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

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Behavioral: Psychoeducative program in fibromyalgic patients

• Registration Number: NCT00550966
• Lead Sponsor: Institut Catala de Salut

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2007-09
• Study Start: 2007-09
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Last Update Submitted: 2007-10-29
• Study First Posted: 2007-10-30
• Last Update Posted: 2007-10-30
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Psychoeducative program in fibromyalgic patients	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.

Primary Outcome Measures

Name	Time	Method
Quality of life is measured with the FIQ and the EuroQol-5D.	1, 2, 6 and 12 months later

Secondary Outcome Measures

Name	Time	Method
The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)	1, 2, 6 and 12 months later

Trial Locations

Locations (1)

ABS Bartomeu Fabres Anglada. Institut Català de Salut.; 🇪🇸 Gava, Barcelona, Spain