Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

NCT ID: NCT00497185

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-06-30

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.

Conditions

Somatization Disorder; Functional Disorders; Bodily Distress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Mindfulness-Based Cognitive Therapy

Group Type: OTHER

Mindfulness-Based Cognitive Therapy for Functional Disorders

Intervention Type: BEHAVIORAL

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.

B

Shared care: Treatment as usual augmented by psychiatric consultation intervention to optimise treatment in the present health care system.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Fink, DMSc

Role: STUDY_DIRECTOR

The Research Clinic for Functional Disorders, Aarhus University Hospital

Locations

Per Fink

Aarhus C, , Denmark

Countries

Denmark

Other Identifiers

200706

Identifier Type: -

Identifier Source: org_study_id