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
Protocol serial number	ETES nº PI07/90959
Sponsor	The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Funder	The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: 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

Servicio de Psiquiatría
Hospital Universitario Miguel Servet
Avda Isabel La Católica 1
Zaragoza
50009
Spain

Phone	+34 (0)976 25 36 21
Email	jgarcamp@arrakis.es

Study information

Primary study design	Interventional
Study design	Multicentre three-arm random allocation controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Pregabalin, duloxetine
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
Key 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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	180
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2014		Yes	No
Protocol article	protocol	23/04/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes