NCT01240395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

November 10, 2010

Last Update Submit

February 17, 2014

Conditions

Multiple Chemical Sensitivity

Keywords

Multiple chemical sensitivitiesMCSMindfulness-based cognitive therapyMBCT

Outcome Measures

Primary Outcomes (1)

  • The Quick Environmental Exposure and Sensitivity Inventory (QEESI)

    QEESI is a screening instrument for MCS.

    8 weeks, 1 year follow up

Secondary Outcomes (8)

  • The brief illness perception questionnaire (Brief IPQ)

    8 weeks, 1 year follow up

  • The Five Facet Mindfulness Questionnaire (FFMQ)

    8 weeks, 1 year follow up

  • Symptom Check List 92 (SCL-92)

    8 weeks, 1 year follow up

  • The Perceived Stress Scale (PSS-10)

    8 weeks, 1 year follow up

  • The World Health Organization Quality of Life (WHOQOL-BREF)

    8 weeks, 1 year follow-up

  • +3 more secondary outcomes

Study Arms (2)

MBCT intervention

EXPERIMENTAL
Behavioral: Mindfulness-based Cognitive Therapy (MBCT)

Control group

NO INTERVENTION

Interventions

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.

MBCT intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfil Lacour's criteria for Multiple Chemical Sensitivity
  • Sign a written informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish Research Centre for Chemical Sensitivities

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

Location

Related Publications (1)

  • Hauge CR, Bonde PJ, Rasmussen A, Skovbjerg S. Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial. Trials. 2012 Sep 27;13:179. doi: 10.1186/1745-6215-13-179.

    PMID: 23016822DERIVED

MeSH Terms

Conditions

Multiple Chemical Sensitivity

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Environmental IllnessHypersensitivityImmune System DiseasesDisorders of Environmental Origin

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc psychology

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 15, 2010

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

DK(1)