- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00130988
DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms
Efficacy of a Biopsychosocial Treatment for Somatizing Patients Carried Out by the General Practitioner
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription
Phase
- Phase 3
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Qualité de vie liée à la santé
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jose M Aiarzaguena, Dr., Basque Health Service
Publications et liens utiles
Publications générales
- Barsky AJ, Borus JF. Somatization and medicalization in the era of managed care. JAMA. 1995 Dec 27;274(24):1931-4.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 00/00854
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Essais cliniques sur DEPENAS cognitive and behavioural techniques
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Afyonkarahisar Health Sciences UniversityRecrutementAccident vasculaire cérébralTurquie
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Kaohsiung Medical University Chung-Ho Memorial...Kaohsiung Medical University; Ministry of Science and Technology, TaiwanRecrutementLa schizophrénie | Maladie mentale | Trouble psychiatrique | Cognition | Solde | Double tâche | Prévention des chutesTaïwan