FibromyalgiaFIBRO-QolNCT00550966
Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
A study testing Psychoeducative program in fibromyalgic patients in people with Fibromyalgia, run by Institut Catala de Salut at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Psychoeducative program in fibromyalgic patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
ABS Bartomeu Fabres Anglada. Institut Català de Salut.
Gavà, Barcelona, 08850
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Psychoeducative program in fibromyalgic patients
- Keywords
- Fibromyalgia, Quality of life, Primary Care, Non-pharmacological treatment, Cost / Cost-efficacy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducative program in fibromyalgic patientsBehavioural
Also called Fibromyalgia, Psychoeducative program
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Behavioral: Psychoeducative program in fibromyalgic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life is measured with the FIQ and the EuroQol-5D.
Measured: 1, 2, 6 and 12 months later
Secondary outcomes (1)
The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)
Measured: 1, 2, 6 and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startSep 2007
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Catala de Salut
- Sponsor type
- Other government
- Collaborators
- Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Rita Fernández-Vergel, Doctor, Principal investigator, Institut Català de Salut (ICS)María Teresa Peñarrubia, Doctor, Study director, Institut Català de Salut (ICS)Elena Blanco, Doctor, Study chair, ICSMónica Jiménez, Doctor, Study chair, ICSAdrián Montesano, psychology, Study director, Fundació Jordi Gol i Gurina. ICSAntonio Serrano, psychiatrist, Study director, Sant Joan de Déu-Serveis de Salut MentalJuan Vicente Luciano, psychology, Study chair, Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)Mª del Camino Verduras, Doctor, Study chair, ICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550966
- Sponsor's protocol ID
- 077/25/2006
- Acronym
- FIBRO-Qol
- Status last verified
- Sep 2007
- First submitted
- 29 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23328339Luciano 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.
PubMed 21317775
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]
- ClinicalTrials.gov ID
- NCT00550966
- Acronym / sponsor ID
- FIBRO-Qol / 077/25/2006
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Quality of life, Primary Care, Non-pharmacological treatment, Cost / Cost-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Institut Catala de SalutOther government
- Collaborators
- Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Study start
- Sep 2007
- Study completion
- Feb 2010 (estimated)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Psychoeducative program in fibromyalgic patientsRandomized 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducative program in fibromyalgic patientsAlso: Fibromyalgia, Psychoeducative programMulti-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. | Behavioural | 1 |
Primary outcome
Quality of life is measured with the FIQ and the EuroQol-5D.
Time frame: 1, 2, 6 and 12 months later
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
- Derived from this study: PubMed 23328339Luciano 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.
- Derived from this study: PubMed 21317775Luciano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Fernández-Vergel, Doctor principal investigator
Institut Català de Salut (ICS)
María Teresa Peñarrubia, Doctor study director
Institut Català de Salut (ICS)
Elena Blanco, Doctor study chair
ICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducative program in fibromyalgic patients in people with Fibromyalgia, run by Institut Catala de Salut at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life is measured with the FIQ and the EuroQol-5D. (time frame: 1, 2, 6 and 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00550966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2007.