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.

Condition	Intervention	Phase
Somatization Disorder	Behavior: Cognitive Behavioral Therapy  Behavior: Social counselling  Procedure: Recommendation of care (letter to GP)	Phase II Phase III

Further Study Details: 

Primary Outcomes: Physical Health measured with MOS-SF-36 Physical Component Summary
Secondary Outcomes: 1)Psychosocial effect measures: Social level of functioning, emotional disorders, coping strategies measured with relevant sub-scales from SF-36, WHO-DAS II, CSQ, SCL, Whiteley-7.; 2) Use of health care measured by information from the National Patient Register, the Psychiatric Central Register, the National Health Service Register and The Danish Medicines Agency.
Expected Total Enrollment:  120

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.

Ages Eligible for Study:  20 Years   -   45 Years,  Genders Eligible for Study:  Both

Criteria

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 (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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00132197

Per Fink, Dr.Med.Sc.      0045 8949 4310    pfink@as.aaa.dk
Andreas Schröder, MD      0045 8949 4338    ansch@as.aaa.dk

Denmark
      Per Fink, Aarhus C,  8000,  Denmark; Recruiting

Study chairs or principal investigators

Per Fink, Dr.Med.Sc.,  Study Director,  The Research Clinic for Functional Disorders, Aarhus University Hospital   

Study ID Numbers:  20052
Last Updated:  August 18, 2005
Record first received:  July 19, 2005
ClinicalTrials.gov Identifier:  NCT00132197
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-08-23