We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01240395
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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). 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.


Condition or disease Intervention/treatment
Multiple Chemical Sensitivity Behavioral: Mindfulness-based Cognitive Therapy (MBCT)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
No Intervention: Control group


Outcome Measures

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


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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240395


Locations
Denmark
The Danish Research Centre for Chemical Sensitivities
Ledreborg Allé 40, 2., Gentofte, Denmark, 2820
Sponsors and Collaborators
The Danish Research Centre for Chemical Sensitivities
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Riise Hauge, MSc psychology, The Danish Research Centre for Chemical Sensitivities
ClinicalTrials.gov Identifier: NCT01240395     History of Changes
Other Study ID Numbers: MBCT-MCS
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Christian Riise Hauge, The Danish Research Centre for Chemical Sensitivities:
Multiple chemical sensitivities
MCS
Mindfulness-based cognitive therapy
MBCT

Additional relevant MeSH terms:
Hypersensitivity
Multiple Chemical Sensitivity
Immune System Diseases
Environmental Illness
Disorders of Environmental Origin