A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669448
• Other study ID #: ID H-C-2007-0088
• Secondary ID: H-C-2007-0088
• Status: Completed
• Phase: N/A
• First received: April 28, 2008
• Last updated: August 18, 2011
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Chemical Sensitivities
• Multiple Chemical Sensitivity

Intervention

Behavioral:
• Minfulness-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.

Locations

Country	Name	City	State
Denmark	The Danish Research Centre for Chemical Sensitivities	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Checklist- 92 (SCL-92)		Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course	No
Secondary	Perceived Stress Scale (PSS-10)		Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course	No
Secondary	The subjective health complaints (SHC) inventory		Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course	No
Secondary	The Brief Illness Perception Questionnaire (Brief IPQ)		Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course	No