Journal of Psychosomatic Research 79 (2015) 628634

Contents lists available at ScienceDirect

Journal of Psychosomatic Research

Mindfulness-based cognitive therapy (MBCT) for multiple chemical

sensitivity (MCS): Results from a randomized controlled trial with
1 year follow-up
Christian Riise Hauge a,, Alice Rasmussen b, Jacob Piet e, Jens Peter Bonde c, Claus Jensen d,
Antonia Sumbundu f, Sine Skovbjerg a
a
The Danish Research Centre for Chemical Sensitivities, Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, Ledreborg Alle 40, 2.th, Gentofte, 2820, Copenhagen,
Denmark
b
Psychiatric Centre, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark
c
Department of Occupational and Environmental Medicine, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark
d
Huge Consulting ApS, Denmark
e
The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark
f
Center for Mindfulness, Teaching and Supervision, Copenhagen, Denmark

a r t i c l e i n f o a b s t r a c t

Article history: Objective: Multiple chemical sensitivity (MCS) is a medically unexplained condition characterized by symptoms
Received 14 January 2015 from multiple organ systems following the perception of common odorants. The condition can cause severe func-
Received in revised form 29 June 2015 tional impairment for aficted individuals. The aim of this study was to assess the effects of mindfulness-based
Accepted 30 June 2015 cognitive therapy (MBCT) for individuals with MCS.
Methods: The intention-to-treat sample (ITT) included 69 individuals who had been randomized to either MBCT
Keywords:
or treatment as usual (TAU). The primary outcome measure was the Quick Environmental Exposure and
Mindfulness-based cognitive therapy
Multiple chemical sensitivity
Sensitivity Inventory (QEESI), which measures the following aspects of MCS: impact of MCS on daily life,
Randomized controlled trial symptoms, and reactions following chemical exposures. Secondary outcome measures included the Brief Illness
Perception Questionnaire (BIPQ) and the anxiety and depression subscales of the symptom checklist 92 (SCL-92).
Participants were assessed at baseline and post treatment, and at follow-up periods of 6- and 12-months.
Results: We found no effect of MBCT on the primary outcome, nor did we nd an effect on levels of depression or
anxiety. We did, however, nd positive changes in illness perceptions, which were sustained at 12-month follow-
up. Dropout rates were low, suggesting MBCT was well received and regarded as an acceptable intervention by
individuals with MCS.
Conclusions: Overall, these results suggest that MBCT does not change overall illness status in individuals with
MCS, but that MBCT positively changes emotional and cognitive representations. Possible explanations for
these results are discussed.
2015 Elsevier Inc. All rights reserved.

Introduction frequently reported among individuals who attribute symptoms to air-

Multiple chemical sensitivity (MCS), also known as idiopathic envi-
ronmental intolerance, is a medically unexplained condition character-
ized by symptomatic reactions to a perceived exposure to common
odorous chemicals, such as fragranced products and freshly printed
newspapers or magazines [2]. A distinct symptom pattern has not
been established, as symptoms typically vary between aficted individ-
uals, adding difculties to the formulation of a case denition. Neverthe-
less, symptoms from muscles and joints, extreme fatigue, upper airway
symptoms as well as symptoms originating from the central nervous
system (CNS), such as headache, dizziness, and confusion, are
Corresponding author.
E-mail address: christian.riise.hauge@regionh.dk (C.R. Hauge).
borne chemicals [3,17], and the condition is more commonly reported
in women than in men [2,6,7]. A Danish study from 2008 reported
that an estimated 0.5% of the adult Danish population experience symp-
toms attributed to airborne chemicals causing them to make adjust-
ments to both working life and social life [2], making MCS both a
relatively common and disabling problem. There are currently no
evidence-based treatments for MCS.
While the etiology and pathogenesis of MCS is still unclear, there is
no evidence to suggest that MCS is explained by a toxicological response
to common chemical odorants [1,9]. Instead, individual susceptibility
factors such as stress, subjective health complaints, and limited social
support have been found to be risk factors in the development of MCS
[10]. High degrees of symptomatic overlap and comorbidity between
MCS and other medically unexplained conditions, such as chronic

http://dx.doi.org/10.1016/j.jpsychores.2015.06.010
0022-3999/ 2015 Elsevier Inc. All rights reserved.
 C.R. Hauge et al. / Journal of Psychosomatic Research 79 (2015) 628634
fatigue syndrome and bromyalgia, have been reported in some studies
[5,15]. This raises the possibility that these conditions might be fueled
by common mechanisms, such as central sensitization, which has
been reported in individuals with MCS [32]. Studies from health psy-
chology have shown that illness perceptions are particularly inuential
in patients with medically unexplained symptoms in terms of number
of symptoms, seriousness, and chronicity [21], and compared with pa-
tients with similar physical disability with known organic pathology,
patients with medically unexplained symptoms have been found to ex-
press a higher degree of impairment in relation to carrying out day-to-
day roles and socializing [21]. Whether negative illness perceptions
uniquely contribute to the etiology of MCS is unknown, although
there is some evidence suggesting that individuals with MCS have
higher levels of modern health worries, which could theoretically con-
tribute to the amplication of bodily signals into symptoms [36].
In recent years, mindfulness-based interventions (MBIs), most
noteworthy mindfulness-based stress reduction (MBSR), have gained
popularity for a great variety of physical and mental conditions. Core
mindfulness themes include increasing present moment awareness
and enhancing acceptance of circumstances in one's life that may be
difcult or impossible to change, particularly with regard to chronic
physical illness and psychological suffering [16]. In a more recent devel-
opment, mindfulness has been combined with elements from cognitive
behavioral therapy, labeled mindfulness-based cognitive therapy
(MBCT), and has been used in the treatment for a variety of conditions,
such as health anxiety [34], symptoms of anxiety and depression among
cancer patients [37], chronic fatigue syndrome [26], as well as current
depression [19] and anxiety disorder [33]. A steadily increasing number
of studies have assessed the potential of MBIs for various medically un-
explained conditions. A recent meta-analysis, although lacking power,
reported a small to moderate positive effect of MBIs in reducing pain
and symptom severity and in reducing levels of anxiety and depression
[18]. Although more research is clearly needed, these ndings suggest
that MBIs have a promising potential in the treatment of these
conditions.
So far, only two studies have attempted to use an MBI in the treat-
ment of MCS. Our group conducted a pilot trial assessing the effects of
MBCT on psychological distress and illness perceptions in individuals
with MCS. The study did not nd a signicant effect of MBCT in terms
of reducing symptoms of anxiety or depression, however, a borderline
signicant effect was found on a global score of psychological distress,
and coupled with positive verbal feedback provided by several of the
participants it was concluded that a larger trial could be considered.
The second study included participants who presented with several
functional somatic syndromes, including MCS, and found that an
adapted MBSR program was associated with improved mental health
in addition to a statistically signicant within group reduction of somat-
ic symptoms [27]. In spite of these promising results, knowledge is still
lacking with respect to the potential of MBIs in reducing the perceived
sensitivity to odorous chemicals in individuals with MCS. This study
therefore aimed at assessing the potential of an adapted MBCT program
as a treatment for MCS.
Methods
The study had obtained approval from the regional ethics committee
and was carried out between September 2011 and May 2012 with
follow-up assessments continuing until May 2013.
Objectives
The primary objective of the study was to examine the effect of
MBCT on MCS. Secondary objectives included an assessment of whether
the MBCT intervention would be associated with more positive
cognitive and emotional illness perceptions along with reduced levels
of anxiety and depression. The study was conducted as a pragmatic
629
parallel groups design, comparing the MBCT program with treatment
as usual (TAU).
Participants
Participants were 69 individuals who were recruited by means of
referral from their general practitioner, through newspaper ads, and
by contacting individuals registered at the Danish Research Centre for
Chemical Sensitivities who had agreed to be contacted for future re-
search projects. Potential participants were interviewed by telephone
and screened for eligibility. To be eligible, participants had to be be-
tween 18 and 65 years of age, have signed a written informed consent
form, and fulll the following criteria for MCS: 1) The condition had
lasted for at least 6 months causing signicant lifestyle or functional im-
pairments, 2) there were reproducible CNS symptoms, 3) there was at
least one symptom from another organ system, 4) the symptoms oc-
curred in response to low levels of exposure to 5) multiple unrelated
chemicals, and 6) symptoms were improved or resolved when these
inciting chemicals were removed [11,17]. Exclusion criteria included
psychotic or bipolar disorders, suicidal ideations, drug or alcohol
abuse, and previous participation in an 8-week MBCT or MBSR program.
Participants who fullled the study criteria were then invited to
undergo a thorough assessment by means of the Schedules for Clinical
Assessment in Neuropsychiatry (SCAN), which is a semi-structured in-
terview designed to assess and classify psychopathology and behavior
associated with major psychiatric disorders, as well as containing a
comprehensive list of questions concerning somatic symptoms from
different organ systems. We were therefore able to assess the partici-
pants in terms of psychiatric comorbidity and the comorbid functional
somatic syndromes that could be identied by SCAN, using the
algorithms suggested by Fink and Schroder [12].
Sample size and power
Sample size was calculated on the basis of the life impact scale (LIS)
of the primary effect measure, the Quick Environmental Exposure and
Sensitivity Inventory (QEESI). A recent study evaluating a Danish trans-
lation of the QEESI showed that a sample consisting of individuals with
MCS had a mean score of 61.5 and a standard deviation of 24.3 on the LIS
[30,31]. We considered a 25% reduction of the LIS score to be a clinically
relevant improvement, which would amount to a Cohen's d of 0.61,
regarded as a moderate effect size. Our sample size estimation showed
that a total of 82 participants were required to detect such a difference
with a power of .80.
Randomization
Randomization was carried out in blocks of 1620 individuals, who
were randomized in equal numbers to MBCT or TAU. This was regarded
an adequate number of participants to start an MBCT group. The
randomization was conducted by a researcher who was not otherwise
involved in the trial. The random allocation sequence was generated
by means of a computer program, and the research team was blinded
to the allocation process. Following the randomization, the rst author
informed the participants about the results of the allocation by
telephone.
Measures
The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
has been developed as a screening instrument for MCS designed to facil-
itate history-taking from individuals who report chemical intolerance
[20]. We used the following 3 scales: Symptom Severity, Chemical
Exposures, and Life Impact, each containing 10 items and producing a
score ranging between 0 and 100. The Symptom Severity Scale covers
10 groups of symptoms, e.g. pain in muscles or joints, mucosal and
630 C.R. Hauge et al. / Journal of Psychosomatic Research 79 (2015) 628634
airway symptoms, and headaches. The Chemical Exposure Scale covers
reactions to various odors or chemicals, e.g. fragranced products and
evaporation from new furniture. The Life Impact Scale, which was the
primary outcome measure, asked the participants to consider how
much their sensitivities had affected various aspects of their lives such
as diet, ability to go to work or school, ability to be around others and
enjoy social activities, and relationships with spouse and family.
The Life Impact Scale can be regarded as tapping into a dimension of
MCS-specic quality of life in that it refers to behaviors and activities
that are frequently affected. The symptoms scale assesses commonly
experienced symptoms, while the chemical exposure scale asks about
responses to various odorous chemicals. A Danish translation of
QEESI has been evaluated in terms of internal consistency, testretest
reliability, sensitivity, and specicity, in order to establish normative
data [31]. The study included both a patient sample and a population-
based sample. The results from the patient sample showed median
values of 47.0, 82.1, and 65.0 on the Symptoms Scale, Chemical Intoler-
ance Scale, and Life Impact respectively, while the corresponding g-
ures from the general population were 11, 13, and 2, indicating high
discriminative validity. The psychometric properties of QEESI were
found to be satisfactory, which is in accord with other similar studies
[20,31].
The Brief Illness Perception Questionnaire (BIPQ) consists of 8 items
and is designed to measure patients' cognitive and emotional represen-
tations of their illness. Five items assess cognitive illness representa-
tions, 2 items assess emotional representations, and 1 item assesses
illness comprehensibility. The items are rated using a response scale of
0 to 10. BIPQ has been found to have good testretest reliability and
validity [4].
The Symptom-Check-List-92 (SCL-92) is a questionnaire intended for
measuring mental distress or affective distress. Only the anxiety and
depression subscales were included in this study. SCL-92 has been psy-
chometrically evaluated in a Danish population producing normative
data on mental distress in the Danish general population [23]. Further-
more, data on mental distress from other countries have been compared
and raw scores for caseness have been established in both Denmark and
the US [22], providing an opportunity to compare data from this study
with the normative data and raw score denitions for caseness in
Denmark.
Interventions: MBCT
Our 8-week intervention program was based on the MBCT program
[29], but in order to adapt it to individuals with MCS the CBT exercises
from the original MBCT program specically related to relapse of de-
pression were not taught as part of our program. In keeping with the
manual, the main treatment component was mindfulness exercises,
which included various forms of meditation and yoga. The purpose of
these exercises was to cultivate the ability to stay in the present with
full awareness, and to practice an attitude of acceptance of any sensa-
tion, pleasant or unpleasant, that arose in the present moment. With re-
gard to CBT elements in MBCT, we taught what could be considered
generic CBT exercises, with the purpose of promoting an understanding
of mindfulness by illuminating the nature of the mind and the processes
involved in thinking [8]. These included exercises demonstrating how
thoughts inuence feelings and how mood states in their own right in-
duce related thought patterns, as well as a brief meditation called the
three minute breathing space used as a means of coping with unpleas-
ant inner states and troublesome thoughts. The primary purpose of
these exercises was to promote a de-centered relationship to thoughts
and bodily sensations, i.e. I am not my thoughts or I am not my
symptoms [29].
Before commencing the program, all the participants were invited to
an individual session with the group therapist in order to get to know
them and answer questions about the program. At session 7, we
introduced psychoeducation on stress and strain, illustrated by the
exhaustion funnel as described by Williams and Penman [35].
The 8-week program was taught by two clinical psychologists who
had received formal training in teaching MBCT and MBSR from highly
recognized institutions, and who had several years' experience of
teaching MBIs to various clinical groups. Prior to the trial, a detailed
walkthrough of the modied MBCT curriculum was carried out in
order to ensure that all the program elements were delivered uniformly
throughout the trial.
Each participant in the MBCT group was invited to an individual in-
terview with the group instructor in order to discuss how mindfulness
could potentially benet them, taking into account their personal histo-
ry and current situation. Each instructor taught two 8-week groups. The
intervention consisted of 8 weekly sessions, each lasting 2 1/2 h, as well
as a day of silent retreat between the sixth and seventh sessions. Guided
instructions were provided on a CD for home practice, and hand outs
were administered after every session. Lastly, booster sessions at 1, 3,
and 6 months after the end of the 8-week program were offered to
the participants, which included mindfulness exercises in addition to a
short update by each of the participants.
TAU
The participants in the control group did not receive any formal treat-
ment regimen as part of the trial, but were informed that they should con-
tinue to receive usual care from their GP, specialist physician or other
health professional according to their needs [14]. While no restrictions
were put on the participants in terms of type of treatment they could en-
gage in for the duration of the trial, they were encouraged not to engage
in an equivalent 8-week mindfulness program.
Statistical analysis
Group afliation (MBCT or TAU) was concealed for the statistician
who carried out the statistical analyses. Continuous variables were
assessed for normality and homogeneity of variance. For the continuous
variables, 2 sample t-tests were conducted for assessment of group dif-
ferences at baseline. For ordinal variables, the Wilcoxon two-sample
rank sum test was used to assess group differences at baseline. For all
the variables an analysis was carried out to test whether there was a dif-
ference between the groups as well as for the effect of time. Further-
more, an interaction term was included to test if the potential effect of
time was equal in the 2 groups. A signicant group time interaction
would indicate the presence of a treatment effect. Because each partic-
ipant was measured at several time points, an ANOVA with repeated
measurements was used, thereby taking into account that the multiple
measures for each participant were not independent. BIPQ was mea-
sured on an ordinal scale, and the analyses were therefore carried out
by means of the general linear model with repeated measures, assum-
ing a multinomial distribution with cumulative logits to account for
the ordinal structure. All available data were included in the analysis
at each time point. Missing values were not imputed as the missing
data were assumed to be missing at random. Alpha level was set at
.05. All analyses were performed in SAS 9.3.
Results
Recruitment and participant ow
Fig. 1 describes the ow of participants through the trial. Recruit-
ment of participants took place between January 2011 and April 2012.
A total of 100 individuals agreed to undergo a telephone interview
and were screened for eligibility, whereof 25 individuals were ineligible
to participate, mostly (n = 17) due to not fullling the inclusion criteria.
One had been diagnosed with bipolar disorder and therefore met
the exclusion criteria for psychopathology, while 2 individuals had
 C.R. Hauge et al. / Journal of Psychosomatic Research 79 (2015) 628634 631

Enrollment Assessed for eligibility (n = 100)

Excluded (n = 25)
Inclusion criteria not met (n = 17)
Declined to participate (n = 5)
Exclusion criteria met (n = 3)

Randomized (n = 75)

Allocation
Allocated to MBCT (n = 38) Allocated to TAU (n = 37)
Received allocated intervention (n = 37) Received allocated intervention (n = 32)
Dropped out due to illness in the family ( n Dropped out due to loss of interest (n = 4)
= 1) Dropped out due to disappointment with
allocation (n = 1)

Follow-Up
Lost to follow-up at T2 (n = 2) Lost to follow-up at T2 (n = 1)
Dropped out due to hearing difficulties (n Dropped out due to loss of motivation (n =
=1) 1)
Dropped out due to difficulties filling in
questionnaire (n = 1) Lost to follow-up at T3 (n = 2)
Dropped out due to loss of motivation (n =
Lost to follow-up at T4 (n = 2)
2)
Dropped out due to loss of motivation (n =
1)

Unknown reason (n = 1)

Analyzed (n = 37) Analyzed (n = 32)

Fig. 1. CONSORT diagram.

previously undergone a similar 8-week mindfulness program and were somatic disorders, which could be identied by use of the SCAN inter-
therefore excluded from participation. A total of 75 participants fullled view. As previously described, all participants fullled predened
the eligibility criteria and gave informed consent to participate and criteria for MCS, which included experiencing signicant lifestyle or
subsequently underwent thorough pre-trial assessment by the SCAN. functional impairments due to MCS. Statistical analyses were carried
Six participants (5 controls and 1 intervention participant) withdrew out to assess group differences at baseline on every outcome measure.
prematurely prior to lling in questionnaires and could therefore not
be included in the statistical analyses. Reasons for withdrawing prema- Table 1
turely were loss of interest (n = 4), illness in the family (n = 1), and Baseline demographics and clinical characteristics.
disappointment with the allocation (n = 1). MBCT group (n = 37) Control group (n = 32)
In the MBCT group, 1 participant dropped out prior to commencing
n/% n/%
the mindfulness program due to illness in the family, while 1 participant
dropped out immediately following the course due to difculties lling Demographics
Age 52 (SD 8.6) 54 (SD 9.1)
in questionnaires. One participant dropped out after the rst session be-
Female 31 (83.8) 26 (81.3)
cause of hearing difculties. One participant discontinued treatment Employed or student 25 (67.6) 22 (68.8)
due to problems with smells elicited by the localities of the MBCT Unemployed 2 (5.4) 1 (3.1)
course, but agreed to continue to ll in questionnaires. A further 2 par- Disability pension or sick leave 4 (10.8) 3 (9.3)
ticipants were lost to follow-up at 12 months due to loss of motivation Higher educationa 12 (32) 16 (50)
Co-morbidity
(n = 1) and unknown reasons (n = 1). In the TAU group, a total of 3
Chronic fatigue 9 (25) 11 (34.4)
participants dropped out, 1 before post treatment assessment, and 2 Fibromyalgia 5 (10.8) 10 (31.2)
before the 6-month follow-up assessment. All dropouts were due to Irritable bowel syndrome 6 (16.2) 7 (21.9)
loss of motivation. Depression 3 (8.1) 4 (12.5)
Anxiety 4 (10.8) 3 (9.3)
In the MBCT group, the average class attendance was 7.2 and median
Clinically rated impairment
attendance was 8. Home practice was recorded as part of the trial. The Moderate 27 (72.9) 20 (62.5)
average time of daily home practice during the 8 week program was Severe 8 (21.6) 12 (37.5)
24 min. Illness duration (years) 15.4 (SD 11.7) 11.5 (SD 9.9)
Table 1 presents patient demographics, including baseline levels of a
Higher education was dened as at minimum having a bachelor's degree or
anxiety, depression, and fulllment of the criteria for various functional equivalent.
632 C.R. Hauge et al. / Journal of Psychosomatic Research 79 (2015) 628634

Table 2
Mean (SD) QEESI and SCL-92 scores from baseline to 12 month follow-up and between-group statistics.

Measure Group Baseline Post treatment 6 months 12 months Time treatment

F p

Life impact MBCT 52.5 (22.5) 52.4 (21.4) 53.3 (20.2) 51.1 (20.1) 0.13 .94
TAU 54.4 (22.2) 52.4 (22.4) 55.7 (24.6) 54.6 (23.5)
Symptoms MBCT 40.5 (20.3) 39.1 (20.1) 38.7 (17.4) 39.9 (19.7) 0.25 .86
TAU 43.3 (22.0) 43.4 (24.0) 41.7 (22.4) 42.8 (22.2)
Exposure MBCT 62.4 (19.2) 61.5 (20.2) 60.1 (21.3) 62.5 (20.7) 0.91 .44
TAU 67.4 (18.8) 62.6 (23.4) 67.0 (19.6) 67.5 (19.2)
Depression MBCT 0.68 (0.66) 0.75 (0.69) 0.71 (0.58) 0.67 (0.61) 0.33 .80
TAU 0.77 (0.75) 0.87 (0.85) 0.83 (0.76) 0.91 (0.81)
Anxiety MBCT 0.48 (0.48) 0.58 (0.58) 0.55 (0.60) 0.52 (0.52) 0.53 .66
TAU 0.61 (0.63) 0.72 (0.82) 0.57 (0.58) 0.64 (0.66)

MBCT (n = 37), TAU (n = 32). Abbreviations: QEESI = Quick Environmental and Exposure Inventory, SCL-92 = symptom checklist 92, MBCT = mindfulness based cognitive therapy, TAU
= treatment as usual.

Results showed no statistical differences on any of the outcome Secondary measures

measures, indicating that the randomization was successful.
Participant characteristics
Table 1 presents patient demographics, including baseline levels of
anxiety, depression, and fulllment of the criteria for various functional
somatic disorders, which could be identied by using the SCAN inter-
view. As previously described, all participants fullled predened
criteria for MCS, which included experiencing signicant lifestyle or
functional impairments due to MCS. Statistical analyses were carried
out to assess group differences at baseline on every outcome measure.
Results showed no statistical differences on any of the outcome
measures, indicating that the randomization was successful.
Primary outcome
The data analysis of the primary outcome measure (QEESI) showed
no signicant differences between the groups on the 3 measures of
MCS: for the Life Impact Scale (F = 0.13, p = .94), for the Symptom Se-
verity Scale: (F = 0.25, p = .86), and for the Chemical Exposure Scale:
(F = .91, p = .44). Descriptive statistics underpinned the results of
the signicance tests showing no change on Life Impact across the 4
time points (Table 2). On the symptoms scale there was a small trend
towards improvement for the MBCT group over time on the rst 3
time points (a drop of a total of 2 points on a scale from 0100), but
this trend was no longer present at 12-month follow-up. The exposure
scale showed a similar pattern.
SCL-92
Statistical analyses revealed no group differences between the 2
groups for anxiety: F 0.53, p = .66, or depression: F 0.33 p = .80, respec-
tively. Owing to the possibility that our results could be due to a oor ef-
fect, we selected a subgroup of participants with depression and anxiety
scores above cut-off for caseness (scl-depression 1.6 for women and
1.29 for men), as dened by Danish SCL-92 norms [22], and performed
a post hoc analysis with these participants. For depression, a total of 10
participants fullled these criteria (5 in the MBCT group and 5 in the
TAU group). The results showed no signicant treatment effect of
MBCT on depression for this subgroup, however, within-group change
scores from baseline to 12-month follow-up showed a drop in depres-
sion level corresponding to a large effect size (d = 1.8), for the MBCT
group, and a small to moderate effect for the TAU group (d = 0.42).
A similar post hoc analysis for anxiety was carried out, again using
the criteria for caseness reported by Olsen et al. [22] (scl-anxiety
1.15 for women and 0.94 for men). A total of 11 participants fullled
these criteria (MBCT = 4, TAU = 7). The analysis showed no signicant
group time interaction (F 0.53, p = .66) and no indications of a reduc-
tion of anxiety levels in the MBCT group (d = 0.17).
Brief Illness Perception Questionnaire (BIPQ)
With regard to the BIPQ, we found a borderline signicant
group time effect on the item assessing illness identity (X2 = 7.8,

Table 3
Mean (SD) BIPQ scores from baseline to 12 month follow-up, between group statistics and within group effect sizes.

Measure Group Baseline Post treatment 6 months 12 months Time treatment d

2
X p

Illness' effect on life MBCT 7.56 (2.17) 7.40 (2.43) 7.00 (2.36) 7.16 (2.37) 5.25 0.15 0.17
TAU 8.06 (1.95) 7.74 (2.32) 8.07 (2.03) 7.86 (1.90) 0.10
Course of illness MBCT 8.69 (1.79) 8.86 (1.99) 8.74 (2.12) 9.25 (1.24) 1.93 0.59 0.36
TAU 8.69 (1.91) 9.10 (1.49) 9.34 (1.37) 9.14 (1.41) 0.27
Sense of control MBCT 4.94 (2.76) 5.37 (2.67) 5.82 (2.33) 6.16 (2.44) 6.47 0.09 0.47
TAU 5.28 (2.69) 5.40 (3.14) 5.10 (2.68) 4.83 (2.66) 0.17
Effect of MBCT MBCT 6.00 (2.39) 5.59 (3.05) 5.68 (2.92) 5.57 (2.67) 1.0 0.80 0.17
TAU 6.17 (2.25) 5.15 (2.72) 5.38 (2.67) 5.46 (2.40) 0.31
Degree of symptoms MBCT 7.39 (2.13) 7.34 (2.21) 6.94 (2.19) 6.97 (2.15) 7.77 0.05* 0.20
TAU 7.63 (1.64) 7.97 (1.66) 8.14 (1.71) 7.79 (1.74) 0.09
Concern with illness MBCT 6.58 (2.75) 6.46 (2.66) 5.68 (2.41) 5.59 (2.42) 4.99 0.17** 0.38
TAU 7.25 (2.34) 7.03 (2.61) 7.31 (2.41) 6.83 (2.69) 0.17
Understanding of illness MBCT 6.20 (2.65) 6.77 (2.65) 6.97 (2.44) 6.97 (2.71) 3.83 0.28 0.29
TAU 6.41 (2.92) 6.10 (3.06) 7.00 (2.34) 6.21 (3.21) 0.07
Emotional effect MBCT 6.28 (2.50) 5.86 (2.69) 5.15 (2.48) 5.47 (2.26) 3.89 0.27 0.34
TAU 6.13 (2.69) 5.71 (2.78) 5.83 (2.87) 6.28 (2.78) 0.05

MBCT n = 37, TAU n = 32, *signicant group time interaction, **signicant effect by group. Effect size (Cohen's d) was calculated on pre intervention to 1 year follow-up change scores.
MBCT = mindfulness-based cognitive therapy, TAU = treatment as usual.
 C.R. Hauge et al. / Journal of Psychosomatic Research 79 (2015) 628634
p = 0.05), which asked participants to rate the degree to which they ex-
perienced symptoms due to MCS (see Table 3). A Cohen's d was calcu-
lated in order to estimate within group effect size. This suggested a
small treatment effect (d = .20) on illness identity in the MBCT group
and no such effect in the TAU group (d = .09) using the change scores
at baseline and 12-month follow-up. Moreover, the results showed a
borderline signicant main effect of group on the concern item (X2 =
3.7, p = 0.05), corresponding to a small to moderate within-group effect
size (d = 0.38) in the intervention group and a comparatively smaller
improvement in the TAU group (d = 0.17) at 12-month follow-up.
The largest within-group change as estimated by Cohen's d was found
on the control item, measuring personal control over MCS, revealing a
moderately perceived enhanced control (d = 0.47) in the interven-
tion while the TAU group, conversely, experienced a small reduction
in sense of control over the MCS (d = 0.17), again using the change
scores from baseline to 12-month follow-up. Finally, a test was conduct-
ed assessing the effects on a combined measure of illness perceptions
showing no signicant time group effect (F = 1.22, p = 0.31). Al-
though there were no signicant between group differences on the
combined measure of illness perceptions, within-group effect size esti-
mate revealed a small improvement on the combined measure of illness
perceptions in the MBCT group and (d = 0.30), indicating MCS was per-
ceived as gradually less threatening, while there was a converse tenden-
cy in the TAU group (d = 0.24), indicating that MCS was regarded as
increasingly threatening.
Discussion
This study is the rst RCT evaluating the effects of a modied MBCT
program compared to TAU for the treatment of MCS. The dropout level
in the MBCT group was low, and combined with positive verbal feed-
back from the participants this suggests that the intervention was well
received and acceptable for the participants in the trial. The data analy-
sis showed no signicant effect of MBCT on the primary outcome as
measured according to the following 3 aspects of MCS: life impact,
symptoms, and the degree to which chemical exposures were associat-
ed with unpleasant reactions. With respect to our secondary outcomes
the degree to which the participants attributed symptoms to MCS as
measured by the BIPQ became less pronounced with time in the inter-
vention group. The largest effect size was found on the personal control
item, indicating that the MBCT group experienced an enhanced sense of
personal control, while the TAU group, conversely, experienced a re-
duced sense of control over the MCS. The effect sizes were calculated
on baseline to 12-month follow-up change scores, indicating that treat-
ment effects were sustained at one year post treatment. Additionally,
we found a borderline signicant group effect of MBCT on the item mea-
suring concern with MCS. Within-group effect size estimates revealed
small-to-moderate treatment effects in the MBCT group on several of
the BIPQ items, as opposed to very limited effects in the TAU group.
With regard to anxiety and depression our results showed no statis-
tically signicant reductions in levels of depression or anxiety after
treatment with MBCT. Post hoc analyses were carried out for partici-
pants with symptoms corresponding to the cut-off level for depression
and anxiety in order to assess the potential efcacy of MBCT for individ-
uals with clinically signicant levels of depression and anxiety. No sta-
tistically signicant group differences between the MBCT and the TAU
control group were found, but the MBCT program was associated with
large reductions in depression scores corresponding to a large effect
size (Cohen's d) of 1.8, compared to moderate reductions of depression
in the TAU control group (Cohen's d = 0.42). With regard to anxiety, no
such benecial effects from the modied MBCT program were found.
The negative results on our primary outcome measure correspond
well with other recent studies assessing the effects of mindfulness-
based interventions for various chronic medically unexplained illnesses.
For example, a large randomized controlled trial on bromyalgia, a con-
dition widely represented among the participants in our trial, did not
633
nd an MBSR-based program to be superior to either a wait-list control
or an active control condition designed to match for nonspecic aspects
on health-related quality of life [28]. Moreover, a recently conducted
study with patients diagnosed with somatoform disorder and various
functional somatic syndromes compared mindfulness therapy with en-
hanced treatment as usual, and did not nd a difference between the
mindfulness group and the enhanced treatment as usual group on a
measure of health-related quality of life at 15-month follow-up [13].
Similarly, a recent trial using MBCT to treat patients with medically un-
explained symptoms did not nd the intervention to be associated with
improvement in general health status, but did report improvement in
mental functioning [25]. The studies in question, which were high-
quality RCTs with participants who were symptomatically similar to
the participants in our trial, give reason to question the efcacy of
MBSR-based interventions in terms of reducing the symptom burden
in patients with chronic, medically unexplained syndromes.
Although the main results from this trial are negative, the results
also suggest that MBCT could be considered a helpful and acceptable
supportive intervention for MCS that may positively affect illness per-
ceptions and thereby reduce the degree to which individuals feel threat-
ened or burdened by their MCS. It is noteworthy that although illness
perceptions were not targeted directly as part of our intervention, the
practice of mindfulness was nevertheless associated with positive
changes in cognitive and emotional representations of MCS, even
though the illness itself remained unchanged. Research conducted on
the implications of illness perceptions on health outcomes have
shown that negative illness perceptions are associated with poorer out-
comes on physical health and that challenging dysfunctional illness per-
ceptions may improve health outcomes [24]. Future studies will be
needed to determine whether a change in illness perceptions may also
inuence health outcomes in MCS, such as amount of sick leave. If this
is the case, then combining mindfulness with cognitive and psycho-
educational elements targeting unhelpful illness perceptions may be
the road ahead for improving coping and disease management for
individuals suffering from MCS.
This study has some important strengths. First, the study protocol
has been published [14]. Second, due to the study's RCT design, the
group differences which were observed on the secondary outcome
can likely be attributed to the intervention delivered and not external
factors such as regression towards the mean or maturation effects.
Third, this trial used skilled and well trained mindfulness instructors,
thereby reducing the likelihood that the negative results on the primary
outcome were due to inexperience or lack of competence on the part of
the instructors.
Some limitations must also be considered. First, we were unable to
recruit the intended number of participants required to detect a
predened group improvement of 25% on the Life Impact Scale, thereby
increasing the likelihood of making a type II error due to lack of power.
Although an underpowered study runs the risk of making a type II error,
it seems unlikely that this is the case in this study as our data did not in-
dicate statistically or clinically relevant improvements for either of the
two groups on the primary outcome. For the MBCT group, we saw a
very limited improvement on the symptoms and exposure scales on
the QEESI corresponding to a Cohen's d of 0.1 on the change scores
from baseline to 6-month follow-up, but this effect had subsided after
12 months. The signicance of these improvements is therefore small.
Another limitation is that we did not use an active control condition to
control for the attention received by the participants in the MBCT
group. Therefore we cannot rule out the possibility that any positive
changes in illness perceptions in the MBCT arm was due to the effect
of the attention received from the study instructors, to being part of a
treatment program or to factors related to being part of a group. More-
over, insofar as the participants were welcome to seek out other treat-
ments while being part of the study, we cannot rule out the possibility
that other treatments, over which we asserted no control, might have
inuenced the results. A nal limitation that should be mentioned is
634 C.R. Hauge et al. / Journal of Psychosomatic Research 79 (2015) 628634
that the study did not employ assessment of protocol adherence.
Although this study strove to follow the adapted MBCT manual closely,
assessing adherence to the protocol by means of video recordings or
independent assessors would have increased its internal validity.
Conclusion
The results from this RCT suggest that MBCT does not improve the
overall illness status in individuals with MCS, but MBCT positively
changes cognitive and emotional representations of MCS and hence re-
duces the degree to which MCS is perceived as threatening. The results
also suggest that for individuals with clinically elevated levels of
depression, MBCT might help to reduce such symptoms.
Conict of interest
The authors declare no conicts of interest.
Acknowledgments
The study is funded by the Danish Ministry of the Environment and
has received a research grant from Aage Bang's Foundation.
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