Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-04 @ 7:03 AM
Study NCT ID:
NCT00550966
Status:
UNKNOWN
Last Update Posted:
2007-10-30
First Post:
2007-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-10-29', 'studyFirstSubmitDate': '2007-10-29', 'studyFirstSubmitQcDate': '2007-10-29', 'lastUpdatePostDateStruct': {'date': '2007-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life is measured with the FIQ and the EuroQol-5D.', 'timeFrame': '1, 2, 6 and 12 months later'}], 'secondaryOutcomes': [{'measure': 'The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)', 'timeFrame': '1, 2, 6 and 12 months later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Quality of life', 'Primary Care', 'Non-pharmacological treatment', 'Cost / Cost-efficacy'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '23328339', 'type': 'DERIVED', 'citation': 'Luciano JV, Sabes-Figuera R, Cardenosa E, T Penarrubia-Maria M, Fernandez-Vergel R, Garcia-Campayo J, Knapp M, Serrano-Blanco A. Cost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trial. Clin J Pain. 2013 Aug;29(8):702-11. doi: 10.1097/AJP.0b013e318270f99a.'}, {'pmid': '21317775', 'type': 'DERIVED', 'citation': 'Luciano JV, Martinez N, Penarrubia-Maria MT, Fernandez-Vergel R, Garcia-Campayo J, Verduras C, Blanco ME, Jimenez M, Ruiz JM, Lopez del Hoyo Y, Serrano-Blanco A; FibroQoL Study Group. Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial. Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.'}]}, 'descriptionModule': {'briefSummary': 'This research project pretends to demonstrate that a psychoeducative program implemented in the context of PC can produce a significant increase in the quality of life of patients with FM, as well as a decrease in the use of sanitary and social services, compared to usual care.', 'detailedDescription': 'Most fibromyalgic patients are attended at primary care (PC). However, the effectiveness of the treatments prescribed by general practitioners is usually scarce. The main objective of the present research is to assess the efficacy of a structured psychoeducative intervention, combined with relaxation, developed to improve the quality of life of patients suffering fibromyalgia (FM). The second objective is to assess the cost-effectiveness of this multimodal intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)\n\nExclusion Criteria:\n\n* Patients with a diagnosis not based on the ACR criteria\n* Those with cognitive impairment or suffering from physical mental/psychiatric limitations\n* Severe concurrent rheumatologic illness that impede participation in the study evaluations\n* Those who are not expected to live at least 12 months\n* Those without schooling.'}, 'identificationModule': {'nctId': 'NCT00550966', 'acronym': 'FIBRO-Qol', 'briefTitle': 'Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut Catala de Salut'}, 'officialTitle': 'Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]', 'orgStudyIdInfo': {'id': '077/25/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Randomized controlled trial with a 12-month follow-up involving two groups, one of which is the intervention group that includes patients receiving a psychoeducative program and the other is the control group formed by patients treated for FM in the usual way.\n\nSetting. Three urban PC centers in the province of Barcelona (Spain) Sample. The total sample comprises 218 patients (over 18 years of age) suffering FM, selected from a database (Rheumatology service-Viladecans hospital) of patients with this illness. Only those patients introduced in the database between the years 2005 and 2007 are included in the selection. Selected patients are asked for written informed consent to participate in the study.', 'interventionNames': ['Behavioral: Psychoeducative program in fibromyalgic patients']}], 'interventions': [{'name': 'Psychoeducative program in fibromyalgic patients', 'type': 'BEHAVIORAL', 'otherNames': ['Fibromyalgia', 'Psychoeducative program'], 'description': 'Multi-component program including information about the illness, counselling about physical exercise and training in autogenic relaxation. The intervention consists on nine 2 hour sessions delivered during a two month period. The pharmacological treatment prescribed by the physician is maintained in both groups.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08850', 'city': 'Gavà', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'ABS Bartomeu Fabres Anglada. Institut Català de Salut.', 'geoPoint': {'lat': 41.30605, 'lon': 2.00123}}], 'overallOfficials': [{'name': 'Rita Fernández-Vergel, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Català de Salut (ICS)'}, {'name': 'María Teresa Peñarrubia, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Català de Salut (ICS)'}, {'name': 'Elena Blanco, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'ICS'}, {'name': 'Mónica Jiménez, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'ICS'}, {'name': 'Adrián Montesano, psychology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundació Jordi Gol i Gurina. ICS'}, {'name': 'Antonio Serrano, psychiatrist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sant Joan de Déu-Serveis de Salut Mental'}, {'name': 'Juan Vicente Luciano, psychology', 'role': 'STUDY_CHAIR', 'affiliation': 'Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)'}, {'name': 'Mª del Camino Verduras, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'ICS'}, {'name': 'José Miguel Ruíz, Reumatology', 'role': 'STUDY_CHAIR', 'affiliation': 'ICS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Catala de Salut', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': "Agència d'Avaluació de Tecnologia i Recerca Mèdiques", 'class': 'OTHER'}, {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}]}}}