Treatment of Patients With Longstanding Unexplained Health Complaints

Somatization Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132197
• Other study ID #: 20052
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 19, 2005
• Last updated: November 11, 2011
• Start date: April 2005
• Est. completion date: September 2008

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Somatization Disorder
• Somatoform Disorders

Intervention

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.

Locations

Country	Name	City	State
Denmark	Per Fink	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus County, Denmark, Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

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