Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity
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|ClinicalTrials.gov Identifier: NCT01240395|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : February 19, 2014
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||Phase|
|Multiple Chemical Sensitivity||Behavioral: Mindfulness-based Cognitive Therapy (MBCT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|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|
- The Quick Environmental Exposure and Sensitivity Inventory (QEESI) [ Time Frame: 8 weeks, 1 year follow up ]QEESI is a screening instrument for MCS.
- 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 ]
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
|The Danish Research Centre for Chemical Sensitivities|
|Ledreborg Allé 40, 2., Gentofte, Denmark, 2820|