Multiple Chemical SensitivityNCT01240395

Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

A study testing Mindfulness-based Cognitive Therapy (MBCT) in people with Multiple Chemical Sensitivity, run by The Danish Research Centre for Chemical Sensitivities at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness worry, quality of life, and illness perceptions in patients suffering from multiple chemical sensitivity (MCS). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Multiple Chemical Sensitivity
What is being tested?: Mindfulness-based Cognitive Therapy (MBCT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteDenmark
Study dates: Sep 2011to May 2013
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Fulfil Lacour's criteria for Multiple Chemical Sensitivity
Sign a written informed consent form

Who cannot join

A psychotic or bipolar disorder
An acute psychiatric disorder requiring other treatment
Suicidal ideations
Current alcohol or drug abuse
Previously engaged in a mindfulness programme

Trial locations and contacts

1 site in 1 country.

Denmark1 site

The Danish Research Centre for Chemical Sensitivities
Ledreborg Allé 40, 2., Gentofte, 2820

Other trials in Denmark

About this study

The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to which chemical exposures causes symptoms and the impact on daily life will be significantly improved in the MBCT treatment group as compared to the control group.

Conditions: Multiple Chemical Sensitivity
Being tested: Mindfulness-based Cognitive Therapy (MBCT)
Keywords: Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT
Medical subject headings: Multiple Chemical Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based Cognitive Therapy (MBCT)Behavioural
MBCT is partly based on the mindfulness-based stress reduction program (MBSR), developed by Jon Kabat-Zinn and colleagues, and partly on cognitive therapy for depression, the latter influence particularly expressed through the aspect of "decentering", meaning not accepting the content of thoughts as facts and not identifying with the thought. The MBCT programme in this study includes 2½ hours of training once a week for 9 weeks. In addition, participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.

Study groups in NCT01240395
Study group	Role	What they receive
MBCT intervention	Experimental	Not described Receives: Behavioral: Mindfulness-based Cognitive Therapy (MBCT)
Control group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
QEESI is a screening instrument for MCS.
Measured: 8 weeks, 1 year follow up

Secondary outcomes (8)

The brief illness perception questionnaire (Brief IPQ)
Measured: 8 weeks, 1 year follow up
The Five Facet Mindfulness Questionnaire (FFMQ)
Measured: 8 weeks, 1 year follow up
Symptom Check List 92 (SCL-92)
Measured: 8 weeks, 1 year follow up
The Perceived Stress Scale (PSS-10)
Measured: 8 weeks, 1 year follow up
The World Health Organization Quality of Life (WHOQOL-BREF)
Measured: 8 weeks, 1 year follow-up
Rumination-reflection questionnaire (RRQ)
Measured: 8 weeks, 1 year follow-up
Self compassion scale short form
Measured: 8 weeks, 1 year follow up
The role work functioning index
Measured: 8 weeks, 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011May 2013

First posted15 Nov 2010 (estimated)
Study startSep 2011
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple Chemical SensitivityStudies 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: 82 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240395
Sponsor's protocol ID: MBCT-MCS
Status last verified: Feb 2014
First submitted: 10 Nov 2010
Last updated: 19 Feb 2014
Results posted: No

Publications

Hauge CR, Bonde PJ, Rasmussen A, Skovbjerg S. Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial. Trials. 2012 Sep 27;13:179. doi: 10.1186/1745-6215-13-179.
PubMed 23016822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Chemical Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity
ClinicalTrials.gov ID: NCT01240395
Acronym / sponsor ID: MBCT-MCS
Conditions: Multiple Chemical Sensitivity
Keywords: Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (estimated)
Lead sponsor: The Danish Research Centre for Chemical SensitivitiesUniversity, hospital or other
Study start: Sep 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 15 Nov 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MBCT intervention	Experimental	Behavioral: Mindfulness-based Cognitive Therapy (MBCT)
Control group	No intervention	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Fulfil Lacour's criteria for Multiple Chemical Sensitivity
Sign a written informed consent form

Key exclusion criteria (5 listed)

A psychotic or bipolar disorder
An acute psychiatric disorder requiring other treatment
Suicidal ideations
Current alcohol or drug abuse
Previously engaged in a mindfulness programme

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 (MBCT)MBCT is partly based on the mindfulness-based stress reduction program (MBSR), developed by Jon Kabat-Zinn and colleagues, and partly on cognitive therapy for depression, the latter influence particularly expressed through the aspect of "decentering", meaning not accepting the content of thoughts as facts and not identifying with the thought. The MBCT programme in this study includes 2½ hours of training once a week for 9 weeks. In addition, participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.	Behavioural	MBCT intervention

Primary outcome

The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
Time frame: 8 weeks, 1 year follow up
QEESI is a screening instrument for MCS.

8 secondary outcomes

The brief illness perception questionnaire (Brief IPQ)
Time frame: 8 weeks, 1 year follow up
The Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 8 weeks, 1 year follow up
Symptom Check List 92 (SCL-92)
Time frame: 8 weeks, 1 year follow up
The Perceived Stress Scale (PSS-10)
Time frame: 8 weeks, 1 year follow up
The World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: 8 weeks, 1 year follow-up
Rumination-reflection questionnaire (RRQ)
Time frame: 8 weeks, 1 year follow-up
Self compassion scale short form
Time frame: 8 weeks, 1 year follow up
The role work functioning index
Time frame: 8 weeks, 1 year 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 19 Feb 2014.
Derived from this study: PubMed 23016822Hauge CR, Bonde PJ, Rasmussen A, Skovbjerg S. Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial. Trials. 2012 Sep 27;13:179. doi: 10.1186/1745-6215-13-179.

Related trials for Multiple Chemical Sensitivity

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Recruiting
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Idiopathic Environmental Intolerance
Active, not recruiting
Central Processing of Odour Stimuli in Patients With Functional Somatic Disorder, MCS or Post Covid Compared to Healthy Controls
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 (MBCT) in people with Multiple Chemical Sensitivity, run by The Danish Research Centre for Chemical Sensitivities 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 2 inclusion and 5 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 19 Feb 2014. 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?

The Quick Environmental Exposure and Sensitivity Inventory (QEESI) (time frame: 8 weeks, 1 year follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01240395, which also lists 1 linked publication.

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 19 Feb 2014.