Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

February 17, 2014 updated by: Christian Riise Hauge, The Danish Research Centre for Chemical Sensitivities

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). Furthermore, a secondary objective is to evaluate whether a possible symptom reduction is mediated by an increased level of mindfulness.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
EXPERIMENTAL: MBCT intervention
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Danish Research Centre for Chemical Sensitivities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (ESTIMATE)

November 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBCT-MCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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