinke', 'investigatorAffiliation': 'University of Washington'}}}}