Clinical trial NCT00669448: A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)
Official title: A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chemical Sensitivities
Keywords: Multiple chemical sensitivities
MCS
Mindfulness-based cognitive therapy
MBCT
Behavioural intervention
Stress
Illness perceptions
Pilot trial
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Symptom Checklist- 92 (SCL-92)
timeFrame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
measure: The subjective health complaints (SHC) inventory
timeFrame: Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
measure: The Brief Illness Perception Questionnaire (Brief IPQ)
timeFrame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: The Danish Research Centre for Chemical Sensitivities
Study officials:
affiliation: The Danish Research Centre for Chemical Sensitivities
name: Sine Skovbjerg, cand.san
role: PRINCIPAL_INVESTIGATOR
References: