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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00669448
Enrollment
39
Registered
2008-04-30
Start date
2008-04-30
Completion date
2008-12-31
Last updated
2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Chemical Sensitivities

Keywords

Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT, Behavioural intervention, Stress, Illness perceptions, Pilot trial

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.

Interventions

BEHAVIORALMinfulness-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.

Sponsors

University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Symptom Checklist- 92 (SCL-92)Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course

Secondary

MeasureTime frame
Perceived Stress Scale (PSS-10)Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
The subjective health complaints (SHC) inventoryBaseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
The Brief Illness Perception Questionnaire (Brief IPQ)Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026