A Phase 3 interventional study of DEPENAS cognitive and behavioural techniques in Somatoform Disorders, sponsored by Basque Health Service. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-07-15.
Sponsored by Basque Health Service · Phase 3, Interventional, and Treatment
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.
Patients with unexplained medical symptoms are frequently referred to multiple specialists, including psychiatrists, which often prove ineffective. General practitioners play a key role in the management of these patients and techniques of re-attribution of symptoms have been proposed for general practice, but they have only shown partial results in patients with somatised mental disorders who do not believe that their symptoms have a completely physical cause.
Based on the analysis of psychosocial interventions carried out in general practice over the last 10 years by the principal investigator (JMA), the investigators have empirically structured a new sort of intervention, called DEPENAS. This new intervention integrates different psychotherapeutic models. It starts with the attribution of symptoms to a hormonal imbalance (biological aspect) providing a tangible and exculpatory explanation of the patients' symptoms and follows with normalization/justification of any thought/behavior as a logical consequence derived from the personal and family cycle (systemic model). It ends with a proposal for change: to adapt these thoughts, many of them infantile, to objectives of adulthood (transactional model) using cognitive and behavioral techniques in patients ready for change, or paradoxical techniques for non-prepared subjects.
The OBJECTIVE of this randomized clinical trial was to assess the efficacy of this new intervention carried out by family physicians on patients' self-perceived health related quality of life (SF-36). Each doctor randomly allocated to the new intervention group performed six 30-min programmed and standardized sessions with four patients who presented multiple chronic physical symptoms that remained medically unexplained. Health related quality of life was measured at baseline (1 month before starting therapy), after 3 months of the first appointment (once both study groups had completed five sessions), after 8 months (once the intervention was finished) and at 12 months after enrollment.
They will be COMPARED to patients of family doctors randomly assigned to the control group. These doctors also performed six 30-min programmed and standardized sessions, using in this case "re-attribution techniques": reception and explicit acceptance of the patient's symptoms, examination of emotional and psychosocial problems and establishment of a link of the symptoms with identified emotional problems. Patients' outcomes observed in both groups will be compared on an intention to treat basis, and random-effects longitudinal models will be used to estimate the effect of the intervention on quality of life evolution.
405 studies on the registry are indexed under Somatoform Disorders; 79 are open to participants now.
This study's enrollment of 156 is above the median of 59 across 318 interventional studies indexed under Somatoform Disorders.
Browse Somatoform Disorders studies →Basque Health Service is the lead sponsor of 57 studies on the registry; 1 is open to participants now.
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Health related quality of life
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This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Basque Health Service