Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00497185

Collaborator

The Ministry of Science, Technology and Innovation, Denmark (Other), Aarhus University Hospital (Other)

150

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Somatization Disorder Functional Disorders Bodily Distress Disorder	Behavioral: Mindfulness-Based Cognitive Therapy for Functional Disorders	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mindfulness-based Cognitive Therapy for Patients With Functional Disorders. A Randomized Controlled Trial

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: A 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.

Arm

Intervention/Treatment

Other: A

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.

Outcome Measures

Primary Outcome Measures

Physical health measured by SF-36 Physical Component Summary [End of treatment, 6 and 12 months' follow-up]

Secondary Outcome Measures

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. [End of treatment, 6 and 12 months' follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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