Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

Somatization Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497185
• Other study ID #: 200706
• Status: Completed
• Phase: N/A
• First received: July 4, 2007
• Last updated: November 11, 2011
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bodily Distress Disorder
• Disease
• Functional Disorders
• Pathologic Processes
• Somatization Disorder
• Somatoform Disorders

Intervention

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.

Locations

Country	Name	City	State
Denmark	Per Fink	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical health measured by SF-36 Physical Component Summary		End of treatment, 6 and 12 months' follow-up	No
Secondary	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	No

External Links

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