Clinical Trial: A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities
Brief Summary:
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
Detailed Summary:
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 programm
Sponsor: University Hospital, Gentofte, Copenhagen
Current Primary Outcome: Symptom Checklist- 92 (SCL-92) [ Time Frame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Perceived Stress Scale (PSS-10) [ Time Frame: 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 ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Gentofte, Copenhagen
Dates:
Date Received: April 28, 2008
Date Started: April 2008
Date Completion:
Last Updated: August 18, 2011
Last Verified: April 2008
