Viewing Study NCT00132197



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Study NCT ID: NCT00132197
Status: COMPLETED
Last Update Posted: 2011-11-16
First Post: 2005-07-19

Brief Title: Treatment of Patients With Longstanding Unexplained Health Complaints
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

Official Title: Treatment of Patients With Chronic Functional Disorders A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care
Status: COMPLETED
Status Verified Date: 2011-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None