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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00550966
Acronym
FIBRO-Qol
Enrollment
109
Registered
2007-10-30
Start date
2007-09-30
Completion date
2010-02-28
Last updated
2007-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

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

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.

Interventions

BEHAVIORALPsychoeducative 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.

Sponsors

Agència d'Avaluació de Tecnologia i Recerca Mèdiques
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
CollaboratorOTHER
Institut Catala de Salut
Lead SponsorOTHER_GOV

Study design

Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026