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Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christian Riise Hauge, The Danish Research Centre for Chemical Sensitivities
ClinicalTrials.gov Identifier:
NCT01240395
First received: November 10, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • The Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 8 weeks, 1 year follow up ] [ Designated as safety issue: No ]
  • Symptom Check List 92 (SCL-92) [ Time Frame: 8 weeks, 1 year follow up ] [ Designated as safety issue: No ]
  • The Perceived Stress Scale (PSS-10) [ Time Frame: 8 weeks, 1 year follow up ] [ Designated as safety issue: No ]
  • The World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: 8 weeks, 1 year follow-up ] [ Designated as safety issue: No ]
  • Rumination-reflection questionnaire (RRQ) [ Time Frame: 8 weeks, 1 year follow-up ] [ Designated as safety issue: No ]
  • Self compassion scale short form [ Time Frame: 8 weeks, 1 year follow up ] [ Designated as safety issue: No ]
  • The role work functioning index [ Time Frame: 8 weeks, 1 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: September 2011
Estimated Study Completion Date: May 2013
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by The Danish Research Centre for Chemical Sensitivities

Additional 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
Study First Received: November 10, 2010
Last Updated: April 8, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on June 13, 2013