ClinicalTrials.gg
CompletedNCT00130988Updated Jul 15, 2008

DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms

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

Phase
Phase 3
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Somatoform Disorders

Keywords

  • Somatoform Disorders
  • Medically unexplained symptoms
  • Physician-Patient Relations
  • Primary Health Care
  • Family Physician
  • psychosocial therapy
  • re-attribution of symptoms
  • cluster randomised controlled trial
03

In context

Somatoform Disorders

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 →

Lead sponsor

Basque Health Service is the lead sponsor of 57 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Dementia
  • Psychotic disorders
  • Drug dependence
  • Bipolar disorder
  • Eating disorders
  • Malingering patients
  • Patients engaged in psychotherapy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants

Interventions

  • BehavioralDEPENAS cognitive and behavioural techniques
06

What researchers measure

Primary outcomes

  1. Health related quality of life

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Aiarzaguena JM, Grandes G, Alonso-Arbiol I, del Campo Chavala JL, Oleaga Fernandez 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. doi: 10.1016/s0212-6567(02)70637-9. Spanish. PubMed 12061987 ↗
  • Rosendal M, Olesen F, Fink P. Management of medically unexplained symptoms. BMJ. 2005 Jan 1;330(7481):4-5. doi: 10.1136/bmj.330.7481.4. No abstract available. PubMed 15626783 ↗
  • Mayou R, Farmer A. ABC of psychological medicine: Functional somatic symptoms and syndromes. BMJ. 2002 Aug 3;325(7358):265-8. doi: 10.1136/bmj.325.7358.265. No abstract available. PubMed 12153926 ↗
  • 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. doi: 10.1136/bmj.325.7372.1082. PubMed 12424170 ↗
  • 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. doi: 10.1093/fampra/19.2.178. PubMed 11906984 ↗
  • Barsky AJ, Borus JF. Somatization and medicalization in the era of managed care. JAMA. 1995 Dec 27;274(24):1931-4. PubMed 8568987 ↗
  • Aiarzaguena JM, Grandes G, Gaminde I, Salazar A, Sanchez A, Arino 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. doi: 10.1017/S0033291706009536. Epub 2006 Dec 13. PubMed 17164029 ↗
  • Aiarzaguena JM, Gaminde I, Grandes G, Salazar A, Alonso I, Sanchez A. Somatisation in primary care: experiences of primary care physicians involved in a training program and in a randomised controlled trial. BMC Fam Pract. 2009 Nov 25;10:73. doi: 10.1186/1471-2296-10-73. PubMed 19930729 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00130988
Lead sponsor
Basque Health Service
Collaborators
Carlos III Health Institute
First posted
Aug 17, 2005
Start date
Jan 2001
Primary completion
Feb 2002
Completion
Mar 2003
Last update
Jul 15, 2008

Study contacts

Jose M Aiarzaguena, Dr.
principal investigator · Basque Health Service

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion