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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00669448
First received: April 28, 2008
Last updated: August 18, 2011
Last verified: April 2008
  Purpose

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


Condition Intervention
Multiple Chemical Sensitivities
Behavioral: Minfulness-based cognitive therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Symptom Checklist- 92 (SCL-92) [ Time Frame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course ] [ Designated as safety issue: No ]
  • The subjective health complaints (SHC) inventory [ Time Frame: Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Minfulness-based cognitive therapy
    Mindfulness Based Cognitive Therapy (MBCT) is a group intervention that integrates elements from primarily Mindfulness-based Stress Reduction programme (MBSR)and cognitive therapy.The MBCT programme includes 2½ hours of training once a week for 8 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669448

Locations
Denmark
The Danish Research Centre for Chemical Sensitivities
Gentofte, Denmark, 2820
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Sine Skovbjerg, cand.san The Danish Research Centre for Chemical Sensitivities
  More Information

No publications provided

Responsible Party: The Danish Research Centre for Chemical Sensitivities, University Hospital, Gentofte
ClinicalTrials.gov Identifier: NCT00669448     History of Changes
Other Study ID Numbers: ID H-C-2007-0088, H-C-2007-0088
Study First Received: April 28, 2008
Last Updated: August 18, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
Multiple chemical sensitivities
MCS
Mindfulness-based cognitive therapy
MBCT
Behavioural intervention
Stress
Illness perceptions
Pilot trial

Additional relevant MeSH terms:
Multiple Chemical Sensitivity
Environmental Illness
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014