DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms
Condition: Somatoform Disorders
MeSH terms: Medically Unexplained Symptoms; Somatoform Disorders
Study type: Interventional
Phase: Phase 3

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 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.
    

Intervention name(s): DEPENAS cognitive and behavioural techniques
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Somatoform Disorders; Medically unexplained symptoms; Physician-Patient Relations; Primary Health Care; Family Physician; psychosocial therapy; re-attribution of symptoms; cluster randomised controlled trial