Treatment of Patients With Longstanding Unexplained Health Complaints
NCT ID: NCT00132197
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2005-04-30
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
20 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus County, Denmark
OTHER
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Per Fink, Dr.Med.Sc.
Role: STUDY_DIRECTOR
The Research Clinic for Functional Disorders, Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Per Fink
Aarhus C, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Schroder A, Rehfeld E, Ornbol E, Sharpe M, Licht RW, Fink P. Cognitive-behavioural group treatment for a range of functional somatic syndromes: randomised trial. Br J Psychiatry. 2012 Jun;200(6):499-507. doi: 10.1192/bjp.bp.111.098681. Epub 2012 Apr 26.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20052
Identifier Type: -
Identifier Source: org_study_id