Status:

COMPLETED

Treatment of Patients With Longstanding Unexplained Health Complaints

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

Aarhus County, Denmark

Aarhus University Hospital

Conditions:

Somatization Disorder

Eligibility:

All Genders

20-45 years

Phase:

PHASE2

PHASE3

Brief 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 t...

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 o...

Eligibility Criteria

Inclusion

  • Multiple somatic symptoms from several organ systems, without adequate medical explanation.
  • Moderate to severe influence on daily life.
  • The disorder's functional component can easily be separated from a possible well-defined chronic somatic illness.
  • No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (International Classification of Diseases \[ICD-10\]: F20-29, F30-31, F32.3, F33.3)
  • The condition must have been present for at least 2 years.
  • Patients of Scandinavian origin who understand, read, write and speak Danish.

Exclusion

  • No informed consent.
  • An acute psychiatric disorder that demands other treatment, or if the patient is suicidal.
  • Abuse of narcotics or alcohol and (non-prescribed) medicine.
  • Pregnancy.
  • Current industrial injury case or other action for damages.

Key Trial Info

Start Date :

April 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2008

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00132197

Start Date

April 1 2005

End Date

September 1 2008

Last Update

November 16 2011

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Aarhus C, Denmark, 8000