Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

NCT00497185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-11-16

No results posted yet for this study

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.

Conditions

  • Somatization Disorder
  • Functional Disorders
  • Bodily Distress Disorder

Interventions

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.

Sponsors & Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

    collaborator OTHER_GOV
  • Aarhus University Hospital

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per Fink, DMSc · The Research Clinic for Functional Disorders, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-06-30
Completion
2010-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00497185 on ClinicalTrials.gov