TY - JOUR
KW - Adolescent
KW - Adult
KW - Aged
KW - Anxiety Disorders/diagnosis/psychology/therapy
KW - Cognitive Therapy/methods
KW - Depression/diagnosis/psychology/therapy
KW - Diagnosis, Differential
KW - Drug Therapy/methods
KW - Female
KW - Humans
KW - Interview, Psychological
KW - Male
KW - Middle Aged
KW - Primary Health Care
KW - Questionnaires
KW - Severity of Illness Index
KW - Somatoform Disorders/diagnosis/drug therapy/therapy
AU - R. Magallon
AU - M. Gili
AU - S. Moreno
AU - N. Bauza
AU - J. Garcia-Campayo
AU - M. Roca
AU - Y. Ruiz
AU - E. Andres
A1 - 
AB - 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.
BT - BMC psychiatry
C5 - Medically Unexplained Symptoms
CY - England
DO - 10.1186/1471-244X-8-47
JF - BMC psychiatry
N2 - 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.
PP - England
PY - 2008
SN - 1471-244X; 1471-244X
SP - 47
T1 - Cognitive-behaviour therapy for patients with Abridged Somatization Disorder (SSI 4,6) in primary care: a randomized, controlled study
T2 - BMC psychiatry
TI - Cognitive-behaviour therapy for patients with Abridged Somatization Disorder (SSI 4,6) in primary care: a randomized, controlled study
U1 - Medically Unexplained Symptoms
U2 - 18570681
U3 - 10.1186/1471-244X-8-47
VL - 8
VO - 1471-244X; 1471-244X
Y1 - 2008
ER -