A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)
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Purpose
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
| Condition | Intervention |
|---|---|
|
Multiple Chemical Sensitivities |
Behavioral: Minfulness-based cognitive therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities |
- 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 ]
- 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 ]
| Enrollment: | 39 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
-
Behavioral: Minfulness-based cognitive therapy
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years,
- Currently living in Zealand,
- Self - reported adjustments of social life and/or occupational conditions due to symptoms related to inhalation of airborne chemicals,
- Registered at the Danish Research Centre for Chemical Sensitivities because of self-reported symptoms attributed to common chemical scents,
- Consulted the Al-lergy Clinic,
- Rigshospitalet between 1990 and 2006 because of self-reported symptoms related to exposures to common environmental agents,
- Informed consent
Exclusion Criteria:
- Severe depression
- Psychotic disorders
- Medical treatment with antianxiety agents and antidepressants
- Alcohol - or drug abuse
- Previous participation in a MBCT programme
- Lack of informed consent
Contacts and Locations| Denmark | |
| The Danish Research Centre for Chemical Sensitivities | |
| Gentofte, Denmark, 2820 | |
| Principal Investigator: | Sine Skovbjerg, cand.san | The Danish Research Centre for Chemical Sensitivities |
More Information
No publications provided
| Responsible Party: | The Danish Research Centre for Chemical Sensitivities, University Hospital, Gentofte |
| ClinicalTrials.gov Identifier: | NCT00669448 History of Changes |
| Other Study ID Numbers: | ID H-C-2007-0088, H-C-2007-0088 |
| Study First Received: | April 28, 2008 |
| Last Updated: | August 18, 2011 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by University Hospital, Gentofte, Copenhagen:
|
Multiple chemical sensitivities MCS Mindfulness-based cognitive therapy MBCT |
Behavioural intervention Stress Illness perceptions Pilot trial |
Additional relevant MeSH terms:
|
Multiple Chemical Sensitivity Environmental Illness Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013