CompletedPhase 2/3

Treatment of Patients With Longstanding Unexplained Health Complaints

Denmark120 participantsStarted 2005-04

Plain-language 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.

Who can participate

Age range20 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality)

Timeframe: Measured at baseline and months 4 (end of treatment), 10 and 16

Trial details

NCT IDNCT00132197

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-09