Somatization DisorderNCT00497185
Mindfulness-based Cognitive Therapy for Patients With Functional Disorders
A study testing Mindfulness-Based Cognitive Therapy for Functional Disorders in people with Somatization Disorder and Functional Disorders, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Somatization Disorder, Functional Disorders, Bodily Distress Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy for Functional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2007to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-based Cognitive Therapy for Patients With Functional Disorders. A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Mindfulness-Based Cognitive Therapy for Functional Disorders
- Keywords
- Mindfulness-Based Cognitive Therapy, Somatization Disorder, Medically Unexplained Symptoms, Functional Somatic Symptoms, SF-36
- Medical subject headings
- Somatoform Disorders, Neurasthenia, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy for Functional DisordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Mindfulness-Based Cognitive Therapy Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health measured by SF-36 Physical Component Summary
Measured: 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.
Measured: End of treatment, 6 and 12 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatization DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Per Fink, DMSc, Study director, The Research Clinic for Functional Disorders, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497185
- Sponsor's protocol ID
- 200706
- Status last verified
- Nov 2011
- First submitted
- 4 Jul 2007
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Cognitive Therapy for Patients With Functional Disorders. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00497185
- Acronym / sponsor ID
- 200706
- Keywords
- Mindfulness-Based Cognitive Therapy, Somatization Disorder, Medically Unexplained Symptoms, Functional Somatic Symptoms, SF-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Aarhus University Hospital
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Behavioral: Mindfulness-Based Cognitive Therapy for Functional DisordersMindfulness-Based Cognitive Therapy |
| B | No intervention | –Shared care: Treatment as usual augmented by psychiatric consultation intervention to optimise treatment in the present health care system. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive Therapy for Functional DisordersMindfulness-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. | Behavioural | A |
Primary outcome
Physical health measured by SF-36 Physical Component Summary
Time frame: End of treatment, 6 and 12 months' follow-up
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Fink, DMSc study director
The Research Clinic for Functional Disorders, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy for Functional Disorders in people with Somatization Disorder and Functional Disorders, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical health measured by SF-36 Physical Component Summary (time frame: End of treatment, 6 and 12 months' follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.