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Open Access Study protocol

Cognitive-behaviour therapy for patients with Abridged Somatization Disorder (SSI 4,6) in primary care: a randomized, controlled study

Rosa Magallón1, Margalida Gili2, Sergio Moreno3, Natalia Bauzá2, Javier García-Campayo3*, Miquel Roca4, Yolanda Ruiz1 and Eva Andrés1

Author Affiliations

1 Department of Family Medicine, Arrabal Health Centre and University of Zaragoza, Spain; Grupo Aragonés de Investigación en Atención Primaria, Red de Actividades Preventivas y de Promoción de la Salud (REDIAPP) (G06/018), Instituto Aragonés de Ciencias de la Salud (IACS), Spain

2 Departament of Psychology. Illes Balears University, Palma de Mallorca, Spain

3 Department of Psychiatry, Miguel Servet Hospital and University of Zaragoza, Spain

4 Unit of Psychiatry and Clinic Psychology, Juan March Hospital, Illes Balears University, Palma de Mallorca, Spain

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BMC Psychiatry 2008, 8:47  doi:10.1186/1471-244X-8-47

Published: 22 June 2008

Abstract

Background

Somatoform disorders are characterized by the presence of multiple somatic symptoms without an organic cause that completely explains their symptoms.

These patients generate a high cost in health services. We aim to evaluate the effectiveness and feasibility of a cognitive-behaviour therapy (CBT) programme, administered in group and individual formats in primary care for patients who are diagnosed with abridged somatization disorder.

Method/design

Design: Multicentre, randomized, controlled trial involving 3 groups, one of which is the control group consisting of standardized recommended treatment for somatization disorder in primary care (Smith's norms) and the 2 others, the intervention groups, consisting of cognitive-behavioural therapy (10 sessions) administered in individual format (intervention group 1) or in group format (intervention group 2).

Setting: 29 primary care health centres in the province of Zaragoza and 3 primary care health centres in the province of Mallorca, Spain.

Sample: N = 204 patients, (68 in each of the three groups), aged 18–65 years, able to understand and read Spanish, who fulfil Escobar's criteria of Abridgged Somatization Disorder (SSI 4,6), stable with pharmacotherapy over the previous month, and who will remain stable for the next 3 months in the doctor's opinion, having signed informed consent.

Intervention: Control group: Standardized recommended treatment for somatization disorder in primary care (Smith's norms). Intervention group: 10 weekly sessions of CBT, following a protocol designed by Prof. Escobar's group at UMDNJ, USA. There are 2 different treatment conditions: individual and group format.

Measurements: Survey on the use of health services, number and severity of somatic symptoms, anxiety, depression, quality of life and clinical global impression. The interviewers will not know which group the patient belongs to (blind). The assessments will be carried out at baseline, post-treatment, 6 months and 12 post-treatment.

Main variables: Utilization of health services, number and severity of somatic symptoms.

Analysis: The analysis will be per intent to treat. We will use the general linear models of the SPSS v.15 statistical package, to analyse the effect of treatment on the result variable (utilization of health services, number and severity of somatic symptoms).

Discussion

It is necessary to develop more effective psychological treatments for somatoform disorders. This randomised clinical trial will determine whether cognitive behaviour therapy, both in group or in individual format, is effective for the treatment of these patients.

Trial registration

Current controlled trials ISRCTN69944771