Treatment of Patients With Longstanding Unexplained Health Complaints

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00132197

Collaborator

Aarhus County, Denmark (Other), Aarhus University Hospital (Other)

120

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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 the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.

Condition or Disease	Intervention/Treatment	Phase
Somatization Disorder	Behavioral: Cognitive Behavioral Therapy Procedure: Recommendation of care (letter to general practitioner [GP])	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

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) [Measured at baseline and months 4 (end of treatment), 10 and 16]

Secondary Outcome Measures

Psychosocial effect measures: Social level of functioning, emotional disorders, coping strategies measured with relevant sub-scales from the SF-36, WHO-DAS II, CSQ, Symptom Checklist SCL, Whiteley-7 [Measured at baseline and months 4 (end of treatment), 10 and 16]
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 [Measured for a period of one year prior to referral (baseline) and a period of one year after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.