Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] (FIBRO-Qol)
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|ClinicalTrials.gov Identifier: NCT00550966|
Recruitment Status : Unknown
Verified September 2007 by Institut Catala de Salut.
Recruitment status was: Enrolling by invitation
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
|Condition or disease||Intervention/treatment|
|Fibromyalgia||Behavioral: Psychoeducative program in fibromyalgic patients|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]|
|Study Start Date :||September 2007|
|Estimated Study Completion Date :||February 2010|
Active Comparator: 1
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.
Setting. 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.
Behavioral: Psychoeducative program in fibromyalgic patients
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.
- Quality of life is measured with the FIQ and the EuroQol-5D. [ Time Frame: 1, 2, 6 and 12 months later ]
- The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI) [ Time Frame: 1, 2, 6 and 12 months later ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550966
|ABS Bartomeu Fabres Anglada. Institut Català de Salut.|
|Gava, Barcelona, Spain, 08850|
|Principal Investigator:||Rita Fernández-Vergel, Doctor||Institut Català de Salut (ICS)|
|Study Director:||María Teresa Peñarrubia, Doctor||Institut Català de Salut (ICS)|
|Study Chair:||Elena Blanco, Doctor||ICS|
|Study Chair:||Mónica Jiménez, Doctor||ICS|
|Study Director:||Adrián Montesano, psychology||Fundació Jordi Gol i Gurina. ICS|
|Study Director:||Antonio Serrano, psychiatrist||Sant Joan de Déu-Serveis de Salut Mental|
|Study Chair:||Juan Vicente Luciano, psychology||Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)|
|Study Chair:||Mª del Camino Verduras, Doctor||ICS|
|Study Chair:||José Miguel Ruíz, Reumatology||ICS|