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Treatment of Patients With Longstanding Unexplained Health Complaints
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Aarhus University Hospital
County of Aarhus
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00132197
  Purpose

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 Intervention Phase
Somatization Disorder
Behavioral: Cognitive Behavioral Therapy
Procedure: Recommendation of care (letter to general practitioner [GP])
Phase II
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Physical Health measured with Medical Outcomes Study 36-Item Short Form (MOS-SF-36) Physical Component Summary [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

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 [ Time Frame: September 2009 ] [ Designated as safety issue: No ]
  • 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: September 2009 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: April 2005
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132197

Locations
Denmark
Per Fink
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
County of Aarhus
Investigators
Study Director: Per Fink, Dr.Med.Sc. The Research Clinic for Functional Disorders, Aarhus University Hospital
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Aarhus University Hospital ( Per Fink, Head of Department )
Study ID Numbers: 20052
Study First Received: July 19, 2005
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00132197  
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Functional somatic symptoms
Cognitive behavioral therapy
somatization disorder
SF-36
cost-effectiveness
Medically unexplained symptoms

Study placed in the following topic categories:
Mental Disorders
Somatoform Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009