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Trial record 29 of 293 for:    "Somatoform Disorder"

Treatment of Patients With Longstanding Unexplained Health Complaints

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00132197
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : November 16, 2011
Sponsor:
Collaborators:
Aarhus County, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.


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Study Type : Interventional  (Clinical Trial)
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 : April 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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.


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00132197     History of Changes
Other Study ID Numbers: 20052
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
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Somatoform Disorders
Mental Disorders