Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130988
Status:
COMPLETED
Last Update Posted:
2008-07-15
First Post:
2005-08-16
Brief Title:
DEPENAS A Psychosocial Intervention for Patients With Medically Unexplained Symptoms
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
Efficacy of a Biopsychosocial Treatment for Somatizing Patients Carried Out by the General Practitioner
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 normalizationjustification of any thoughtbehavior 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 patients 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
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 normalizationjustification of any thoughtbehavior 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None