Multiple Chemical SensitivitiesNCT00669448
A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)
A study testing Minfulness-based cognitive therapy in people with Multiple Chemical Sensitivities, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Chemical Sensitivities
- What is being tested?
- Minfulness-based cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Danish Research Centre for Chemical Sensitivities
Gentofte Municipality, 2820
About this study
Official title: A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities
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.
Read more
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
Read the 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
- Being tested
- Minfulness-based cognitive therapy
- Keywords
- Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT, Behavioural intervention, Stress, Illness perceptions, Pilot trial
- Medical subject headings
- Multiple Chemical Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minfulness-based cognitive therapyBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Checklist- 92 (SCL-92)
Measured: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course
Secondary outcomes (3)
Perceived Stress Scale (PSS-10)
Measured: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
The subjective health complaints (SHC) inventory
Measured: Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
The Brief Illness Perception Questionnaire (Brief IPQ)
Measured: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Chemical SensitivitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Sine Skovbjerg, cand.san, Principal investigator, The Danish Research Centre for Chemical Sensitivities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669448
- Sponsor's protocol ID
- ID H-C-2007-0088
- Other IDs
- H-C-2007-0088
- Status last verified
- Apr 2008
- First submitted
- 28 Apr 2008
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities
- ClinicalTrials.gov ID
- NCT00669448
- Acronym / sponsor ID
- ID H-C-2007-0088
- Conditions
- Multiple Chemical Sensitivities
- Keywords
- Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT, Behavioural intervention, Stress, Illness perceptions, Pilot trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- Severe depression
- Psychotic disorders
- Medical treatment with antianxiety agents and antidepressants
- Alcohol - or drug abuse
- Previous participation in a MBCT programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minfulness-based cognitive therapyMindfulness 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. | Behavioural | – |
Primary outcome
Symptom Checklist- 92 (SCL-92)
Time frame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course
3 secondary outcomes
Perceived Stress Scale (PSS-10)
Time frame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course
The subjective health complaints (SHC) inventory
Time frame: Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
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Central Processing of Odour Stimuli in Patients With Functional Somatic Disorder, MCS or Post Covid Compared to Healthy Controls
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sine Skovbjerg, cand.san principal investigator
The Danish Research Centre for Chemical Sensitivities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minfulness-based cognitive therapy in people with Multiple Chemical Sensitivities, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Checklist- 92 (SCL-92) (time frame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.