Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

This study has been completed.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00497185
First received: July 4, 2007
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

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 Intervention
Somatization Disorder
Functional Disorders
Bodily Distress Disorder
Behavioral: Mindfulness-Based Cognitive Therapy for Functional Disorders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-based Cognitive Therapy for Patients With Functional Disorders. A Randomized Controlled Trial

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Physical health measured by SF-36 Physical Component Summary [ Time Frame: End of treatment, 6 and 12 months' follow-up ] [ Designated as safety issue: No ]

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. [ Time Frame: End of treatment, 6 and 12 months' follow-up ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497185

Locations
Denmark
Per Fink
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Aarhus University Hospital
Investigators
Study Director: Per Fink, DMSc The Research Clinic for Functional Disorders, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00497185     History of Changes
Other Study ID Numbers: 200706
Study First Received: July 4, 2007
Last Updated: November 11, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Mindfulness-Based Cognitive Therapy
Somatization Disorder
Medically Unexplained Symptoms
Functional Somatic Symptoms
SF-36

Additional relevant MeSH terms:
Disease
Somatoform Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014