Regular Article

Psychother Psychosom 2017;86:241–253 Received: May 17, 2016

Accepted after revision: March 7, 2017
DOI: 10.1159/000470847
Published online: June 24, 2017

Comparing the Effects of Mindfulness-Based

Cognitive Therapy and Sleep Psycho-Education
with Exercise on Chronic Insomnia: A Randomised
Controlled Trial
Samuel Yeung-shan Wong h De-xing Zhang h Carole Chi-kwan Li b
     

Benjamin Hon-kei Yip h Dicken Cheong-chun Chan h Yuet-man Ling c

     

Cola Siu-lin Lo d Doris Mei-sum Woo e Yu-ying Sun h Helen Ma f

       

Winnie Wing-sze Mak g Ting Gao h Tatia Mei-chun Lee a Yun-kwok Wing i

       

a
Laboratory of Neuropsychology, The University of Hong Kong, b Department of Clinical Psychology, Tseung Kwan
   

O Hospital, c New Life Psychiatric Rehabilitation Association, d Department of Clinical Psychology, Castle Peak
   

Hospital, e Division of Clinical Psychology, Woo Mei Sum Psychological Service, f Hong Kong Centre for Mindfulness,
   

g
Department of Psychology, h JC School of Public Health and Primary Care, and i Department of Psychiatry,
     

The Chinese University of Hong Kong, Hong Kong, SAR, China

Keywords the Insomnia Severity Index (ISI). Secondary outcomes in-

Mindfulness-based cognitive therapy · Primary chronic
insomnia · Sleep · Intervention · Primary health care ·
Adult · Chinese population
Abstract
Background: Mindfulness-based cognitive therapy (MBCT)
is a potential treatment for chronic insomnia. We evaluated
the efficacy of MBCT for insomnia (MBCT-I) by comparing it
with a sleep psycho-education with exercise control (PEEC)
group. Methods: Adults with chronic primary insomnia (n =
216) were randomly allocated to the MBCT-I or PEEC group.
The MBCT-I included mindfulness and psycho-education
with cognitive and behavioural components under cogni-
tive behavioural therapy for insomnia. PEEC included psy-
cho-education of sleep hygiene and stimulus control, and
exercises. Any change in insomnia severity was measured by
cluded sleep parameters measured by a sleep diary, health
service utilisation, absence from work and mindfulness mea-
sured by the Five Facet Mindfulness Questionnaire. Results:
The ISI score significantly decreased in the MBCT-I group
compared with the PEEC group at 2 months (i.e., post-inter-
vention) (p = 0.023, effect size [95% CI] –0.360 [–0.675,
–0.046]) but not at 5 or 8 months. Treatment response rates
and remission rates based on the ISI cut-off scores were not
significantly different between groups. Wake time after
sleep onset (WASO) was less in the MBCT-I group at 2 and 5
months. At 8 months, both groups showed a reduced ISI
score, sleep onset latency and WASO, and increased sleep
efficiency and total sleep time; however, no group differenc-
es were seen. Other outcome measures did not significantly
improve in either group. Conclusions: Long-term benefits
were not seen in MBCT-I when compared with PEEC, al-
though short-term benefits were seen. © 2017 S. Karger AG, Basel
165.123.34.86 - 7/3/2017 5:07:05 PM

© 2017 S. Karger AG, Basel Prof. Samuel Yeung-shan Wong

4/F, JC School of Public Health and Primary Care
University of Pennsylvania

Prince of Wales Hospital

E-Mail karger@karger.com
Shatin, NT, Hong Kong, SAR (China)
www.karger.com/pps
Downloaded by:

E-Mail yeungshanwong @ cuhk.edu.hk
 Introduction
Chronic insomnia is a significant public health prob-
lem due to its high prevalence [1–3], and its association
with disability, function impairment and high utilisation
of health services [4–9]. Current pharmaceutical treat-
ments have limitations due to the presence of side effects
and the potential for dependence and withdrawal [10].
Cognitive behavioural therapy for insomnia (CBT-I) –
usually including cognitive therapy, behavioural compo-
nents (stimulus control and sleep restriction), sleep hy-
giene, and/or relaxation, is an effective non-pharmaceu-
tical intervention for chronic insomnia [11]. Group-based
CBT-I, typically with 4–7 sessions and 4–10 participants
in each group [12–14], has a medium to large effect for
insomnia or conditions comorbid with insomnia as found
in a recent meta-analysis on 8 studies [14]. However, it is
also reported that not all patients accept or respond to
CBT-I or pharmacotherapy and patients can be vulnera-
ble to recurrence even if they respond well to short-term
therapy [15].
Mindfulness-based interventions (MBIs) have become
popular in recent years and are regarded as promising
treatments for various health problems including sleep
disturbance [16]. Mindfulness is defined as “awareness
that arises through paying attention on purpose, in the
present moment, non-judgmentally” [17]. Mindfulness-
based cognitive therapy (MBCT) and mindfulness-based
stress reduction (MBSR) are both empirical interventions
which are effective in improving the symptoms of a num-
ber of common health problems such as pain, stress, anx-
iety, and depression [18–20]. In both MBSR and MBCT,
a group size of 10–15 participants can often be accommo-
dated in 8 sessions with the introduction to mindfulness
concepts and practices such as body scan, mindful sitting,
walking and breathing, and exercises. Participants can
also integrate formal and informal mindfulness practice
into their daily lives to maintain long-term practice. Pre-
sleep arousal and worry are common among poor sleep-
ers [21]. Studies suggest that mindfulness might improve
sleep and decrease pre-sleep arousal and worry and re-
frame sleep-interfering cognitive processes, through con-
centrating on the present moment and letting go of the
stressful, obsessive and intrusive thoughts, beliefs and
emotions [16, 22]. It leads to a “know awareness mind”
without interfering thoughts and feelings. Instead of
changing the thoughts themselves, it intends to change
one’s relationship with the thoughts [22]. With the com-
bination of both mindfulness and cognitive and behav-
ioural components, MBCT might be a potential treat-
242 Psychother Psychosom 2017;86:241–253
DOI: 10.1159/000470847
ment for insomnia without adverse effects. Previous stud-
ies have been conducted to evaluate the effectiveness of
MBIs in improving the sleep quality and reducing insom-
nia symptoms among patients with chronic conditions
co-morbid with sleep disturbance [23–33]. However, no
confirmative conclusions were drawn about the effective-
ness of MBIs, as shown in a systematic review of MBSR
on sleep disturbance [16]. And only a few randomised
controlled studies [34–37] have evaluated the effects of
MBIs among adults with chronic insomnia, although
most of them were limited by their study design including
small sample sizes (n = 30–60) [34–37], including adults
only in a certain age range [35, 36] or having a short fol-
low-up period [35–37]. As a result, although preliminary
promising findings favouring MBIs in improving sleep
quality or reducing insomnia severity were suggested
[34–37], studies with a larger sample size which are ade-
quately powered are needed to offer a more definitive
conclusion on the effectiveness of MBIs on chronic pri-
mary insomnia.
The current study aimed to evaluate the efficacy of
MBCT for insomnia (MBCT-I) in reducing insomnia se-
verity and improving other sleep parameters among
adults with diagnosed chronic primary insomnia by com-
paring it to sleep psycho-education with stretching exer-
cise. We hypothesised that patients in the MBCT-I group
would show greater effects in reducing insomnia severity,
sleep latency, time awake after sleep onset, and in increas-
ing sleep efficiency and total sleep time (TST) when com-
pared with a psycho-education with stretching exercise
control (PEEC) group for insomnia. We also hypothe-
sised that patients in the MBCT-I condition would have
a greater reduction in health service use than patients in
the PEEC group.
Methods
This was a single-blind randomised controlled trial with two
study arms: an MBCT-I programme and a PEEC group as the com-
parison group. The MBCT-I and PEEC lasted for 8 weeks and out-
come measures were collected at similar time points at baseline,
2 months (post-intervention), 5 months (3-month follow-up) and
8 months (6-month follow-up). This study was conducted in com-
pliance with the Code of Ethics of the Declaration of Helsinki. Eth-
ics approval was obtained from the Joint Chinese University of
Hong Kong – New Territories East Cluster Clinical Research Eth-
ics Committee before the conduction of the trial. The trial was
registered at chictr.org (identifier: ChiCTR-TRC-12002535).
Study Population and Recruitment
Participants were recruited from the community including pri-
mary care settings in Hong Kong through: (1) posters and leaflets
165.123.34.86 - 7/3/2017 5:07:05 PM
Wong/Zhang/Li/Yip/Chan/Ling/Lo/Woo/
University of Pennsylvania
Sun/Ma/Mak/Gao/Lee/Wing
Downloaded by:
distributed in General Outpatient Clinics or Family Medicine In-
tegrated Clinics of the New Territories East Cluster of the Hospital
Authority, as well as non-governmental organisations and com-
munity centres that provided services for people with chronic con-
ditions; (2) advertisements in local newspaper; (3) health interview
on local radio station; and (4) internal email to CUHK staff, stu-
dent and alumni. Only general information was advertised, and the
study was stated as evaluating two comparative interventions for
chronic insomnia.
The following inclusion criteria were used: (1) being 18 years of
age or older; (2) having chronic primary insomnia based on estab-
lished diagnostic criteria (DSM-IV and ICD-10 combined) that in-
cluded: (a) difficulties initiating and/or maintaining sleep, defined
as a sleep onset latency (SOL) and/or awake after sleep onset great-
er than 30 min, with a corresponding sleep time of less than 6.5 h at
least 3 nights per week as measured by daily sleep diaries; (b) dura-
tion of longer than 6 months; and (c) significant impairment of
daytime functioning (rating of ≥2 on item 5 of the Insomnia Sever-
ity Index [ISI]); (3) being able to understand Cantonese; (4) being
willing to attend the MBCT-I or PEEC programme; and (5) being
willing to discontinue their sleep medication for a period of 2 weeks
(washout period) prior to enrolling in the study or agreed to keep
the dosage and frequency of sleep medication unchanged during the
study period among those who regularly used sleep medication.
Exclusion criteria were: (1) illiterate participants as they would
not be able to complete the sleep diary and questionnaires; (2) psy-
chiatric and medical co-morbidities that were potentially life
threatening (e.g., suicidal ideation, terminal medical illness, psy-
chosis) or conditions expected to severely limit participation or ad-
herence (e.g., pregnancy); (3) presence of a progressive medical ill-
ness that was related to the onset and course of insomnia; (4) with
the use of the Patient Health Questionnaire (PHQ), had screened
positive for major depression (answered at least “more than half the
days” to Question 2a or 2b and 5 or more of Questions 2a–i), eating
disorder (answered “yes” to Questions 6a, b, and c), substance
abuse (answered “yes” to any of the Questions 10a–e) or anxiety
disorder (answered “yes” to Questions 3a–d and 4 or more of
Questions 4a–k [Panic Syndrome], or answered “more than half
the days” to Question 5a and 3 or more of Questions 5b–g [other
Anxiety Syndrome]), which has an overall accuracy of 85–88%, sen-
sitivity of 75–100% and specificity of 86–100% [38–40]; (5) pres-
ence of psychotic symptoms or disorder; (6) night shift work; or
(7) those already using CBT or were planning to start CBT. Sleep
disorders such as sleep apnea, periodic limb movements in sleep,
parasomnia and hypersomnia were not specifically screened, but
participants were excluded if they reported having any sleep disor-
ders.
All interested participants who registered to participate were
screened by a trained research assistant to determine eligibility,
and for those eligible, a clinical interview was scheduled for further
screening by the principal investigator (S.Y.W.) using both inclu-
sion and exclusion criteria. We mainly relied on patient self-re-
ported information, the additional use of the PHQ and the clinical
interview for determining the eligibility of patients for the study.
The objectives and procedures of the study were also further ex-
plained by obtaining written informed consent.
Randomisation Allocation, Concealment and Blinding
A simple randomisation method was used. For each participant
recruited, the chance of randomising to MBCT-I and PEEC was
Mindfulness for Chronic Insomnia RCT
50/50. After the interview with the principal investigator, partici-
pants were randomly assigned to one of the treatment groups by
using a list of computer-generated random numbers with partici-
pants ranked in the top half of the list being assigned to the inter-
vention group and the rest to the control group. The generation of
random numbers and assignment was performed by a statistician
who was not part of the research team, and the randomisation re-
sults were not announced until participants were enrolled in the
study to ensure concealment of randomisation. The research as-
sistant for data analysis was blinded in respect of the group alloca-
tion results and participants were blinded regarding the study hy-
potheses, that is, participants were only notified of the 2 study
groups – the MBCT-I and PEEC, and there was evidence showing
that both groups might help with insomnia symptoms and they
were not aware of each intervention being hypothesised as being
better. The questionnaires were completed by the participants
themselves. Therefore, the research assistants for data collection in
this study were not blinded concerning the group allocation, and
they assisted in checking the questionnaires and contacting par-
ticipants in case there were some missed items on the question-
naires.
Intervention and Control
Intervention: MBCT-I
After an initial orientation session, the MBCT-I programme
was delivered by qualified instructors with more than 2 years of
teaching experience of MBCT. The MBCT-I treatment protocol
followed the original manual devised by Segal et al. [41], but its
cognitive elements (e.g., giving information) were modified by in-
vestigators (Y.L., C.S.L., and C.C.L.) who were clinical psycholo-
gists and experienced mindfulness teachers to tailor this to patients
with primary insomnia rather than a depressive disorder with both
mindfulness components and components under CBT-I. The
MBCT-I training consisted of weekly 2.5-h sessions over an 8-week
period (20 h in total) with up to 15 participants in each group.
There was no retreat during the 8-week period. Key themes of
MBCT-I included empowerment of participants and a focus on
awareness and acceptance of experience with information and
practices of mindful eating (raisin exercise), body scan, pleasant
events calendar, sitting meditation, “seeing” or “hearing” exercise,
3-min breathing space, mindful stretching, mindful walking and a
calendar of unpleasant events. Both behavioural and cognitive
components were included under the framework of MBCT. Cog-
nitive components included psycho-education about the nature of
sleep and insomnia, as well as interventions towards worries/dys-
functional beliefs towards sleep. However, as opposed to CBT-I,
the intention of MBCT-I was not to change or challenge the rumi-
native thoughts or “dysfunctional” thoughts which have been sug-
gested to cause and sustain insomnia, rather, the aim was to allow
the participants to discover that these thoughts were not facts, and
to form a different relationship with these thoughts. Participants
were guided to develop a “decentred” perspective towards thoughts
and feelings, in which these were viewed as passing events in the
mind. Behavioural components included sleep restriction and
stimulus control besides sleep hygiene. Sleep restriction aimed to
restrict the time in bed to the actual amount of sleep and shaping
a sleep window (the sleep and wake time), according to circadian
rhythms. Participants were introduced to the importance of a reg-
ular rising time, reducing the time allotted for sleep, and determin-
ing the earliest allowable bedtime and maximum allowable time
165.123.34.86 - 7/3/2017 5:07:05 PM
Psychother Psychosom 2017;86:241–253 243
University of Pennsylvania
DOI: 10.1159/000470847
Downloaded by:
allotted for sleep, the time in bed was progressively increased (by
15–30 min) as sleep efficiency improved (when exceeding 85%)
and vice versa, and the sleep window suggested was never fewer
than 5 h per night. Stimulus control strategies aimed to strengthen
the association between the bed/bedroom and sleep. General
guidelines included: (a) to go to bed only when sleepy; (b) to get
out of bed and leave the bedroom when unable to fall asleep or go
back to sleep within 15–20 min, and return to bed only when
sleepy; (c) not to use the bed/bedroom for activities (e.g., watch
television, listen to the radio, eat, or read in the bed) other than
sleep and sexual activities; (d) to get up at the same time every
morning; (e) not to nap during the day; and (f) not to compensate
for lost sleep during holidays. In addition, participants were rec-
ommended to establish a pre-sleep routine every night and wind
down with relaxing activities at least an hour before going to bed.
Sleep hygiene aimed to increase awareness of the impact of lifestyle
and environmental factors on sleep quality and to promote better
sleep hygiene practices through the introduction of the informa-
tion of limiting the use of alcohol and caffeine, increasing exposure
to bright light, creating a sleep environment that is dark, cool and
quiet, exercising or starting to exercise regularly later in the day but
3–6 h before bedtime. The information of sleep restriction and
stimulus control was discussed during sessions, and participants
could modify these behaviours accordingly. However, no home-
work related to these was given. All the homework was related to
daily mindfulness practices, for example, body scan, mindful
breathing, sitting meditation, 3-min breathing space and mindful
stretching, with guided (taped) or unguided awareness exercises
directed at increasing moment by moment nonjudgmental aware-
ness of bodily sensations, thought and feelings together with exer-
cises designed to integrate application of awareness skills into dai-
ly life. In general, about 80% of the in-session time was for mind-
fulness or mindfulness exercises based on the MBCT protocol and
20% was for information on CBT-I components.
Modality: 8 weekly sessions, 2.5 h for each session.
Number of participants in each group: 10–15 participants.
Treatment components: mindfulness information practices;
cognitive components under CBT-I and MBCT-I; educational in-
formation adopted from sleep restriction, stimulus control and
sleep hygiene under CBT-I.
Homework: daily mindfulness practices.
Control: PEEC
After an orientation session, participants in the PEEC group
also received weekly 2.5-h sessions over 8 weeks to match the time
of MBCT-I. The PEEC included psycho-education intervention
with stretching exercises based on principles used in stimulus con-
trol and sleep hygiene education, which had previously been used
as the control group in sleep-related research [42, 43]. Participants
were instructed to follow information about stimulus control and
sleep hygiene similar to the information used in the MBCT-I group.
The information of stimulus control mainly included: (1) to go to
bed only when sleepy at night; (2) to use the bed and bedroom only
for sleep; (3) to get out of bed and go to another room or space when
they are unable to fall asleep and to return to bed only when they
feel sleepy again; and (4) to arise at the same time in the morning
daily [42]. For the other educational component, information on
the effects of caffeine, alcohol and exercise on sleep, and the effects
of surrounding environment such as light, noise and excessive tem-
perature was given to participants [44]. These sessions were admin-
244 Psychother Psychosom 2017;86:241–253
DOI: 10.1159/000470847
istered by registered physiotherapists with at least 2 years of clinical
experience using a treatment manual. The instructors were in-
structed not to use any meditation or cognitive techniques. There
was a 1-h exercise in each class which consisted of mild to moderate
levels of stretching and muscle strengthening exercises with the aim
of inducing fatigue among participants to improve their sleep. Sim-
ilar to the MBCT-I group, the education information was given
during the sessions but no homework was given except for the 1-h
stretching exercises each day.
Modality: 8 weekly sessions, 2.5 h for each session.
Number of participants in each group: 10–15 participants.
Treatment components: educational information adopted
from sleep hygiene, stimulus control; stretching exercise.
Homework: daily mild to moderate levels of stretching and
muscle strengthening exercises.
Participants in both the MBCT-I and PEEC groups were al-
lowed unrestricted access to care for their medical problems (usu-
al care), although they were told not to start any new psychological
treatment or medical treatment for insomnia during the study pe-
riod. To provide a control for the therapist’s attention effect on the
outcome, 3 instructors for MBCT-I and 3 instructors for PEEC
were employed. The 2 groups of instructors had similar levels of
experience to increase the generalisability of findings to show that
it is not the therapist per se but the therapeutic modality that ac-
counts for changes in outcomes. The fidelity of the intervention
and control was ensured and monitored by a random review of one
fourth of the total sessions. With the use of 2 simple checklists –
one was modified based on the Mindfulness-Based Cognitive
Therapy Adherence Scale [45], the other was made based on the
course content of PEEC, the fidelity check was conducted by an
experienced mindfulness instructor and an experienced physio-
therapist independently. Treatment fidelity ratings were 90% for
the MBCT-I group (96.7, 86.7, 93.3% for the 3 instructors, respec-
tively) and 100% for the PEEC group, respectively.
Measurements
Measurements at baseline included the participants’ demo-
graphic data such as age, sex, marital status, education status, month-
ly household income, religious beliefs, use of medication (including
psychotropic drugs and traditional Chinese medicine for sleep im-
provement) and all other outcome measures described below. The
questionnaires were completed by participants independently and
posted back to us or returned in person. Reminders for returning the
questionnaires, with at least 3 telephone calls, and a check for survey
completion were conducted by the research assistant.
Primary Outcome
The primary outcome was insomnia severity, measured by the
total score of the ISI at the 6-month follow-up after the 8-week in-
tervention. The ISI is a 7-item patient reported outcome measure-
ment assessing the severity of initial, middle and late insomnia;
distress about sleep difficulties; interference of insomnia with day-
time functioning and notice of sleep problems by others. It has
good psychometric properties and is sensitive in measuring re-
sponses in treatment trials [46]. The Chinese version has been val-
idated with good psychometric properties [47].
Secondary Outcomes
The secondary outcome measures included SOL, wake time af-
ter sleep onset (WASO), TST and sleep efficiency (ratio of sleep
time to the time spent in bed), which were collected using a sleep
165.123.34.86 - 7/3/2017 5:07:05 PM
Wong/Zhang/Li/Yip/Chan/Ling/Lo/Woo/
University of Pennsylvania
Sun/Ma/Mak/Gao/Lee/Wing
Downloaded by:
 Assessed for eligibility (n = 1,154)

Enrollment Excluded (n = 938)

• Not meeting inclusion criteria (n = 790)
• Refused to participate (n = 148)

Randomised (n = 216)

Allocation
Allocated to mindfulness-based cognitive therapy
for insomnia (MBCT-I) (n = 111)
• Received allocated intervention (n = 101)
• Did not receive allocated intervention (n = 10)
– Time restriction (n = 3), unable to content (n = 3),
declined (n = 2), sickness (n = 2)
Allocated to psycho-education with stretching
exercise control (PEEC) for insomnia (n = 105)
• Received allocated intervention (n = 95)
• Did not receive allocated intervention (n = 10)
– Time restriction (n = 2), unable to content (n = 4),
declined (n = 3), sickness (n = 1)

Follow-up
Lost to follow-up (n = 18) Lost to follow-up (n = 23)
– Declined to continue (n = 8) – Declined to continue (n = 13)
– Did not return questionnaire (n = 10) – Did not return questionnaire (n = 10)

Analysis
Analysed (n = 101) Analysed (n = 95)
– Excluded from analysis (n = 10) (absent from all – Excluded from analysis (n = 10) (absent from all
intervention courses and no follow-ups) education courses and no follow-ups)

Fig. 1. The Consolidated Standards of Reporting Trials flow diagram of the study.

diary. The sleep diary is a standard instrument for assessing sleep
outcomes in insomnia research [26]. Participants were required to
keep daily sleep dairies during a 2-week baseline period, during the
8-week acute treatment and for 2 weeks prior to the follow-up as-
sessments at 5 and 8 months, respectively. Mindfulness was mea-
sured by the Five Facet Mindfulness Questionnaire, with higher
scores indicating a higher mindfulness level [48]. This scale has
been recently translated in Hong Kong and has undergone initial
validation process [48]. Furthermore, health service utilisation in-
formation was collected, which included visits to primary care and
secondary care doctors (both private and public), Accident and
Emergency, hospitalisations and the number of days absent from
work attributable to insomnia or other illnesses in the preceding
month at each time point.
Other measures included the frequency and duration of prac-
tice of meditation in the MBCT-I group, which was recorded by
participants for two weeks at 2, 5, and 8 months. Compliance with
the PEEC exercises was also collected at similar time points. More-
over, medication use including changes in medication was moni-
tored at baseline, 2, 5 and 8 months. Response rate (enrollment of
subjects) and retention rate (number and proportion that attended
each class) of participants of each of the intervention were docu-
mented.
Sample Size
The target sample size was 214. A previous study [37] found an
effect size of MBI for ISI at 8 weeks of 0.76 and at 5 months of 0.80
when compared to treatment with eszopiclone. We conservatively
assume an effect size of 0.50 for the ISI score and a sample size of
85 participants per treatment group was needed during the 8-week
intervention with a 2-sided type I error of 5 and 90% power to de-
tect the proposed effect size. To compensate for a dropout rate of
20%, we set our enrollment target at 214 subjects.
Data Analysis
Baseline characteristics of the two groups were compared using
independent samples t test for continuous variables and χ2 test for
categorical variables. For primary analyses, the ISI total score was
the dependent variable, and group and time and their interaction
term served as the predictors in the linear mixed model. For sec-
ondary analyses, outcome variables that included SOL, WASO,
TST or sleep efficiency measured by the sleep diary and mindful-
ness level measured by the FFMQ total score were entered as de-
pendent variables into the linear mixed models. Dependent vari-
able with an unstructured covariance pattern and fixed effect pa-
rameters were applied. The missing data were left as missing, no
imputation method was employed, except for 5–6 subjects at each
time point, who returned the questionnaire but missed 1 or 2 items
among 7 items of the ISI and their ISI score was multiplied by 7/6
165.123.34.86 - 7/3/2017 5:07:05 PM

Mindfulness for Chronic Insomnia RCT Psychother Psychosom 2017;86:241–253 245

University of Pennsylvania

DOI: 10.1159/000470847
Downloaded by:
 Table 1. Baseline information of participants with primary chronic insomnia

Items MBCT-I (n = 111) PEEC (n = 105) p value

Age at enrollment, years, mean (SD) 55.6 (9.1) 56.6 (9.7) 0.450
Female, n (%) 91 (82.0) 78 (74.3) 0.171
Education, n (%)a 0.863
Primary school or below 22 (20.0) 18 (17.1)
Secondary school 49 (44.5) 48 (45.7)
Diploma or above 39 (35.5) 39 (37.1)
Occupation, n (%)b 0.576
Housewife 33 (30.6) 33 (32.7)
Employed 39 (36.1) 41 (40.6)
Retired or unemployed 36 (33.3) 27 (26.7)
Marital status, n (%)a 0.728
Single 19 (17.1) 14 (13.5)
Married 82 (73.9) 79 (76.0)
Live alone/separated/divorced/widowed 10 (9.0) 11 (10.6)
Religion, n (%)c 50 (49.5) 38 (40.9) 0.227
Monthly household income, n (%)b 0.474
HKD 10,000 or below 26 (23.9) 29 (29.0)
HKD 10,001 – 20,000 24 (22.0) 20 (20.0)
HKD 20,001 – 30,000 33 (30.3) 22 (22.0)
HKD 30,001 or above 26 (23.9) 29 (29.0)

MBCT-I, mindfulness-based cognitive therapy for insomnia; PEEC, psycho-education with stretching exer-
cise control. a Missing, n = 1; percentage of those with available data. b Missing, n = 7; percentage of those with
available data. c Missing, n = 22; percentage of those with available data.

or 7/5, in to account for subjects with one or several missing items
in FFMQ at each time point. For the 20 participants who had no
baseline data, their data of the ISI and sleep diary during screening
was used. A normality test of dependent variables was conducted
and they were normally distributed, and we used Akaike’s Infor-
mation Criteria to select the best-fit of covariance pattern. Assum-
ing the missing data were missing at random, linear mixed model
uses all non-missing data (i.e., no list-wise deletion) and has com-
parable results with other approaches, such as multiple imputation
[49]. Results from logistic regression (1 = any missing of the pri-
mary outcome, 0 = no missing) confirmed that the missing data,
comparing the two groups, were balanced and no significant dif-
ference was found even adjusting for age, sex and baseline ISI
score. χ2 tests and two-sample t tests were used for comparing re-
sults of health service utilisation in the last month for the MBCT-I
and PEEC groups. In addition, clinical remission rates (ISI score
of less than 8) and treatment response rates (ISI score of more than
7 points reduction from baseline) were compared for the two
groups at each time point using logistic regressions [34, 50]. Anal-
ysis of variance was conducted to test the differences within differ-
ent instructors in the MBCT-I group or the PEEC group at differ-
ent time points. The between group effect sizes (Cohen’s d) were
calculated using the mean differences from baseline and the SDs
of the two groups at each time point. The within group Cohen’s d
was calculated with the means and their standard errors at each
time point of each of the two groups separately, using the method
by Nakagawa and Cuthill [51]. Analyses were performed on an
intention-to-treat basis. For participants who did not return base-
line questionnaire, their results of ISI and sleep diary during
screening were used in the analysis. Per-protocol analysis was con-
ducted in terms of course attendance (attending at least 6 out of 8
classes) and compliance of practice (practicing at least 3 times per
week). SPSS 20 (SPSS Inc, Chicago, IL, USA) was used for data
analysis. The statistically significant level was p < 0.05 (2 sides).
Results
Participants were recruited from July 2012 to January
2014. Out of the 1,154 screened participants, 790 were
excluded since they were ineligible for the study. There
were 216 (59.3%) who were successfully recruited out of
the 364 eligible participants (Fig. 1; Table 1). Most par-
ticipants in this study were females, married and with an
educational level at or above secondary school. The char-
acteristics of the MBCT-I group (n = 111) and PEEC
group (n = 105) were balanced at baseline. There were
73.3% (n = 74) and 81.1% (n = 77) of the participants in
the MBCT-I and PEEC groups who attended at least 6 out
of the 8 sessions, respectively.
165.123.34.86 - 7/3/2017 5:07:05 PM

246 Psychother Psychosom 2017;86:241–253 Wong/Zhang/Li/Yip/Chan/Ling/Lo/Woo/

University of Pennsylvania

DOI: 10.1159/000470847 Sun/Ma/Mak/Gao/Lee/Wing

Downloaded by:
Table 2. Results of primary and secondary outcomes using linear mixed models

Mean (SD) Mean change from Effect size within group Between-group p value of
baseline (SD) effect size interaction
terma
MBCT-I PEEC MBCT-I PEEC MBCT-I PEEC

ISI
Baseline 18.2 (3.8) 17.7 (3.6)
2 months 14.1 (4.0) 14.9 (4.7) – 4.0 (3.7) – 2.7 (3.9) –1.062 –0.613 –0.360 0.023c
(–1.335, –0.789) (–0.829, –0.396) (–0.675, –0.046)
5 months 13.5 (4.4) 13.7 (4.7) – 4.4 (4.0) – 3.7 (4.3) –1.090 –0.857 –0.179 0.344
(–1.391, –0.789) (–1.130, –0.585) (–0.515, 0.156)
8 months 12.8 (4.9) 12.9 (5.2) – 5.2 (4.1) – 4.4 (5.4) –1.172 –0.964 –0.161 0.405
(–1.473, –0.871) (–1.281, –0.648) (–0.501, 0.180)
FFMQ
Baseline 114.8 (12.0) 121.6 (11.5)
2 months 118.8 (11.8) 124.0 (9.6) 2.5 (10.0) 2.4 (7.6) 0.213 0.220 0.008 0.725
(0.017, 0.409) (0.065, 0.375) (–0.306, 0.321)
5 months 116.4 (11.5) 121.9 (10.0) 0.6 (10.3) 0.6 (9.2) 0.054 0.052 0.006 0.728
(–0.157, 0.266) (–0.149, 0.252) (–0.330, 0.342)
8 months 119.6 (12.9) 121.4 (10.3) 3.4 (12.5) 0.2 (8.6) 0.272 0.022 0.295 0.051
(0.019, 0.525) (–0.166, 0.210) (–0.051, 0.640)
SOL (min)
Baseline 67.6 (40.1) 58.6 (42.4)
2 months 48.6 (30.7) 52.4 (53.5) –17.6 (23.2) –18.3 (34.8) –0.499 –0.438 0.024 0.315
(–0.702, –0.296) (–0.675, –0.201) (–0.361, 0.408)
5 months 46.4 (31.8) 39.9 (29.8) –18.5 (28.1) –25.0 (33.7) –0.559 –0.619 0.211 0.833
(–0.807, –0.311) (–0.889, –0.349) (–0.182, 0.605)
8 months 47.9 (27.5) 44.3 (31.7) –24.0 (36.2) –18.2 (32.8) –0.710 –0.485 –0.168 0.313
(–1.081, –0.338) (–0.788, –0.182) (–0.625, 0.288)
WASO (min)
Baseline 89.0 (68.1) 83.8 (68.5)
2 months 57.7 (52.6) 67.7 (68.5) –32.5 (56.2) – 7.0 (46.3) –0.469 –0.108 –0.499 0.049 c
(–0.711, –0.226) (–0.300, 0.084) (–0.893, –0.105)
5 months 57.6 (54.8) 65.1 (51.0) –30.0 (58.4) – 8.6 (38.0) –0.467 –0.167 –0.430 0.033c
(–0.730, –0.203) (–0.381, 0.047) (–0.832, –0.027)
8 months 53.0 (46.8) 54.6 (46.1) –20.7 (38.2) –24.9 (47.8) –0.398 –0.448 0.098 0.244
(–0.649, –0.147) (–0.748, –0.148) (–0.365, 0.560)
TST (min)
Baseline 300.3 (85.4) 300.1 (80.5)
2 months 318.4 (66.2) 317.1 (76.6) 32.1 (49.0) 23.9 (64.2) 0.465 0.290 0.142 0.949
(0.250, 0.680) (0.075, 0.505) (–0.245, 0.529)
5 months 316.0 (70.6) 332.8 (75.7) 26.6 (67.2) 44.8 (68.0) 0.337 0.559 –0.269 0.203
(0.099, 0.576) (0.288, 0.830) (–0.669, 0.130)
8 months 339.2 (82.6) 335.3 (69.3) 42.6 (53.5) 57.0 (52.4) 0.528 0.816 –0.272 0.705
(0.286, 0.771) (0.517, 1.114) (–0.727, 0.183)
Sleep efficiencyb
Baseline 63.0 (16.8) 64.4 (17.4)
2 months 68.5 (14.1) 68.4 (16.3) 7.7 (10.0) 6.0 (13.4) 0.510 0.357 0.139 0.630
(0.301, 0.718) (0.135, 0.580) (–0.248, 0.526)
5 months 67.7 (14.8) 71.1 (16.1) 6.8 (12.4) 9.4 (14.0) 0.438 0.553 –0.198 0.406
(0.207, 0.668) (0.288, 0.817) (–0.597, 0.201)
8 months 71.0 (16.1) 71.3 (13.8) 9.0 (11.4) 10.8 (11.8) 0.577 0.742 –0.162 0.878
(0.309, 0.845) (0.437, 1.046) (–0.615, 0.292)

MBCT-I, mindfulness-based cognitive therapy for insomnia; PEEC, psycho-education with stretching exercise control; ISI, the Insomnia Severity Index;
FFMQ, the Five Facet Mindfulness Questionnaire; SOL, sleep onset latency; WASO, wake time after sleep onset; TST, total sleep time. a Results at baseline
as referent. b The PEEC group as the reference group. c Interaction of group and time. Significant p values are in bold.
165.123.34.86 - 7/3/2017 5:07:05 PM

Mindfulness for Chronic Insomnia RCT Psychother Psychosom 2017;86:241–253 247

University of Pennsylvania

DOI: 10.1159/000470847
Downloaded by:
 Twenty participants (9.3%) were absent from all cours-
es and had no follow-ups after the orientation session.
They were treated as drop-outs and not included in the
analyses. Compared to the remaining 196 participants,
these 20 participants had a lower educational level (p =
0.027) but no statistical differences were seen in other
baseline characteristics. After excluding these 20 partici-
pants, there were no statistically significant differences in
baseline characteristics between the MBCT-I (n = 101)
and the PEEC groups (n = 95).
Primary Outcome
Group and time interaction effect was seen only at 2
months, which indicated better improvement of the ISI
total score in the MBCT-I group at 2 months (p = 0.023,
effect size = 0.360) but it was not seen at 5 and 8 months
(Table 2; online suppl. Fig. 1; for all online sup. material,
see www.karger.com/doi/10.1159/000470847). Addi-
tionally, the time effects were statistically significant and
suggested that the ISI total scores decreased at each time
point for both groups over the 8 months (estimate [95%
CI] –4.38 [–5.44, –3.31], p < 0.001 at 8 months).
Online supplementary Figure 2 shows the remission
rates and treatment response rates of the two groups
based on the ISI cut-off scores at each time point. Com-
pared with the PEEC group, the ORs of treatment re-
sponse for the MBCT-I group were 2.02 (95% CI 0.80–
5.13), 1.31 (0.52–3.26) and 1.65 (0.75–3.65) at 2, 5 and
8 months, respectively and the ORs of remission were
0.78 (0.17–3.60), 0.68 (0.18–2.51) and 0.88 (0.35–2.20)
at 2, 5, and 8 months, respectively. No significant dif-
ferences were found between the MBCT-I and PEEC
groups.
Secondary Outcomes
No group and time interaction effect was seen in terms
of any secondary outcomes (SOL, WASO, TST, sleep ef-
ficiency) measured by the sleep diary at any time points
(p > 0.05), except for WASO at 2 and 5 months with the
MBCT-I group having less WASO compared with the
PEEC group (p = 0.049 and p = 0.033). No group and
time interaction effect was seen in the mindfulness level
measured by the FFMQ at 2, 5 and 8 months (Table 2;
online suppl. Fig. 2). Additionally, time effects were seen
in TST, SOL and sleep efficiency, but not WASO and
FFMQ at every time point which suggested that both
groups had improved in terms of TST, SOL and sleep ef-
ficiency over the 8 months. At 8 months, the estimate was
45.51 min for TST (95% CI 28.60–62.43, p < 0.001),
–18.27 min for SOL (95% CI –27.32, –9.21, p < 0.001) and
248 Psychother Psychosom 2017;86:241–253
DOI: 10.1159/000470847
8.6% for sleep efficiency (95% CI 5.19–12.06, p < 0.001),
and WASO only showed decrease in both groups at
8 months (estimate [95% CI] –20.68 [–33.60, –7.76] min,
p = 0.002).
At baseline, 9 (8.1%) participants in the MBCT-I
group and 5 (4.8%) in the PEEC group had been absent
from work during the previous month. Throughout the
follow-up period, 12 (10.8%) and 9 (8.6%) participants in
MBCT-I and PEEC groups, respectively, reported an ab-
sence from work. No statistically significant differences
were seen in the days of absence from work, as well as
health service utilisation, between the MBCT-I and PEEC
groups at 8 months (online suppl. Table 1). At baseline,
10 (9.0%) participants from the MBCT-I group and 4
(3.8%) from the PEEC group reported medication use for
insomnia. During follow-ups, 7 (6.3%) and 2 (1.9%) par-
ticipants in the MBCT and PEEC groups, respectively,
stopped taking their medication for insomnia, while 5
(4.5%) and 4 (3.8%) newly reported taking medication
for insomnia.
Among those who practised, the mean (SD) of total
mindfulness practice time per week was 280.0 (152.4)
min (n = 39 participants practised out of 45 participants
who returned practice records, 86.7%), 290.9 (183.0) min
(n = 35 out of 46 participants, 76.1%) and 314.6 (164.3)
min (n = 28 out of 36 participants, 77.8%) at 2, 5, and 8
months, respectively, in the MBCT-I group. The mean
(SD) of total exercise practice time per week was 231.6
(161.0) min (n = 51 out of 57 participants who returned
practice records, 89.5%), 178.6 (104.0) (n = 40 out of 50
participants, 80%) and 183.1 (117.4) min (n = 32 out of
45 participants, 71.1%) at 2, 5, and 8 months, respective-
ly, among those who performed exercises in the PEEC
group.
No differences were seen in any primary or secondary
outcomes among the different instructors within either
group. The primary and secondary results were similar to
the above results after using per protocol samples includ-
ing only participants who attended at least 6 out of the 8
sessions (n = 151) or who had practised at least 3 times
per week at any follow-up assessment (n = 96), that is,
42.6% (n = 43) in the MBCT-I group and 55.8% (n = 53)
in the PEEC group.
Adverse Events
No adverse events were reported by participants in ei-
ther group.
165.123.34.86 - 7/3/2017 5:07:05 PM
Wong/Zhang/Li/Yip/Chan/Ling/Lo/Woo/
University of Pennsylvania
Sun/Ma/Mak/Gao/Lee/Wing
Downloaded by:
 Discussion
This is one of the few studies with a relatively large
sample of participants to evaluate the efficacy of MBCT-I
in improving sleep-related parameters among people
with chronic primary insomnia when compared with an
active control group with psycho-education and relax-
ation exercise. Beneficial effects on the reduction of in-
somnia severity were not observed in MBCT-I over the
longer term when compared with PEEC, although short-
er-term benefits with a small effect size were seen at post-
intervention. Both groups showed improvements in in-
somnia severity measured by the ISI as well as SOL, TST,
WASO and sleep efficiency measured by the sleep diary,
however, no group differences were seen in these sleep
parameters at 8 months. No significant change was seen
in health service utilisation and absence from work in ei-
ther group at 8 months. The treatment response rate and
remission rate were also not significantly different be-
tween the MBCT-I and PEEC groups at any time point
though the study was not designed to detect the binary
difference of response and remission rates based on the
ISI cut-off scores between the two groups (post-hoc pow-
er was around 0.3). With per protocol analyses, the results
remained unchanged.
It is difficult to tell whether the lack of superiority be-
yond 8 weeks was due to the lack of sustained effects of
MBCT-I or due to the lack of continued practice. It is also
difficult to decide which components were responsible
for the effects over a shorter time as the intervention was
regarded as a whole. It is suggested that each therapeutic
act could be a result of multiple specific or non-specific
ingredients, for example, the treatment components, or
the participant-therapist interaction and peer support
[52]. The FFMQ scores had not significantly improved in
the MBCT-I group at 8 months or post-intervention, sug-
gesting that the FFMQ score might not be directly related
to the change of insomnia severity level that was better
only at post-intervention. It was also not clear why par-
ticipants stopped or continued practices as we had not
collected information about the reasons. Homework re-
lated to CBT components, besides mindfulness practices,
as well as booster sessions or regular reunions might be
needed to motivate health behaviour and practices at fol-
low-ups in the intervention design.
A recent systematic review and meta-analysis [11], in-
cluding 20 studies on CBT-I for chronic insomnia, found
that compared to inactive controls (waitlist, care as usual,
sleep hygiene or placebo tablets), CBT-I group had its
“SOL improved by 19.03 (95% CI 14.12–23.93) min, wake
Mindfulness for Chronic Insomnia RCT
after sleep onset improved by 26.00 (95% CI 15.48–36.52)
min, TST improved by 7.61 (95% CI –0.51, 15.74) min
and sleep efficiency improved by 9.91% (95% CI 8.09–
11.73) at the post-treatment time point,” and “changes
seemed to be sustained at later time points.” Another re-
cent meta-analysis [14] found that group CBT-I, com-
pared to inactive controls, had a medium to large effect
size for SOL, sleep efficiency and wake after sleep onset
and small effect sizes for pain outcomes and effect sizes
remained significant at follow-up, suggesting that treat-
ment gains persist over time. However, we did not see
sustained group effects in the long term compared to an
active control though time effects were found with im-
provements seen in sleep quality in both groups, and the
improvements seemed within the improvement range
showed in the review on CBT-I above [11]. One thing that
needs to be noted is that we had used a relatively effective
active control including both psycho-education (includ-
ing information of sleep hygiene and stimulus control)
and stretching exercises. Our within group effect sizes
were comparable to CBT-I when CBT-I was compared to
inactive control [11, 14]. Exercises were found to be effec-
tive for chronic insomnia as shown in trials and a system-
atic review [53–55]. Previous studies suggested that sleep
restriction and stimulus control are effective components
for ameliorating insomnia [11], and sleep hygiene may be
seen as a minimum intervention and alone it has little ef-
fect [15]. Furthermore, our intervention protocol did not
include homework for CBT-I components (e.g., sleep re-
striction or stimulus control), but only homework for
mindfulness practices or stretching exercises. It is again
hard to decide which components worked or not, though
the within group effects of MBCT-I might be the results
of CBT-I components instead of mindfulness in the study.
Our MBCT-I was adapted from the original MBCT for
depression by replacing the information for depression
with the information for insomnia with CBT-I compo-
nents. It cannot be regarded as a combination of mindful-
ness and full CBT-I. Additionally, the insomnia severity
levels seemed to be a little higher in our sample compared
to subjects with chronic insomnia in other studies [11,
14]. We did not compare MBCT-I with CBT-I or seda-
tives in current study head-to-head. Caution should be
exercised when comparing results in the current trial with
results in the two meta-analyses on CBT-I directly due to
differences in study design and setting [11, 14]. A recent
trial on the treatment of insomnia comorbid with cancer
[56] showed that MBSR is similar to CBT-I in producing
clinically significant improvements. However, when our
trial is compared to another study that compared the ef-
165.123.34.86 - 7/3/2017 5:07:05 PM
Psychother Psychosom 2017;86:241–253 249
University of Pennsylvania
DOI: 10.1159/000470847
Downloaded by:
fects of 6-week CBT with 6-week CBT plus zolpidem
for 160 adults with persistent insomnia [57], the treat-
ment response rate (29.2%) and remission rate (15.4%) at
8 months in our study were lower than the rates also mea-
sured by the ISI cut-off scores in their two intervention
groups during the study period and at 6-month follow-up
(treatment response rates were around 60% and treat-
ment remission rates were around 40%) [57], though we
should also be cautious about making direct comparisons
as the study population and interventional protocols are
not exactly the same.
Previous studies with small sample sizes that evaluated
MBIs among people with chronic insomnia demonstrated
an improvement in sleep outcomes [34–37]. Two [34, 36]
of these studies to compare the sleep quality change mea-
sured by the ISI in MBI group with health education group
[36] or self-monitoring [34] at post-intervention showed
a large effect size favouring the MBI group. In our current
study, we observed a small reduction in insomnia severity
at immediate post-intervention with a small effect size and
not at other time points. Besides the differences in sample
size and the age of study population, the specific interven-
tion components in our MBCT-I might be different from
those of previous studies (e.g., MBSR was used in the study
by Gross et al. [37] or Zhang et al. [35], MBSR or mindful-
ness-based therapy for insomnia (MBTI) by Ong et al. [34]
or a 6-week mindful awareness practices intervention by
Black et al. [36]). In principle, the MBTI used by Ong et
al. [34] was most similar to the MBCT-I components used
in our current study. Ong et al. [34] MBTI included spe-
cific behavioural strategies for insomnia such as stimulus
control, sleep restriction and sleep hygiene under princi-
ples in the original MBCT protocol by Segal et al. [41],
although no cognitive components were described and all
interventions were delivered by the author while in our
study, 3 clinical psychologists with training in both CBT
and MBCT delivered the MBCT-I intervention. Another
difference was that no one day retreat was included in our
MBCT-I protocol. As a result, it is not certain whether the
therapist’s effects or the addition of a 1-day retreat played
a role in the improvements in Ong et al. [34] study (effect
sizes were 1.33 and 2.07 for MBSR and MBTI, respective-
ly, at post-intervention, while they were 1.062 for MBCT-
I and 0.613 for PEEC in our current study) or that other
unmeasured characteristics were responsible for superior
outcomes among the MBTI group in Ong et al. [34] study.
Furthermore, their comparison group was an 8-week self-
monitoring condition.
The strength of this study is that this is the first study
using MBCT-I among Chinese chronic primary insom-
250 Psychother Psychosom 2017;86:241–253
DOI: 10.1159/000470847
nia patients with a relatively large sample size and long
follow-up period. Furthermore, the interventions were
conducted with standard protocols by trained and expe-
rienced instructors with no inter-instructor differences
being seen, which suggests a high generalisability of inter-
ventions.
The study has several limitations. First, we did not in-
clude a usual care control or control with no attention,
though current evidence suggests that chronic insomnia
is a relatively stable condition which is unlikely to be im-
proved naturalistically [15, 58, 59]. And we did not com-
pare it with CBT-I or sedatives or both. Second, as men-
tioned earlier, the practice of mindfulness or stretching
exercises by participants in the MBCT-I and PEEC groups
was low after the completion of the 8-week course. Future
intervention study can investigate the reasons for non-
compliance of practice and may consider adding regular
follow-up booster sessions to increase participants’ prac-
tice. Third, it is hard to decide which components in the
two groups were responsible for the effects as both groups
had multiple specific and non-specific components, and
we did not include CBT-I related homework except for
the mindfulness practices or exercises. There were com-
mon components between the two interventions in this
study. These included both educational components on
sleep hygiene and stimulus control, while there were dif-
ferences in other specific components. These included
mindfulness and cognitive component as well as educa-
tional component on sleep restriction in the MBCT-I
group while for the PEEC group, there was stretching ex-
ercise. One meta-analytical review by Kredlow et al. [60]
found that regular exercise had small-to-medium benefi-
cial effects on SOL, and small beneficial effects on sleep
efficiency and TST. For sleep restriction, a systematic re-
view by Miller et al. [61] showed that it had moderate-to-
large beneficial effects on SOL, sleep efficiency and
WASO, and a small effect on TST. The cognitive therapy
alone also improved the sleep quality in an open trial by
Harvey et al. [62]. Although MBCT-I was superior to
PEEC at post-intervention, this might be explained by the
additional benefits of CBT-I components (sleep restric-
tion and cognitive components) instead of mindfulness,
as the FFMQ score did not improve at post-intervention.
Furthermore, there was no difference in outcomes be-
tween MBCT-I and PEEC in the long term. Fourth, we
did not specifically conduct the Structured Clinical Inter-
view for DSM Disorders/Composite International Diag-
nostic Interview or screen for sleep disorders but mainly
relied on patient self-report of mental and physical dis-
eases to decide eligibility although clinical interviews
165.123.34.86 - 7/3/2017 5:07:05 PM
Wong/Zhang/Li/Yip/Chan/Ling/Lo/Woo/
University of Pennsylvania
Sun/Ma/Mak/Gao/Lee/Wing
Downloaded by:
were conducted and PHQ was used as a supplement for
screening. Future studies shall consider using the above
structured interviews to screen for patients with chronic
primary insomnia. Fifth, although we applied different
strategies in contacting participants during follow-ups,
for example, at least 3 telephone reminders, there were
still participants who were not available for a follow-up.
Moreover, a slightly lower educational level was seen
among participants who dropped out soon after the ori-
entation, which suggests that participants with a higher
educational level may be more receptive to MBCT-I and
PEEC, and this will need further research to delineate fac-
tors associated with acceptability to interventional stud-
ies. Twenty participants did not return the baseline ques-
tionnaire and were “no shows” after agreeing to join the
study and randomisation. Their screening data of the ISI
and sleep diary were included in the data analysis. How-
ever, the results were the same whether we included or
excluded data from these 20 participants. Sixth, recall bias
might exist for the daily recording of sleeping pattern and
behaviour although these were validated measures. Final-
ly, no objective measurements of sleep parameters such
as wrist actigraphy or laboratory polysomnography were
conducted and all our outcomes were based on self-re-
ported scales.
In summary, the results of this trial in general do not
support the superiority of MBCT-I for chronic primary
insomnia patient over PEEC in the long term. We are
conservative in suggesting further use of MBCT-I with
this specific group of patients with chronic primary in-
somnia to improve their sleep quality. In view of the
group size, time needed and effect sizes of CBT-I in previ-
ous studies [14], CBT-I is the first-line non-pharmaco-
logic intervention choice for chronic primary insomnia
[11, 14, 15] until further supporting evidence from an al-
ternative intervention is available.
Acknowledgments
This study was supported by the Health and Medical Research
Fund, Research Fund Secretariat, Food and Health Bureau, The
Government of the Hong Kong Special Administrative Region
(HKSAR; grant reference number: 9100611). We thank the Food
and Health Bureau, HKSAR for its valuable support. We would
also like to thank the following general out-patient clinics (in al-
phabetical order) for providing facilitation in subject recruitment:
Fanling Family Medicine Centre, Lek Yuen General Out-Patient
Clinic, Ma On Shan Family Medicine Centre, Shatin General Out-
Patient Clinic, Shek Wu Hui Jockey Club General Out-Patient
Clinic and Wong Siu Ching Family Medicine Centre.
Disclosure Statement
The authors have no conflicts of interest to declare.

References
1 Morin CM, LeBlanc M, Daley M, Gregoire JP,
Merette C: Epidemiology of insomnia: preva-
lence, self-help treatments, consultations,
and determinants of help-seeking behaviors.
Sleep Med 2006;7:123–130.
2 Zhang J, Li AM, Kong AP, Lai KY, Tang NL,
Wing YK: A community-based study of in-
somnia in Hong Kong Chinese children:
Prevalence, risk factors and familial aggrega-
tion. Sleep Med 2009;10:1040–1046.
3 Zhang J, Lam SP, Li SX, Yu MW, Li AM, Ma
RC, Kong AP, Wing YK: Long-term out-
comes and predictors of chronic insomnia: a
prospective study in Hong Kong Chinese
adults. Sleep Med 2012;13:455–462.
4 National Institutes of Health: National Insti-
tutes of Health State of the Science Confer-
ence statement – manifestations and man-
agement of chronic insomnia in adults, June
13–15, 2005. Sleep 2005;28:1049–1057.
5 Daley M, Morin CM, LeBlanc M, Gregoire JP,
Savard J: The economic burden of insomnia:
Direct and indirect costs for individuals with
insomnia syndrome, insomnia symptoms,
and good sleepers. Sleep 2009;32:55–64.
6 Simon GE, VonKorff M: Prevalence, burden,
and treatment of insomnia in primary care.
Am J Psychiatry 1997;154:1417–1423.
7 Sarsour K, Kalsekar A, Swindle R, Foley K,
Walsh JK: The association between insomnia
severity and healthcare and productivity
costs in a health plan sample. Sleep 2011; 34:
443.
8 Kessler RC, Berglund PA, Coulouvrat C,
Hajak G, Roth T, Shahly V, Shillington AC,
Stephenson JJ, Walsh JK: Insomnia and the
performance of US workers: results from the
America insomnia survey. Sleep 2011; 34:
1161–1171.
9 Shahly V, Berglund PA, Coulouvrat C,
Fitzgerald T, Hajak G, Roth T, Shillington
AC, Stephenson JJ, Walsh JK, Kessler RC:
The associations of insomnia with costly
workplace accidents and errors: results from
the America insomnia survey. Arch Gen Psy-
chiatry 2012;69:1054–1063.
10 Morin CM, Gaulier B, Barry T, Kowatch RA:
Patients’ acceptance of psychological and
pharmacological therapies for insomnia.
Sleep 1992;15:302–305.
11 Trauer JM, Qian MY, Doyle JS, Rajaratnam
SM, Cunnington D: Cognitive behavioral
therapy for chronic insomnia: a systematic
review and meta-analysis. Ann Intern Med
2015;163:191–204.
12 Espie CA, MacMahon KM, Kelly HL, Broom-
field NM, Douglas NJ, Engleman HM, McK-
instry B, Morin CM, Walker A, Wilson P:
Randomized clinical effectiveness trial of
nurse-administered small-group cognitive
behavior therapy for persistent insomnia in
general practice. Sleep 2007;30:574–584.
13 Jansson M, Linton SJ: Cognitive-behavioral
group therapy as an early intervention for in-
somnia: a randomized controlled trial. J Oc-
cup Rehabil 2005;15:177–190.
14 Koffel EA, Koffel JB, Gehrman PR: A meta-
analysis of group cognitive behavioral thera-
py for insomnia. Sleep Med Rev 2015; 19:
6–16.
165.123.34.86 - 7/3/2017 5:07:05 PM

Mindfulness for Chronic Insomnia RCT Psychother Psychosom 2017;86:241–253 251

University of Pennsylvania

DOI: 10.1159/000470847
Downloaded by:
15 Morin CM, Benca R: Chronic insomnia. Lan-
cet 2012;379:1129–1141.
16 Winbush NY, Gross CR, Kreitzer MJ: The ef-
fects of mindfulness-based stress reduction
on sleep disturbance: a systematic review. Ex-
plore (NY) 2007;3:585–591.
17 Kabat-Zinn J: Full Catastrophe Living: Using
the Wisdom of Your Body and Mind to Face
Stress, Pain, and Illness. New York, Dela-
court, 1990.
18 Baer RA: Mindfulness training as a clinical
intervention: a conceptual and empirical re-
view. Clin Psychol Sci Pr 2003;10:125–143.
19 Carlson LE, Speca M, Patel KD, Goodey E:
Mindfulness-based stress reduction in rela-
tion to quality of life, mood, symptoms of
stress, and immune parameters in breast and
prostate cancer outpatients. Psychosom Med
2003;65:571–581.
20 Piet J, Hougaard E: The effect of mindfulness-
based cognitive therapy for prevention of re-
lapse in recurrent major depressive disorder:
a systematic review and meta-analysis. Clin
Psychol Rev 2011;31:1032–1040.
21 Morin CM, Rodrigue S, Ivers H: Role of
stress, arousal, and coping skills in primary
insomnia. Psychosom Med 2003;65:259–267.
22 Kim SM, Park JM, Seo HJ: Effects of mindful-
ness-based stress reduction for adults with
sleep disturbance: a protocol for an update of
a systematic review and meta-analysis. Syst
Rev 2016;5:51.
23 Lengacher CA, Reich RR, Post-White J, Mos-
coso M, Shelton MM, Barta M, Le N, Budhra-
ni P: Mindfulness based stress reduction in
post-treatment breast cancer patients: an ex-
amination of symptoms and symptom clus-
ters. J Behav Med 2012;35:86–94.
24 Johns SA, Brown LF, Beck-Coon K, Monah-
an PO, Tong Y, Kroenke K: Randomized con-
trolled pilot study of mindfulness-based
stress reduction for persistently fatigued can-
cer survivors. Psychooncology 2015; 24: 885–
893.
25 Andersen SR, Wurtzen H, Steding-Jessen M,
Christensen J, Andersen KK, Flyger H,
Mitchelmore C, Johansen C, Dalton S: Effect
of mindfulness-based stress reduction on
sleep quality: results of a randomized trial
among Danish breast cancer patients. Acta
Oncol 2013;52:336–344.
26 Britton WB, Haynes PL, Fridel KW, Bootzin
RR: Polysomnographic and subjective pro-
files of sleep continuity before and after
mindfulness-based cognitive therapy in par-
tially remitted depression. Psychosom Med
2010;72:539–548.
27 Britton WB, Haynes PL, Fridel KW, Bootzin
RR: Mindfulness-based cognitive therapy
improves polysomnographic and subjective
sleep profiles in antidepressant users with
sleep complaints. Psychother Psychosom
2012;81:296–304.
252 Psychother Psychosom 2017;86:241–253
DOI: 10.1159/000470847
28 Gross CR, Kreitzer MJ, Thomas W, Reilly-
Spong M, Cramer-Bornemann M, Nyman
JA, Frazier P, Ibrahim HN: Mindfulness-
based stress reduction for solid organ trans-
plant recipients: a randomized controlled tri-
al. Altern Ther Health Med 2010;16:30–38.
29 Sherr LJ: Moderators of the Effectiveness of a
Mindfulness-Based Stress Reduction Inter-
vention Compared to an Active Control for
Solid Organ Transplant Patients. University
of Minnesota, 2010.
30 Pinniger R, Thorsteinsson EB, Brown RF,
McKinley P: Tango dance can reduce distress
and insomnia in people with self-referred af-
fective symptoms. Am J Danc Ther 2013; 35:
60–77.
31 Carmody J, Crawford S, Salmoirago-Blotcher
E, Leung K, Churchill L, Olendzki N: Mind-
fulness training for coping with hot flashes:
Results of a randomized trial. Menopause
2011;18:611–620.
32 Schmidt S, Grossman P, Schwarzer B, Jena S,
Naumann J, Walach H: Treating fibromyal-
gia with mindfulness-based stress reduction:
results from a 3-armed randomized con-
trolled trial. Pain 2011;152:361–369.
33 Esmer G, Blum J, Rulf J, Pier J: Mindfulness-
based stress reduction for failed back surgery
syndrome: a randomized controlled trial. J
Am Osteopath Assoc 2010;110:646–652.
34 Ong JC, Manber R, Segal Z, Xia Y, Shapiro S,
Wyatt JK: A randomized controlled trial of
mindfulness meditation for chronic insom-
nia. Sleep 2014;37:1553–1163.
35 Zhang JX, Liu XH, Xie XH, Zhao D, Shan MS,
Zhang XL, Kong XM, Cui H: Mindfulness-
based stress reduction for chronic insomnia
in adults older than 75 years: a randomized,
controlled, single-blind clinical trial. Explore
(NY) 2015;11:180–185.
36 Black DS, O’Reilly GA, Olmstead R, Breen
EC, Irwin MR: Mindfulness meditation and
improvement in sleep quality and daytime
impairment among older adults with sleep
disturbances: a randomized clinical trial.
JAMA Intern Med 2015;175:494–501.
37 Gross CR, Kreitzer MJ, Reilly-Spong M, Wall
M, Winbush NY, Patterson R, Mahowald M,
Cramer-Bornemann M: Mindfulness-based
stress reduction versus pharmacotherapy for
chronic primary insomnia: a randomized
controlled clinical trial. Explore (NY) 2011;7:
76–87.
38 Spitzer RL, Kroenke K, Williams JB: Valida-
tion and utility of a self-report version of
PRIME-MD: The PHQ primary care study.
Primary care evaluation of mental disorders.
Patient health questionnaire. JAMA 1999;
282:1737–1744.
39 Diez-Quevedo C, Rangil T, Sanchez-Planell
L, Kroenke K, Spitzer RL: Validation and util-
ity of the patient health questionnaire in di-
agnosing mental disorders in 1003 general
hospital Spanish inpatients. Psychosom Med
2001;63:679–686.
40 Grafe K, Zipfel S, Herzog W, Lowe B: Screen-
ing for psychiatric disorders with the patient
health questionnaire (PHQ). Results from
the German validation study. Diagnostica
2004;50:171–181.
41 Segal ZV, Williams JM, Teasdale JD: Mind-
fulness-Based Cognitive Therapy for Depres-
sion. A New Approach to Preventing Relapse.
New York, Guilford Press, 2002.
42 Morin CM, Espie CA: Insomnia: A Clinical
Guide to Assessment and Treatment. New
York, Kluwer Academic/Plenum, 2003.
43 Morgenthaler T, Kramer M, Alessi C, Fried-
man L, Boehlecke B, Brown T, Coleman J,
Kapur V, Lee-Chiong T, Owens J, Pancer J,
Swick T: Practice parameters for the psycho-
logical and behavioral treatment of insomnia:
an update. An American academy of sleep
medicine report. Sleep 2006;29:1415.
44 Morin CM, Vallieres A, Guay B, Ivers H, Sa-
vard J, Merette C, Bastien C, Baillargeon L:
Cognitive behavioral therapy, singly and
combined with medication, for persistent in-
somnia: a randomized controlled trial. JAMA
2009;301:2005–2015.
45 Segal ZV, Teasdale JD, Williams JM, Gemar
MC: The mindfulness-based cognitive thera-
py adherence scale: Inter-rater reliability, ad-
herence to protocol and treatment distinc-
tiveness. Clin Psychol Psychother 2002; 9:
131–138.
46 Bastien CH, Vallieres A, Morin CM: Valida-
tion of the insomnia severity index as an out-
come measure for insomnia research. Sleep
Med 2001;2:297–307.
47 Yu DS: Insomnia severity index: psychomet-
ric properties with Chinese community-
dwelling older people. J Adv Nurs 2010; 66:
2350–2359.
48 Hou J, Wong SY, Lo HH, Mak WW, Ma HS:
Validation of a Chinese version of the five
facet mindfulness questionnaire in Hong
Kong and development of a short form. As-
sessment 2014;21:363–371.
49 Allison PD: Handling Missing Data by Maxi-
mum Likelihood. SAS Global Forum 2012,
Paper 312-2012.
50 Harvey AG, Belanger L, Talbot L, Eidelman
P, Beaulieu-Bonneau S, Fortier-Brochu E, Iv-
ers H, Lamy M, Hein K, Soehner AM, Mer-
ette C, Morin CM: Comparative efficacy of
behavior therapy, cognitive therapy, and cog-
nitive behavior therapy for chronic insomnia:
a randomized controlled trial. J Consult Clin
Psychol 2014;82:670–683.
51 Nakagawa S, Cuthill IC: Effect size, confi-
dence interval and statistical significance: a
practical guide for biologists. Biol Rev Camb
Philos Soc 2007;82:591–605.
52 Fava GA, Guidi J, Rafanelli C, Sonino N: The
clinical inadequacy of evidence-based medi-
cine and the need for a conceptual framework
based on clinical judgment. Psychother Psy-
chosom 2015;84:1–3.
165.123.34.86 - 7/3/2017 5:07:05 PM
Wong/Zhang/Li/Yip/Chan/Ling/Lo/Woo/
University of Pennsylvania
Sun/Ma/Mak/Gao/Lee/Wing
Downloaded by:
53 Passos GS, Poyares DL, Santana MG, Tufik S,
Mello MT: Is exercise an alternative treat-
ment for chronic insomnia? Clinics (Sao Pau-
lo) 2012;67:653–660.
54 Passos GS, Poyares D, Santana MG, Teixeira
AA, Lira FS, Youngstedt SD, dos Santos RV,
Tufik S, de Mello MT: Exercise improves im-
mune function, antidepressive response, and
sleep quality in patients with chronic primary
insomnia. Biomed Res Int 2014;2014:498961.
55 King AC, Oman RF, Brassington GS, Bliwise
DL, Haskell WL: Moderate-intensity exercise
and self-rated quality of sleep in older adults.
A randomized controlled trial. JAMA 1997;
277:32–37.
Mindfulness for Chronic Insomnia RCT
56 Garland SN, Carlson LE, Stephens AJ, Antle
MC, Samuels C, Campbell TS: Mindfulness-
based stress reduction compared with cogni-
tive behavioral therapy for the treatment of
insomnia comorbid with cancer: a random-
ized, partially blinded, noninferiority trial. J
Clin Oncol 2014;32:449–457.
57 Morin CM, Vallieres A, Guay B, Ivers H, Sa-
vard J, Merette C, Bastien C, Baillargeon L:
Cognitive behavioral therapy, singly and
combined with medication, for persistent in-
somnia: a randomized controlled trial. JAMA
2009;301:2005–2015.
58 Savard J, Ivers H, Villa J, Caplette-Gingras
A, Morin CM: Natural course of insomnia
comorbid with cancer: an 18-month longi-
tudinal study. J Clin Oncol 2011; 29: 3580–
3586.
Psychother Psychosom 2017;86:241–253
DOI: 10.1159/000470847
59 Morin CM, Bélanger L, LeBlanc M, Ivers H,
Savard J, Espie CA, Mérette C, Baillargeon L,
Grégoire JP: The natural history of insomnia:
a population-based 3-year longitudinal
study. Arch Intern Med 2009;169:447–453.
60 Kredlow MA, Capozzoli MC, Hearon BA,
Calkins AW, Otto MW: The effects of physi-
cal activity on sleep: a meta-analytic review. J
Behav Med 2015;38:427–449.
61 Miller CB, Espie CA, Epstein DR, Friedman
L, Morin CM, Pigeon WR, Spielman AJ, Kyle
SD: The evidence base of sleep restriction
therapy for treating insomnia disorder. Sleep
Med Rev 2014;18:415–424.
62 Harvey AG, Sharpley AL, Ree MJ, Stinson K,
Clark DM: An open trial of cognitive therapy
for chronic insomnia. Behav Res Ther 2007;
45:2491–2501.
165.123.34.86 - 7/3/2017 5:07:05 PM
253
University of Pennsylvania
Downloaded by: