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

NCT ID: NCT00669448

Last Updated: 2011-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Multiple Chemical Sensitivities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Gentofte

Principal Investigators

Sine Skovbjerg, cand.san

Role: PRINCIPAL_INVESTIGATOR

The Danish Research Centre for Chemical Sensitivities

Locations

The Danish Research Centre for Chemical Sensitivities

Gentofte Municipality, , Denmark

Countries

Denmark

Other Identifiers

H-C-2007-0088

Identifier Type: -

Identifier Source: secondary_id

ID H-C-2007-0088

Identifier Type: -

Identifier Source: org_study_id