Somatoform Disorders Clinical Trial
Official title:
Efficacy of a Biopsychosocial Treatment for Somatizing Patients Carried Out by the General Practitioner
Verified date | July 2008 |
Source | Basque Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
General practitioners play a key role in the management of one of the most complex problems facing the health care system: the large group of patients with unexplained medical symptoms, but effective treatment strategies are lacking in primary care. The purpose of this study is to compare a new intervention delivered by the general practitioner versus re-attribution of symptoms, which is the currently recommended best treatment for patients with high levels of medically unexplained physical symptoms.
Status | Completed |
Enrollment | 156 |
Est. completion date | March 2003 |
Est. primary completion date | February 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients between 18 and 65 years of age, who had presented (over the course of their lives) six or more medically unexplained somatic symptoms for female subjects and four or more for male subjects - At least one of the symptoms would have continued to be present during the last year Exclusion Criteria: - Dementia - Psychotic disorders - Drug dependence - Bipolar disorder - Eating disorders - Malingering patients - Patients engaged in psychotherapy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service | Carlos III Health Institute |
Aiarzaguena JM, Grandes G, Alonso-Arbiol I, del Campo Chavala JL, Oleaga Fernández MB, Marco De Juana J. [Bio-psychosocial treatment approach to somatizing patients in primary care: a pilot study]. Aten Primaria. 2002 May 31;29(9):558-61. Spanish. — View Citation
Aiarzaguena JM, Grandes G, Gaminde I, Salazar A, Sánchez A, Ariño J. A randomized controlled clinical trial of a psychosocial and communication intervention carried out by GPs for patients with medically unexplained symptoms. Psychol Med. 2007 Feb;37(2):283-94. Epub 2006 Dec 13. — View Citation
Barsky AJ, Borus JF. Somatization and medicalization in the era of managed care. JAMA. 1995 Dec 27;274(24):1931-4. — View Citation
Mayou R, Farmer A. ABC of psychological medicine: Functional somatic symptoms and syndromes. BMJ. 2002 Aug 3;325(7358):265-8. — View Citation
Raine R, Haines A, Sensky T, Hutchings A, Larkin K, Black N. Systematic review of mental health interventions for patients with common somatic symptoms: can research evidence from secondary care be extrapolated to primary care? BMJ. 2002 Nov 9;325(7372):1082. Review. — View Citation
Rosendal M, Olesen F, Fink P. Management of medically unexplained symptoms. BMJ. 2005 Jan 1;330(7481):4-5. — View Citation
Wileman L, May C, Chew-Graham CA. Medically unexplained symptoms and the problem of power in the primary care consultation: a qualitative study. Fam Pract. 2002 Apr;19(2):178-82. — View Citation
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