Treatment of Patients With Longstanding Unexplained Health Complaints

University of Aarhus

Status and phase

Completed

Phase 3

Phase 2

Conditions

Somatization Disorder

Treatments

Behavioral: Cognitive Behavioral Therapy

Procedure: Recommendation of care (letter to general practitioner [GP])

Study type

Interventional

Funder types

Other

Identifiers

NCT00132197

20052

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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.