Effectiveness of the psychological and pharmacological treatment of catastrophisation in patients with fibromyalgia: a controlled randomised trial
| ISRCTN | ISRCTN10804772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10804772 |
| Secondary identifying numbers | ETES nº PI07/90959 |
- Submission date
- 11/06/2008
- Registration date
- 29/09/2008
- Last edited
- 02/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Javier Garcia-Campayo
Scientific
Scientific
Servicio de Psiquiatría
Hospital Universitario Miguel Servet
Avda Isabel La Católica 1
Zaragoza
50009
Spain
| Phone | +34 (0)976 25 36 21 |
|---|---|
| jgarcamp@arrakis.es |
Study information
| Study design | Multicentre three-arm random allocation controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Pharmacological and psychological treatments are more effective for the treatment of pain catastrophising in patients with fibromyalgia than usual treatment at primary care level. |
| Ethics approval(s) | Ethical Review Board of the Regional Health Authority, February 2007, ref: ETES nº PI07/90959 |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Pregabalin, duloxetine |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/09/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 patients (60 in each of the three groups) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Servicio de Psiquiatría
Zaragoza
50009
Spain
50009
Spain
Sponsor information
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Research organisation
Research organisation
C/ Sinesio Delgado 6
Madrid
28029
Spain
| Phone | +34 (0)91 82 22 131 |
|---|---|
| oficina.informacion@isciii.es | |
| Website | http://www.isciii.es |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Research organisation
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: ETES nº PI07/90959)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/04/2009 | Yes | No | |
| Results article | results | 01/10/2014 | Yes | No |
