Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] (FIBRO-Qol)

Institut Catala de Salut

Status: Unknown

Conditions: Fibromyalgia

Treatments: Behavioral: Psychoeducative program in fibromyalgic patients

Study type: Interventional

Funder types: Other

Identifiers

NCT00550966

077/25/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

109 participants in 1 patient group

1

Active Comparator group

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. 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.

Treatment:

Behavioral: Psychoeducative program in fibromyalgic patients