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Completed

NCT Number: NCT00497185

Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

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.

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Key information

Conditions

Somatization Disorder Bodily Distress Disorder Functional Disorders Medically Unexplained Symptoms Mental Disorders Neurasthenia Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Per Fink

Aarhus C, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy for Functional Disorders

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.

Primary outcomes

  1. Physical health measured by SF-36 Physical Component Summary

    Time frame: End of treatment, 6 and 12 months' follow-up

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jul 6, 2007
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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