Clinical trial NCT00497185: Mindfulness-based Cognitive Therapy for Patients With Functional Disorders
Official title: Mindfulness-based Cognitive Therapy for Patients With Functional Disorders. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatization Disorder
Functional Disorders
Bodily Distress Disorder
Keywords: Mindfulness-Based Cognitive Therapy
Somatization Disorder
Medically Unexplained Symptoms
Functional Somatic Symptoms
SF-36
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Aarhus University Hospital
First posted: 2007-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Functional disorder defined as Bodily Distress Disorder, severe
* Moderate to severe impairment
* The disorder's functional component can easily be separated from a coexisting well-defined physical disease
* No lifetime-diagnosis of psychosis, bipolar affective disorder, or depression with psychotic symptoms
* Age 20-50 years
* Patients of Scandinavian origin, who understand, read, write, and speak Danish

Exclusion Criteria:

* No informed consent
* An acute psychiatric disorder demanding other treatment, or if the patient is suicidal
* Abuse of narcotics or alcohol or (non-prescribed) medicine
* Pregnancy

Primary outcomes:
measure: Physical health measured by SF-36 Physical Component Summary
timeFrame: End of treatment, 6 and 12 months' follow-up
Secondary outcomes:
measure: 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.
timeFrame: End of treatment, 6 and 12 months' follow-up
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Per Fink
Study officials:
affiliation: The Research Clinic for Functional Disorders, Aarhus University Hospital
name: Per Fink, DMSc
role: STUDY_DIRECTOR
References: