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Completed

NCT Number: NCT01240395

Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

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.

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Key information

Conditions

Multiple Chemical Sensitivity Disorders of Environmental Origin Environmental Illness Hypersensitivity Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Danish Research Centre for Chemical Sensitivities

Ledreborg Allé 40, 2., Gentofte, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based cognitive therapy (MBCT)

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Danish Research Centre for Chemical Sensitivities

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2010
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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