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

October 29, 2007 updated by: Institut Catala de Salut
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • Fibromyalgia
  • Psychoeducative program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1, 2, 6 and 12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Catala de Salut

Collaborators

Agència d'Avaluació de Tecnologia i Recerca Mèdiques
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (Estimate)

October 30, 2007

Study Record Updates

Last Update Posted (Estimate)

October 30, 2007

Last Update Submitted That Met QC Criteria

October 29, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 077/25/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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