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Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

Primary Purpose

Multiple Chemical Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mindfulness-based Cognitive Therapy (MBCT)
Sponsored by
The Danish Research Centre for Chemical Sensitivities
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Chemical Sensitivity focused on measuring Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Danish Research Centre for Chemical Sensitivities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBCT intervention

Control group

Arm Description

Outcomes

Primary Outcome Measures

The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
QEESI is a screening instrument for MCS.

Secondary Outcome Measures

The brief illness perception questionnaire (Brief IPQ)
The Five Facet Mindfulness Questionnaire (FFMQ)
Symptom Check List 92 (SCL-92)
The Perceived Stress Scale (PSS-10)
The World Health Organization Quality of Life (WHOQOL-BREF)
Rumination-reflection questionnaire (RRQ)
Self compassion scale short form
The role work functioning index

Full Information

First Posted
November 10, 2010
Last Updated
February 17, 2014
Sponsor
The Danish Research Centre for Chemical Sensitivities
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1. Study Identification

Unique Protocol Identification Number
NCT01240395
Brief Title
Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Danish Research Centre for Chemical Sensitivities

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chemical Sensitivity
Keywords
Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBCT intervention
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Cognitive Therapy (MBCT)
Intervention Description
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 Outcome Measure Information:
Title
The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
Description
QEESI is a screening instrument for MCS.
Time Frame
8 weeks, 1 year follow up
Secondary Outcome Measure Information:
Title
The brief illness perception questionnaire (Brief IPQ)
Time Frame
8 weeks, 1 year follow up
Title
The Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame
8 weeks, 1 year follow up
Title
Symptom Check List 92 (SCL-92)
Time Frame
8 weeks, 1 year follow up
Title
The Perceived Stress Scale (PSS-10)
Time Frame
8 weeks, 1 year follow up
Title
The World Health Organization Quality of Life (WHOQOL-BREF)
Time Frame
8 weeks, 1 year follow-up
Title
Rumination-reflection questionnaire (RRQ)
Time Frame
8 weeks, 1 year follow-up
Title
Self compassion scale short form
Time Frame
8 weeks, 1 year follow up
Title
The role work functioning index
Time Frame
8 weeks, 1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Danish Research Centre for Chemical Sensitivities
City
Ledreborg Allé 40, 2.
State/Province
Gentofte
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23016822
Citation
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.
Results Reference
derived

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Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

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