MedDataX Logo

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

NCT ID: NCT00550966

Last Updated: 2007-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Psychoeducative program in fibromyalgic patients

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fibromyalgia Psychoeducative program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agència d'Avaluació de Tecnologia i Recerca Mèdiques

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role collaborator

Institut Catala de Salut

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rita Fernández-Vergel, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institut Català de Salut (ICS)

María Teresa Peñarrubia, Doctor

Role: STUDY_DIRECTOR

Institut Català de Salut (ICS)

Elena Blanco, Doctor

Role: STUDY_CHAIR

ICS

Mónica Jiménez, Doctor

Role: STUDY_CHAIR

ICS

Adrián Montesano, psychology

Role: STUDY_DIRECTOR

Fundació Jordi Gol i Gurina. ICS

Antonio Serrano, psychiatrist

Role: STUDY_DIRECTOR

Sant Joan de Déu-Serveis de Salut Mental

Juan Vicente Luciano, psychology

Role: STUDY_CHAIR

Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)

Mª del Camino Verduras, Doctor

Role: STUDY_CHAIR

ICS

José Miguel Ruíz, Reumatology

Role: STUDY_CHAIR

ICS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ABS Bartomeu Fabres Anglada. Institut Català de Salut.

Gavà, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Luciano JV, Sabes-Figuera R, Cardenosa E, T Penarrubia-Maria M, Fernandez-Vergel R, Garcia-Campayo J, Knapp M, Serrano-Blanco A. Cost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trial. Clin J Pain. 2013 Aug;29(8):702-11. doi: 10.1097/AJP.0b013e318270f99a.

Reference Type DERIVED
PMID: 23328339 (View on PubMed)

Luciano JV, Martinez N, Penarrubia-Maria MT, Fernandez-Vergel R, Garcia-Campayo J, Verduras C, Blanco ME, Jimenez M, Ruiz JM, Lopez del Hoyo Y, Serrano-Blanco A; FibroQoL Study Group. Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial. Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.

Reference Type DERIVED
PMID: 21317775 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

077/25/2006

Identifier Type: -

Identifier Source: org_study_id