Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT00911794
Status:
COMPLETED
Last Update Posted:
2009-06-02
First Post:
2009-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-01', 'studyFirstSubmitDate': '2009-05-29', 'studyFirstSubmitQcDate': '2009-06-01', 'lastUpdatePostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea and quality of life', 'timeFrame': 'Two-month and six-month time'}], 'secondaryOutcomes': [{'measure': 'Six-minute walk distance', 'timeFrame': 'Two-month and six-month time'}, {'measure': 'Spirometry values (FEV1 and FVC)', 'timeFrame': 'Two-month and six-month time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyspnea', 'Written Disclosure Therapy', 'COPD', 'Pulmonary Fibrosis', 'Chronic Lung Diseases', 'Pulmonary Rehabilitation'], 'conditions': ['Chronic Lung Diseases', 'COPD', 'Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any benefit to patients with chronic lung diseases who are participating in pulmonary rehabilitation.', 'detailedDescription': 'Chronic lung diseases are typically associated with impaired quality of life, stress, and anxiety. Written disclosure therapy (WDT) reduces stress in patients with a variety of chronic illnesses. We sought to determine if written disclosure therapy benefits patients with chronic lung diseases when it is added as a component to the pulmonary rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD or Pulmonary Fibrosis\n* First time participants in Pulmonary Rehabilitation program\n\nExclusion Criteria:\n\n* Dementia\n* Prior significant psychiatric illness\n* Inability to complete the questionnaires\n* Inability cooperate with spirometry\n* Inability or to participate in outpatient follow-up over the six-month'}, 'identificationModule': {'nctId': 'NCT00911794', 'briefTitle': 'Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Winthrop University Hospital'}, 'officialTitle': 'Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease', 'orgStudyIdInfo': {'id': '07300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Written Disclosure Therapy', 'interventionNames': ['Other: Disclosure Writing (Written Disclosure Therapy)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Controls', 'interventionNames': ['Other: Neutral (Sham) Writing']}], 'interventions': [{'name': 'Disclosure Writing (Written Disclosure Therapy)', 'type': 'OTHER', 'otherNames': ['Written Disclosure Therapy'], 'description': 'Patients write about a stressful life experience', 'armGroupLabels': ['Written Disclosure Therapy']}, {'name': 'Neutral (Sham) Writing', 'type': 'OTHER', 'otherNames': ['Sham Writing (Controls that wrote about neutral subjects)'], 'description': 'Patients write about neutral subjects', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adam Hurewitz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Winthrop University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stony Wold-Herbert Fund, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Adam Hurewitz M.D.', 'oldOrganization': 'Winthrop University Hospital'}}}}