Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-26 @ 9:11 AM
Study NCT ID:
NCT00462150
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-16', 'studyFirstSubmitDate': '2007-04-16', 'studyFirstSubmitQcDate': '2007-04-16', 'lastUpdatePostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressed mood.'}, {'measure': 'Cheerful mood.'}, {'measure': 'Both measures at baseline, 1 week after intervention, and 3 months after intervention.'}], 'secondaryOutcomes': [{'measure': 'Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the intervention).'}, {'measure': 'Induction of core elements: immediate negative affect change, emotion, insight, and optimism word use during the intervention.'}, {'measure': 'Clinical measures: Joint score; Erythrocyte Sedimentation Rate; both measures at baseline, 1 week after intervention, and 3 months after intervention.'}, {'measure': 'Physiological measures: 24-h Urinary cortisol; 24-h Urinary noradrenaline; IL-6; IFN-γ; IL-10; all measures at baseline, 1 week after intervention, and 3 months after intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arthritis, rheumatoid', 'expressed emotion', 'randomized controlled trial', 'affect', 'blood sedimentation', 'psychophysiology', 'feasibility studies', 'intervention studies', 'time management'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '17336025', 'type': 'RESULT', 'citation': 'van Middendorp H, Sorbi MJ, van Doornen LJ, Bijlsma JW, Geenen R. Feasibility and induced cognitive-emotional change of an emotional disclosure intervention adapted for home application. Patient Educ Couns. 2007 May;66(2):177-87. doi: 10.1016/j.pec.2006.11.009. Epub 2007 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is threefold: 1) to develop a home-based emotional disclosure intervention inducing core elements of change (emotional engagement, cognitive restructuring, and positive future directedness); 2) to examine in a randomized controlled trial in patients with rheumatoid arthritis the induction of the core elements and the feasibility of the intervention for home application; and, 3) to examine the psychological, clinical, and physiological effects of the adapted emotional disclosure intervention and the modulating role of cognitive-emotional change and individual differences in emotion regulation.', 'detailedDescription': 'Emotional disclosure has been suggested to alleviate psychological and physical stress in chronically ill people. Emotional engagement, cognitive restructuring, and positive future directedness are considered core elements to induce change in emotional disclosure interventions. The aim of our randomized controlled trial in patients with rheumatoid arthritis is to examine the psychological, clinical, and physiological effects of an emotional disclosure intervention adapted for home application and the modulating role of cognitive-emotional change and individual differences in emotion regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of rheumatoid arthritis according to the criteria of the American College of Rheumatology (Arthritis Rheum 1988;31:315-24\n* Written informed consent'}, 'identificationModule': {'nctId': 'NCT00462150', 'briefTitle': 'Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)', 'orgStudyIdInfo': {'id': 'NR 99-1-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'home-based emotional disclosure', 'type': 'BEHAVIORAL'}, {'name': 'time management control condition', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 80.140, 3508 TC', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht University, Department of Clinical and Health Psychology', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Henriët van Middendorp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utrecht University, Department of Clinical and Health Psychology'}, {'name': 'Rinie Geenen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Utrecht University, Department of Clinical and Health Psychology'}, {'name': 'Johannes WJ Bijlsma, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}}}}