DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms

This study has been completed.
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT00130988
First received: August 16, 2005
Last updated: July 11, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Somatoform Disorders
Behavioral: DEPENAS cognitive and behavioural techniques
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of a Biopsychosocial Treatment for Somatizing Patients Carried Out by the General Practitioner

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Health related quality of life

Estimated Enrollment: 156
Study Start Date: January 2001
Study Completion Date: March 2003
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130988

Sponsors and Collaborators
Basque Health Service
Carlos III Health Institute
Investigators
Principal Investigator: Jose M Aiarzaguena, Dr. Basque Health Service
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose María Aiarzaguena, Basque Health Service
ClinicalTrials.gov Identifier: NCT00130988     History of Changes
Other Study ID Numbers: 00/00854
Study First Received: August 16, 2005
Last Updated: July 11, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by Basque Health Service:
Somatoform Disorders
Medically unexplained symptoms
Physician-Patient Relations
Primary Health Care
Family Physician
psychosocial therapy
re-attribution of symptoms
cluster randomised controlled trial

Additional relevant MeSH terms:
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014