Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] - Full Text View

Sponsors and Collaborators:	Institut Catala de Salut Agencia d'Avaluació, Tecnologia i recerca mèdica (AATRM) Jordi Gol i Gurina Foundation
Information provided by:	Institut Catala de Salut
ClinicalTrials.gov Identifier:	NCT00550966

Purpose

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.

Condition	Intervention
Fibromyalgia	Behavioral: Psychoeducative program in fibromyalgic patients

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]

Further study details as provided by Institut Catala de Salut:

Primary Outcome Measures:

Quality of life is measured with the FIQ and the EuroQol-5D. [ Time Frame: 1, 2, 6 and 12 months later ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	109
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Active Comparator 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.

Arms

Assigned Interventions

1: Active Comparator

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)

Exclusion Criteria:

Patients with a diagnosis not based on the ACR criteria
Those with cognitive impairment or suffering from physical mental/psychiatric limitations
Severe concurrent rheumatologic illness that impede participation in the study evaluations
Those who are not expected to live at least 12 months
Those without schooling.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550966

Locations

Spain, Barcelona
ABS Bartomeu Fabres Anglada. Institut Català de Salut.
Gava, Barcelona, Spain, 08850

Sponsors and Collaborators

Institut Catala de Salut

Agencia d'Avaluació, Tecnologia i recerca mèdica (AATRM)

Jordi Gol i Gurina Foundation

Investigators

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

More Information

Study ID Numbers:	077/25/2006
Study First Received:	October 29, 2007
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00550966
Health Authority:	Spain: Ethics Committee

Keywords provided by Institut Catala de Salut:

Fibromyalgia
Quality of life
Primary Care
Non-pharmacological treatment
Cost / Cost-efficacy

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Quality of Life
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009