Multiple Chemical Sensitivities Clinical Trial
Official title:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment