A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)

August 18, 2011 updated by: University Hospital, Gentofte, Copenhagen

A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities

OBJECTIVES

The objective is to evaluate the effect of an 8-week mindfulness-based cognitive therapy (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in individuals with self- reported multiple chemical sensitivities.

PARTICIPANTS

Participants will be recruited among respondents to a survey on the consequences of self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish Research Centre for Chemical Sensitivities.

DESIGN

The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as usual.

INTERVENTION

The MBCT programme includes 2½ hours of group training at the Psychiatric Centre, Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.

OUTCOME MEASURES

Effect of MBCT will be estimated from individual scores on psychometric scales

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND

Multiple chemical sensitivities is a collective term used to describe illness from exposure to common environ-mental agents. A recent Danish population-based cross sectional study reported that 27% of the respondents reported various symptoms from exposure to common environmental agents. In 19% of the respondents symptoms had led to behavioral changes and in 3.3% of the respondents to adjustments in either social life or occupational conditions, and in 0.5% to adjustments in both social life and occupational conditions. Multiple chemical sensitivities is not acknowledged as a clinical diagnose in Denmark and the Danish Healthcare System has no clinical guidelines for management of people who report this type of illness.

OBJECTIVES

To evaluate the effect of an 8-week mindfulness-based cognitive therapy (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in individuals with self- reported multiple chemical sensitivities.

PARTICIPANTS

Participants will be recruited among respondents to a survey on the consequences of self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish Research Centre for Chemical Sensitives.

DESIGN

The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as usual. Eligible participants (n= 42) stratified by occupational status (e.g. employed/not employed) will be randomized to either intervention (MBCT) or treatment as usual.

INTERVENTION

The MBCT programme includes 2½ hours of group training at the Psychiatric Centre, Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.

OUTCOME MEASURES

Effect of MBCT will be estimated from individual scores on the following psychometric scales: Symptom-Check List-92, The Brief Illness Perception Questionnaire, Perceived Stress Scale-10 and The Subjective Health Complaints-inventory. Estimations will be carried out at baseline, four weeks after start of MBCT programme, eight weeks after start of MBCT programme, and three months after ending the MBCT programme.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • The Danish Research Centre for Chemical Sensitivities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18 years,
  2. Currently living in Zealand,
  3. Self - reported adjustments of social life and/or occupational conditions due to symptoms related to inhalation of airborne chemicals,
  4. Registered at the Danish Research Centre for Chemical Sensitivities because of self-reported symptoms attributed to common chemical scents,
  5. Consulted the Al-lergy Clinic,
  6. Rigshospitalet between 1990 and 2006 because of self-reported symptoms related to exposures to common environmental agents,
  7. Informed consent

Exclusion Criteria:

  1. Severe depression
  2. Psychotic disorders
  3. Medical treatment with antianxiety agents and antidepressants
  4. Alcohol - or drug abuse
  5. Previous participation in a MBCT programme
  6. Lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom Checklist- 92 (SCL-92)
Time Frame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course
Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course

Secondary Outcome Measures

Outcome Measure
Time Frame
Perceived Stress Scale (PSS-10)
Time Frame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
The subjective health complaints (SHC) inventory
Time Frame: Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
The Brief Illness Perception Questionnaire (Brief IPQ)
Time Frame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Sine Skovbjerg, cand.san, The Danish Research Centre for Chemical Sensitivities

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID H-C-2007-0088
  • H-C-2007-0088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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