Mindfulness-based Cognitive Therapy for Patients With Functional Disorders
Condition: Somatization Disorder; Functional Disorders; Bodily Distress Disorder
MeSH terms: Pathologic Processes; Somatoform Disorders; Neurasthenia
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness-Based Cognitive Therapy for Functional Disorders
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness-Based Cognitive Therapy; Somatization Disorder; Medically Unexplained Symptoms; Functional Somatic Symptoms; SF-36