Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497185
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2007-07-04
Brief Title:
Mindfulness-based Cognitive Therapy for Patients With Functional Disorders
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Mindfulness-based Cognitive Therapy for Patients With Functional Disorders A Randomized Controlled Trial
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 aim of the study is to examine the efficacy of Mindfulness-Based Cognitive Therapy MBCT in patients with functional disorders defined as severe Bodily Distress Disorder
Hypothesis MBCT can ameliorate the symptoms of FD defined as severe Bodily Distress Disorder and decrease health care utilization beyond the effect of shared care Patients treated with MBCT will function better physically and socially than patients treated with shared care at 12 months follow-up
Hypothesis MBCT can ameliorate the symptoms of FD defined as severe Bodily Distress Disorder and decrease health care utilization beyond the effect of shared care Patients treated with MBCT will function better physically and socially than patients treated with shared care at 12 months follow-up
Detailed Description:
Functional Disorders FD are conditions where patients complain of multiple medically unexplained physical symptoms FD defy the clinical picture of any conventionally defined disease and cannot adequately be supported by clinical or para-clinical findings The disorders are common in all medical settings both in primary and secondary care The conditions range from mild to severe and disabling they are costly for society due to the patients high health care use and the patients social and functional level is reduced There is no well-established effective pharmacological or psychotherapeutical treatment offer today
In randomized controlled trials cognitive behavioural treatment has shown to be effective for selected patient groups suffering from FD However only a few trials have been made especially concerning treatment of the most severe disorders
Randomized controlled trials on Mindfulness-Based Stress Reduction MBSR have shown mitigation of stress anxiety and dysphoria in a general population sample and reduction in total mood disturbances and stress symptoms in a medical population sample Furthermore RCTs in Mindfulness-Based Cognitive Therapy MBCT have demonstrated a 50 reduction of depression relapse for individuals who have experienced three or more previous episodes
We wish to examine the efficacy of MBCT in patients with functional disorders defined as severe Bodily Distress Disorder
In randomized controlled trials cognitive behavioural treatment has shown to be effective for selected patient groups suffering from FD However only a few trials have been made especially concerning treatment of the most severe disorders
Randomized controlled trials on Mindfulness-Based Stress Reduction MBSR have shown mitigation of stress anxiety and dysphoria in a general population sample and reduction in total mood disturbances and stress symptoms in a medical population sample Furthermore RCTs in Mindfulness-Based Cognitive Therapy MBCT have demonstrated a 50 reduction of depression relapse for individuals who have experienced three or more previous episodes
We wish to examine the efficacy of MBCT in patients with functional disorders defined as severe Bodily Distress Disorder
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