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

Primary Purpose

Multiple Chemical Sensitivities

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Minfulness-based cognitive therapy
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Chemical Sensitivities focused on measuring Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT, Behavioural intervention, Stress, Illness perceptions, Pilot trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Danish Research Centre for Chemical Sensitivities

Outcomes

Primary Outcome Measures

Symptom Checklist- 92 (SCL-92)

Secondary Outcome Measures

Perceived Stress Scale (PSS-10)
The subjective health complaints (SHC) inventory
The Brief Illness Perception Questionnaire (Brief IPQ)

Full Information

First Posted
April 28, 2008
Last Updated
August 18, 2011
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00669448
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chemical Sensitivities
Keywords
Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT, Behavioural intervention, Stress, Illness perceptions, Pilot trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Minfulness-based cognitive therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Checklist- 92 (SCL-92)
Time Frame
Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Time Frame
Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
Title
The subjective health complaints (SHC) inventory
Time Frame
Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sine Skovbjerg, cand.san
Organizational Affiliation
The Danish Research Centre for Chemical Sensitivities
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Danish Research Centre for Chemical Sensitivities
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

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

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