Treatment of Patients With Longstanding Unexplained Health Complaints
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|ClinicalTrials.gov Identifier: NCT00132197|
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : November 16, 2011
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- Behavioral: Cognitive Behavioral Therapy
1. Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist.
- Procedure: Recommendation of care (letter to general practitioner [GP])
After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities.
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132197
|Aarhus C, Denmark, 8000|
|Study Director:||Per Fink, Dr.Med.Sc.||The Research Clinic for Functional Disorders, Aarhus University Hospital|