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Effectiveness of the psychological and pharmacological treatment of catastrophisation in patients with fibromyalgia: a controlled randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10804772
Enrollment
180
Registered
2008-09-29
Start date
2008-09-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Fibromyalgia Musculoskeletal Diseases Other soft tissue disorders, not elsewhere classified

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

Sponsors

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026