- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132197
Treatment of Patients With Longstanding Unexplained Health Complaints
Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Aarhus C, Denmark, 8000
- Per Fink
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: Measured at baseline and months 4 (end of treatment), 10 and 16
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Measured at baseline and months 4 (end of treatment), 10 and 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Measured at baseline and months 4 (end of treatment), 10 and 16
|
Measured at baseline and months 4 (end of treatment), 10 and 16
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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
Time Frame: Measured for a period of one year prior to referral (baseline) and a period of one year after treatment
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Measured for a period of one year prior to referral (baseline) and a period of one year after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Per Fink, Dr.Med.Sc., The Research Clinic for Functional Disorders, Aarhus University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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