Mindfulness-based Cognitive Therapy for Patients With Functional Disorders

NCT00497185 | Completed

• 1 other identifier: 200706
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mindfulness-Based Cognitive Therapy; Somatization Disorder; Medically Unexplained Symptoms; Functional Somatic Symptoms; SF-36

Outcome Measures

Primary Outcomes (1)

• Physical health measured by SF-36 Physical Component Summary

  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.

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

Study Arms (2)

A

OTHER

Mindfulness-Based Cognitive Therapy

Behavioral: Mindfulness-Based Cognitive Therapy for Functional Disorders

B

NO INTERVENTION

Shared care: Treatment as usual augmented by psychiatric consultation intervention to optimise treatment in the present health care system.

Interventions

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.

A

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Per Fink

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Somatoform Disorders; Neurasthenia; Medically Unexplained Symptoms

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Per Fink, DMSc

  The Research Clinic for Functional Disorders, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

DK (1)