Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

Multiple Chemical Sensitivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240395
• Other study ID #: MBCT-MCS
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: February 17, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: The Danish Research Centre for Chemical Sensitivities
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Chemical Sensitivity

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.

Locations

Country	Name	City	State
Denmark	The Danish Research Centre for Chemical Sensitivities	Ledreborg Allé 40, 2.	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
The Danish Research Centre for Chemical Sensitivities

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Quick Environmental Exposure and Sensitivity Inventory (QEESI)	QEESI is a screening instrument for MCS.	8 weeks, 1 year follow up	No
Secondary	The brief illness perception questionnaire (Brief IPQ)		8 weeks, 1 year follow up	No
Secondary	The Five Facet Mindfulness Questionnaire (FFMQ)		8 weeks, 1 year follow up	No
Secondary	Symptom Check List 92 (SCL-92)		8 weeks, 1 year follow up	No
Secondary	The Perceived Stress Scale (PSS-10)		8 weeks, 1 year follow up	No
Secondary	The World Health Organization Quality of Life (WHOQOL-BREF)		8 weeks, 1 year follow-up	No
Secondary	Rumination-reflection questionnaire (RRQ)		8 weeks, 1 year follow-up	No
Secondary	Self compassion scale short form		8 weeks, 1 year follow up	No
Secondary	The role work functioning index		8 weeks, 1 year follow-up	No