DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms
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|ClinicalTrials.gov Identifier: NCT00130988|
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : July 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Somatoform Disorders||Behavioral: DEPENAS cognitive and behavioural techniques||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Biopsychosocial Treatment for Somatizing Patients Carried Out by the General Practitioner|
|Study Start Date :||January 2001|
|Primary Completion Date :||February 2002|
|Study Completion Date :||March 2003|
- Health related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130988
|Principal Investigator:||Jose M Aiarzaguena, Dr.||Basque Health Service|