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Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240395
First Posted: November 15, 2010
Last Update Posted: February 19, 2014
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.
Information provided by (Responsible Party):
Christian Riise Hauge, The Danish Research Centre for Chemical Sensitivities
  Purpose

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 Intervention
Multiple Chemical Sensitivity Behavioral: Mindfulness-based Cognitive Therapy (MBCT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Christian Riise Hauge, The Danish Research Centre for Chemical Sensitivities:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 82
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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 Submitted: November 10, 2010
First Posted: November 15, 2010
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