Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-05 @ 8:00 PM
Study NCT ID:
NCT00251420
Status:
COMPLETED
Last Update Posted:
2009-05-07
First Post:
2005-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Writing About Disease: Effect on Rehabilitation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}], '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': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-06', 'studyFirstSubmitDate': '2005-11-09', 'studyFirstSubmitQcDate': '2005-11-09', 'lastUpdatePostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'prospective'}, {'measure': 'Perceived health status', 'timeFrame': 'prospective'}, {'measure': 'Trait anxiety', 'timeFrame': 'prospective'}], 'secondaryOutcomes': [{'measure': 'Forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'prospective'}, {'measure': '6-minute walking distance', 'timeFrame': 'prospective'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['copd', 'asthma', 'QoL', 'Perceived health status', 'Trait anxiety'], 'conditions': ['COPD', 'Asthma']}, 'descriptionModule': {'briefSummary': "Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life, and perceived health status.", 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions:\n\n* Writing about emotional consequences of their disease before the program starts\n* Writing about physical consequences of their disease before the program starts\n* Not writing\n\nAll patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program.\n\nIn addition to questionnaires, all patients are asked to:\n\n* Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and\n* Write in their own words (6 months after) about how the disease affects their life at that point.\n\nBoth quantitative and qualitative data will be used for analysis purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of COPD (age between 35 and 70)\n* Clinical diagnosis of asthma (age between 20 and 60)'}, 'identificationModule': {'nctId': 'NCT00251420', 'briefTitle': 'Writing About Disease: Effect on Rehabilitation?', 'organization': {'class': 'OTHER', 'fullName': 'LHL Helse'}, 'officialTitle': 'Writing About Disease: Effect on Rehabilitation?', 'orgStudyIdInfo': {'id': 'G22-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'writing about disease', 'type': 'PROCEDURE', 'description': 'writing about physical or emotional consequences of pulmonary disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1485', 'city': 'Hakadal', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Glittreklinikken', 'geoPoint': {'lat': 60.12146, 'lon': 10.82399}}], 'overallOfficials': [{'name': 'Einar Haave, Cand Psychol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LHL Helse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LHL Helse', 'class': 'OTHER'}, 'collaborators': [{'name': 'The norwegian association for heart and lung patients', 'class': 'UNKNOWN'}]}}}