Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness worry, quality of life, and illness perceptions in patients suffering from multiple chemical sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a possible symptom reduction is mediated by an increased level of mindfulness. The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to which chemical exposures causes symptoms and the impact on daily life will be significantly improved in the MBCT treatment group as compared to the control group.

Conditions
-----------------
Multiple Chemical Sensitivity

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based Cognitive Therapy (MBCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfil Lacour's criteria for Multiple Chemical Sensitivity Sign a written informed consent form Exclusion Criteria: A psychotic or bipolar disorder An acute psychiatric disorder requiring other treatment Suicidal ideations Current alcohol or drug abuse Previously engaged in a mindfulness programme

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT intervention<br> | Behavioral: Mindfulness-based Cognitive Therapy (MBCT)<br>* MBCT is partly based on the mindfulness-based stress reduction program (MBSR), developed by Jon Kabat-Zinn and colleagues, and partly on cognitive therapy for depression, the latter influence particularly expressed through the aspect of decentering, meaning not accepting the content of thoughts as facts and not identifying with the thought. The MBCT programme in this study includes 2½ hours of training once a week for 9 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quick Environmental Exposure and Sensitivity Inventory (QEESI) | QEESI is a screening instrument for MCS. | 8 weeks, 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The brief illness perception questionnaire (Brief IPQ) |  | 8 weeks, 1 year follow up | 
| The Five Facet Mindfulness Questionnaire (FFMQ) |  | 8 weeks, 1 year follow up | 
| Symptom Check List 92 (SCL-92) |  | 8 weeks, 1 year follow up | 
| The Perceived Stress Scale (PSS-10) |  | 8 weeks, 1 year follow up | 
| The World Health Organization Quality of Life (WHOQOL-BREF) |  | 8 weeks, 1 year follow-up | 
| Rumination-reflection questionnaire (RRQ) |  | 8 weeks, 1 year follow-up | 
| Self compassion scale short form |  | 8 weeks, 1 year follow up | 
| The role work functioning index |  | 8 weeks, 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple chemical sensitivities, MCS, Mindfulness-based cognitive therapy, MBCT