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Cognitive Behaviour Therapy for Abridged Somatization Disorder (Somatic Symptom Index [SSI] 4,6) patients in primary care
DOI 10.1186/ISRCTN69944771
ClinicalTrials.gov identifier
EudraCT number
Public title Cognitive Behaviour Therapy for Abridged Somatization Disorder (Somatic Symptom Index [SSI] 4,6) patients in primary care
Scientific title
Acronym CBTASD
Serial number at source 04/1993
Study hypothesis Patients randomized to cognitive behavioural therapy significantly improve in measures related to quality of life, somatic symptoms, psychopathology and health services use.
Lay summary Not provided at time of registration
Ethics approval Aragon Ethics Review Board, approved in June 2005 (ref: 05/24)
Study design Multi-centre randomized controlled trial
Countries of recruitment Spain
Disease/condition/study domain Abridged somatization disorder
Participants - 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
Participants - 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
Anticipated start date 15/01/2008
Anticipated end date 01/07/2009
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 140 patients
Interventions 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
Primary outcome measure(s) Severity of Clinical Global Impression scale at baseline, 3 and 6 months and 1-year follow-up
Secondary outcome measure(s) 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]
Sources of funding 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)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23788694
Contact name Dr  Javier  Garcia Campayo
  Address Hospital Miguel Servet
Avda Isabel la Catolica 1-3
  City/town Zaragoza
  Zip/Postcode 50.009
  Country Spain
  Tel +34 976 253621; +34 686 673302
  Fax +34 976 254006
  Email jgarcamp@arrakis.es
Sponsor Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
  Address Ctra. Majadahonda - Pozuelo
Km 2 28220 - Majadahonda
  City/town Madrid
  Zip/Postcode 28220
  Country Spain
  Tel +34 91 5097900
  Fax +34 91 5097991
  Email director.cnsa@isciii.es
  Sponsor website: http://www.isciii.es
Date applied 23/12/2007
Last edited 17/03/2014
Date ISRCTN assigned 14/02/2008
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