Mindfulness-based Cognitive Therapy for Patients With Functional Disorders
|ClinicalTrials.gov Identifier: NCT00497185|
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : November 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Somatization Disorder Functional Disorders Bodily Distress Disorder||Behavioral: Mindfulness-Based Cognitive Therapy for Functional Disorders||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness-based Cognitive Therapy for Patients With Functional Disorders. A Randomized Controlled Trial|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2010|
Mindfulness-Based Cognitive Therapy
Behavioral: Mindfulness-Based Cognitive Therapy for Functional Disorders
Mindfulness-based cognitive therapy: A manualized program will be delivered by two instructors who are experienced cognitive therapists in eight weekly 3½-hour group training sessions and one follow-up session after a month involving up to 12 patients with somatoform disorders. The patients must be willing and able to attend and devote up to 1 hour per day for homework.
The therapy is compared with a group of controls receiving shared care defined as: Treatment as usual augmented by psychiatric consultation intervention: The patients are offered a psychiatric consultation after the assessment interview. It is the aim to optimise treatment in the present health care system.
No Intervention: B
Shared care: Treatment as usual augmented by psychiatric consultation intervention to optimise treatment in the present health care system.
- Physical health measured by SF-36 Physical Component Summary [ Time Frame: End of treatment, 6 and 12 months' follow-up ]
- 1. Social functioning, emotional disorders, coping: Sub-scales from SF-36, WHO-DAS II, CSQ, SCL, Whiteley-7, lifestyle factors, mindfulness scales. 2. Health care use: Data from national registers. [ Time Frame: End of treatment, 6 and 12 months' follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497185
|Aarhus C, Denmark, 8000|
|Study Director:||Per Fink, DMSc||The Research Clinic for Functional Disorders, Aarhus University Hospital|