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

April 28, 2008
August 18, 2011
April 2008
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00669448 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Chemical Sensitivities
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
December 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00669448
ID H-C-2007-0088, H-C-2007-0088
No
The Danish Research Centre for Chemical Sensitivities, University Hospital, Gentofte
University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Sine Skovbjerg, cand.san The Danish Research Centre for Chemical Sensitivities
University Hospital, Gentofte, Copenhagen
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP