|
ISRCTN
|
ISRCTN10804772
|
|
DOI
|
10.1186/ISRCTN10804772
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Effectiveness of the psychological and pharmacological treatment of catastrophisation in patients with fibromyalgia: a controlled randomised trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
ETES nº PI07/90959
|
|
Study hypothesis
|
Pharmacological and psychological treatments are more effective for the treatment of pain catastrophising in patients with fibromyalgia than usual treatment at primary care level.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics approval received from the Ethical Review Board of the Regional Health Authority in February 2007 (ref: ETES nº PI07/90959).
|
|
Study design
|
Multicentre three-arm random allocation controlled trial
|
|
Countries of recruitment
|
Spain
|
|
Disease/condition/study domain
|
Fibromyalgia
|
|
Participants - inclusion criteria
|
1. Aged 18 - 65 years, either sex
2. Able to understand and read Spanish
3. Fulfil criteria for primary fibromyalgia according to the American College of Rheumatology
4. No previous psychological treatment
5. No pharmacological treatment or acceptance to discontinue it two weeks before the onset of the study
6. Signed informed consent
|
|
Participants - exclusion criteria
|
1. Severe Axis I psychiatric disorder (dementia, schizophrenia, paranoid disorder, abuse of alcohol and/or drug disorders)
2. Severe Axis II disorder from the clinician viewpoint that prevents the patient from following the treatment protocol
3. Pregnancy or lactation
4. Refusal to participate
|
|
Anticipated start date
|
01/09/2008
|
|
Anticipated end date
|
31/12/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
180 patients (60 in each of the three groups)
|
|
Interventions
|
Psychological intervention:
Manualised protocol developed by Prof. Escobar et al, of the University of New Jersey, for the treatment of somatoform disorders that has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy.
Pharmacological intervention:
In this group of patients, pregabalin (300 - 450 mg/day), recommended for the treatment of fibromyalgia, associated with duloxetine (60 - 120 mg/day) if there is comorbid depression, will be administered.
Treatment as usual at primary care level:
This group will follow the usual treatment given at primary care level.
|
|
Primary outcome measure(s)
|
The major outcome is pain catastrophising in patients with fibromyalgia. This construct will be assessed with the Spanish version of the Pain Catastrophising Scale. Assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention
|
|
Secondary outcome measure(s)
|
1. The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class: administered only at baseline
2. The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview, a psychiatric interview extensively used for the study of somatoform disorders: administered only at baseline
3. Hamilton test for Anxiety (HAM-A) and for Depression (HAM-D); assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention
4. Fibromyalgia Impact Questionnaire (FIQ): the FIQ is a 10-item self-report questionnaire developed to measure the health status of fibromyalgia patients; assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention
|
|
Sources of funding
|
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: ETES nº PI07/90959)
|
|
Trial website
|
|
|
Publications
|
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19389246
|
|
Contact name
|
Dr
Javier
Garcia-Campayo
|
|
Address
|
Servicio de Psiquiatría
Hospital Universitario Miguel Servet
Avda Isabel La Católica 1
|
|
City/town
|
Zaragoza
|
|
Zip/Postcode
|
50009
|
|
Country
|
Spain
|
|
Tel
|
+34 (0)976 25 36 21
|
|
Fax
|
+34 (0)976 25 40 06
|
|
Email
|
jgarcamp@arrakis.es
|
|
Sponsor
|
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
|
|
Address
|
C/ Sinesio Delgado 6
|
|
City/town
|
Madrid
|
|
Zip/Postcode
|
28029
|
|
Country
|
Spain
|
|
Tel
|
+34 (0)91 82 22 131
|
|
Fax
|
+34 (0)91 38 77 789
|
|
Email
|
oficina.informacion@isciii.es
|
|
Sponsor website:
|
http://www.isciii.es
|
|
Date applied
|
11/06/2008
|
|
Last edited
|
20/07/2009
|
|
Date ISRCTN assigned
|
29/09/2008
|
