Treatment of Patients With Longstanding Unexplained Health Complaints
Condition: Somatization Disorder
MeSH terms: Somatoform Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the effect of specialized treatment (including
      cognitive therapy, social counselling and a recommendation letter to the patients' primary
      care physician) on the functional level, emotional problems, and use of health care in
      patients with chronic medically unexplained symptoms.
    

Detailed description: 
      Medically unexplained or functional somatic symptoms are complaints, which are not
      attributable to any verifiable, conventionally defined disease, or which cannot adequately be
      supported by clinical or para-clinical findings.

      Functional somatic symptoms are common in the population and in all clinical settings, both
      in primary and secondary care. The disorders range from mild, transitory cases, which are
      difficult to delimit in relation to normality, to severe chronic cases with multiple symptoms
      from different organ systems.

      Chronic multiple functional somatic symptoms often cause frustration for both GPs and
      patients due to lack of availability of specialized treatment offers. Patients may have a
      high use of health care, and their social and functional level is low. In Denmark, patients
      with chronic multiple functional somatic symptoms account for at least 10% of the early
      retirement pensions each year.

      Diverse interventions have been effective in the management and treatment of patients with
      functional disorders. Care recommendation letters for the GPs have both helped reduce the
      patients' use of health care and improved their level of physical functioning. Randomized
      controlled trials (RCT) have shown that cognitive behavioral treatment (CBT) has effect on
      specific patient groups with functional disorders. Through a combination of cognitive
      behavioral therapy, social counselling and recommendation letters, it is possible to offer
      patients with chronic functional somatic symptoms a presumably effective and cost-effective
      treatment.
    

Intervention name(s): Cognitive Behavioral Therapy; Recommendation of care (letter to general practitioner [GP])
Intervention type(s): Behavioral; Procedure
Intervention description(s): 1. Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist.; After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional somatic symptoms; Cognitive behavioral therapy; somatization disorder; SF-36; cost-effectiveness; Medically unexplained symptoms