Contact information
Type
Scientific
Primary contact
Dr Javier Garcia Campayo
ORCID ID
Contact details
Hospital Miguel Servet
Avda Isabel la Catolica 1-3
Zaragoza
50.009
Spain
+34 976 253621; +34 686 673302
jgarcamp@arrakis.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/1993
Study information
Scientific title
Acronym
CBTASD
Study hypothesis
Patients randomized to cognitive behavioural therapy significantly improve in measures related to quality of life, somatic symptoms, psychopathology and health services use.
Ethics approval
Aragon Ethics Review Board, approved in June 2005 (ref: 05/24)
Study design
Multi-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Abridged somatization disorder
Intervention
The participants will be randomely allocated to the intervention and control groups in equal numbers.
Intervention group: A manualised intervention program of cognitive behaviour therapy (10 sessions) for somatoform disorders according to Escobar (Arch Intern Med 2006; 166: 1512-18; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16864762)
Control group: Usual care plus "Smith's norms." The general practitioners receive a short letter on recommendations (widely accepted and obtained from evidence-based medicine) to manage patients with somatoform disorders.
Duration of interventions: 3 months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Severity of Clinical Global Impression scale at baseline, 3 and 6 months and 1-year follow-up
Secondary outcome measures
The following will be assessed at baseline, 3 and 6 months and 1-year follow-up:
1. Quality of life: 36-item Short Form health survey (SF-36)
2. Hamilton Depression Scale
3. Hamilton Anxiety Scale
4. Screening for Somatoform Symptoms [SOMS]
Overall trial start date
15/01/2008
Overall trial end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-65 years
2. Fluent in Spanish language
3. Diagnosis of Abridged Somatization Disorder (SSI 4,6) according to Escobar's criteria
4. Stable pharmacological treatment during last month and the expectation to maintain it during the next three months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140 patients
Participant exclusion criteria
1. Primary diagnosis of a psychiatric disorder different from somatization disorder
2. Severe personality disorder that interferes with adequate completion of
the intervention program
3. Impossible to attend the intervention therapy
4. Refusal to participate
Recruitment start date
15/01/2008
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Miguel Servet
Zaragoza
50.009
Spain
Sponsor information
Organisation
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Sponsor details
Ctra. Majadahonda - Pozuelo
Km 2 28220 - Majadahonda
Madrid
28220
Spain
+34 91 5097900
director.cnsa@isciii.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Carlos III Institute of Health (Madrid), Funding for Health Research for Social Security (Instituto de Salud Carlos III, Fondo de Investigaciones Sanitarias de la Seguridad Social) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23788694
Publication citations
-
Results
Moreno S, Gili M, Magallón R, Bauzá N, Roca M, Del Hoyo YL, Garcia-Campayo J, Effectiveness of group versus individual cognitive-behavioral therapy in patients with abridged somatization disorder: a randomized controlled trial., Psychosom Med, 75, 6, 600-608, doi: 10.1097/PSY.0b013e31829a8904.