Critical appraisal

For this RCT critical appraisal assignment, you will complete an appraisal of the following article=:

Here is a link to the article:

A randomized controlled trial of mindfulness in patients with schizophrenia

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Respond to this prompt following rubric guidelines as posted:

1- State your overall appraisal of this article (include/exclude/seek further info) and provide a rationale of approximately 2-3 paragraphs, citing evidence from the article, as to why you think the article is appropriate to include or not in the making of a clinically-based decision. This will be your response to the final question on the CASP RCT Checklist.
2- Complete the CASP RCT Checklist Download CASP RCT Checklist critical appraisal tool and use this information to guide your final thoughts on the usefulness of this article. Be sure to provide examples and support for your responses. Please do not simply answer “yes” or “no”.
3- Describe at least 1 important point that you learned about the appraisal process as a tool that is used before the findings from a study could be applied to clinical practice.

CASP Randomised Controlled Trial Standard Checklist:
11 questions to help you make sense of a randomised controlled trial (RCT)

Main issues for consideration: Several aspects need to be considered when appraising a
randomised controlled trial:

Is the basic study design valid for a randomised
controlled trial? (Section A)

Was the study methodologically sound? (Section B)
What are the results? (Section C)
Will the results help locally? (Section D)

The 11 questions in the checklist are designed to help you think about these aspects
systematically.

How to use this appraisal tool: The first three questions (Section A) are screening questions
about the validity of the basic study design and can be answered quickly. If, in light of your
responses to Section A, you think the study design is valid, continue to Section B to assess
whether the study was methodologically sound and if it is worth continuing with the appraisal by
answering the remaining questions in Sections C and D.

Record ‘Yes’, ‘No’ or ‘Can’t tell’ in response to the questions. Prompts below all but one of the
questions highlight the issues it is important to consider. Record the reasons for your answers
in the space provided. As CASP checklists were designed to be used as educational/teaching
tools in a workshop setting, we do not recommend using a scoring system.

About CASP Checklists: The CASP RCT checklist was originally based on JAMA Users’ guides to the
medical literature 1994 (adapted from Guyatt GH, Sackett DL and Cook DJ), and piloted with
healthcare practitioners. This version has been updated taking into account the CONSORT 2010
guideline (http://www.consort-statement.org/consort-2010, accessed 16 September 2020).

Citation: CASP recommends using the Harvard style, i.e. Critical Appraisal Skills Programme
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Available at: insert URL. Accessed: insert date accessed.

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Study and citation:

…………………………………………………………………………………………………………

Section A: Is the basic study design valid for a randomised controlled trial?

1. Did the study address a clearly focused
research question?

CONSIDER:

Was the study designed to assess the outcomes
of an intervention?
Is the research question ‘focused’ in terms of:
• Population studied
• Intervention given
• Comparator chosen
• Outcomes measured?

Yes No Can’t tell
o o

2. Was the assignment of participants to
interventions randomised?
CONSIDER:
• How was randomisation carried out? Was

the method appropriate?
• Was randomisation sufficient to eliminate

systematic bias?
• Was the allocation sequence concealed

from investigators and participants?

Yes No Can’t tell
o o o

3. Were all participants who entered the study
accounted for at its conclusion?
CONSIDER:
• Were losses to follow-up and exclusions

after randomisation accounted for?
• Were participants analysed in the study

groups to which they were randomised
(intention-to-treat analysis)?

• Was the study stopped early? If so, what
was the reason?

Yes No Can’t tell
o o o

Section B: Was the study methodologically sound?

4.
• Were the participants ‘blind’ to

intervention they were given?
• Were the investigators ‘blind’ to the

intervention they were giving to
participants?

• Were the people assessing/analysing
outcome/s ‘blinded’?

Yes No Can’t tell

o o o
o o

o o o

5. Were the study groups similar at the start of
the randomised controlled trial?
CONSIDER:
• Were the baseline characteristics of each

study group (e.g. age, sex, socio-economic
group) clearly set out?

• Were there any differences between the
study groups that could affect the
outcome/s?

Yes No Can’t tell
o o o

6. Apart from the experimental intervention, did
each study group receive the same level of
care (that is, were they treated equally)?

CONSIDER:
• Was there a clearly defined study protocol?
• If any additional interventions were given

(e.g. tests or treatments), were they similar
between the study groups?

• Were the follow-up intervals the same for
each study group?

Yes No Can’t tell
o o o

Section C: What are the results?

7. Were the effects of intervention reported

comprehensively?

CONSIDER:

•
• What outcomes were measured, and were

they clearly specified?
• How were the results expressed? For

binary outcomes, were relative and
absolute effects reported?

• Were the results reported for each
outcome in each study group at each
follow-up interval?

• Was there any missing or incomplete data?
• Was there differential drop-out between the

study groups that could affect the results?
• Were potential sources of bias identified?
• Which statistical tests were used?
• Were p values reported?

Yes No Can’t tell
o o o

8. Was the precision of the estimate of the
intervention or treatment effect reported?

CONSIDER:
• Were confidence intervals (CIs) reported?

Yes No Can’t tell
o o o

9. Do the benefits of the experimental
intervention outweigh the harms and costs?

CONSIDER:
• What was the size of the intervention or

treatment effect?
• Were harms or unintended effects

reported for each study group?
• Was a cost-effectiveness analysis

undertaken? (Cost-effectiveness analysis
allows a comparison to be made between
different interventions used in the care of
the same condition or problem.)

Yes No Can’t tell
o o o

Was a power calculation undertaken?

Section D: Will the results help locally?

10. Can the results be applied to your local
population/in your context?

CONSIDER:
• Are the study participants similar to the

people in your care?
• Would any differences between your

population and the study participants alter
the outcomes reported in the study?

• Are the outcomes important to your
population?

• Are there any outcomes you would have
wanted information on that have not been
studied or reported?

• Are there any limitations of the study that
would affect your decision?

Yes No Can’t tell
o o o

11. Would the experimental intervention provide
greater value to the people in your care than
any of the existing interventions?

CONSIDER:
• What resources are needed to introduce

this intervention taking into account time,
finances, and skills development or training
needs?

• Are you able to disinvest resources in one
or more existing interventions in order to
be able to re-invest in the new
intervention?

Yes No Can’t tell
o o o

APPRAISAL SUMMARY:

Record key points from your critical appraisal in this box. What is your
conclusion about the paper? Would you use it to change your practice or to recommend changes to
care/interventions used by your organisation? Could you judiciously implement this intervention
without delay?

Section D Will the results help locally:
Check Box2: Off
Q:

1 consideration answers:

2 consideration answers:

3 consideration answers:

5 consideration answers:

6 consideration answers:

7 consideration answers:

8 consideration answers:

9 consideration answers:

10 consideration answers:

11 consideration answers:

Check Box3: Off
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Check Box7: Off
Check Box9: Off
Check Box10: Off
Check Box11: Off
Check Box13: Off
Check Box14: Off
Check Box15: Off
Check Box12: Off
Check Box16: Off
Check Box17: Off
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Check Box19: Off
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APPRAISAL SUMMARY:

Contents lists available at ScienceDirect

Psychiatry Research

journal homepage: www.elsevier.com/locate/psychres

A randomized controlled trial of mindfulness in patients with
schizophrenia✰

Kun-Hua Lee
Department of Educational Psychology and Counseling, National

sing Hua University, 521 Nan-Da Road, Hsinchu City 30014, Taiwan

A R T I C L E I N F O

Keywords:
Mindfulness
Negative symptoms
PANSS
Schizophrenia
GEE

A B S T R A C T

Cognitive Behavioral Therapy (CBT) is frequently used to attenuate the severity of positive schizophrenia
symptoms; however, few studies have focused on attenuating negative symptoms. Recently, researchers have
become interested in the effects of mindfulness-based intervention (MBI) on schizophrenia, but the lack of
evidence-based results from random clinical trials (RCTs) has limited their effectiveness. Moreover, longitudinal
data must be examined using appropriate study designs. We recruited 60 schizophrenia patients and randomly
assigned them to an MBI or to a treatment-as-usual group. Negative symptoms, positive symptoms, mindfulness,
and depression were assessed at baseline, post-course, and at a 3-month follow-up. Descriptive analysis and
generalized estimating equations (GEEs) were used to examine the effects of MBI. We found that MBI mitigated
the severity of negative symptoms and of general schizophrenic psychopathology except for the positive
symptoms and for those of depression. Unexpectedly, we did not find long-term effect of mindfulness on negative
symptoms. Larger sample sizes, long-term practical course, more rigorous study procedures, and a double-blind
design should be considered in future studies.

1. Introduction

The lifetime prevalence of schizophrenia has been estimated to be
0.4% (Saha et al., 2005), and for decades schizophrenia has been
considered and treated as a severe mental disease. Simeone et al. (2015)
reported that the median prevalence of schizophrenia in 2014 was
0.33%, and that the worldwide lifetime prevalence was 0.49%. The
overall prevalence in China ranged between 0.044% and 0.066%
(Long et al., 2014). The prevalence of schizophrenia has been stable
throughout the past few decades, and because the disease is extremely
burdensome to schizophrenia patients and their caregivers (Hsiao and
Tsai, 2014), efficacious treatments should be a biomedical priority.
Better therapies would give patients and their caregivers more con-
fidence about how to maintain a balanced and healthy lifestyle and,
undoubtedly, more motivation to actually do it.

Cognitive Behavioral Therapy (CBT) is a strongly recommended
management strategy for schizophrenia (Brus et al., 2012). CBT was
originally developed to ameliorate depression and anxiety, and it was
assumed that depression and its sequelae were maladaptive beliefs
caused by disturbing life events (Roth et al., 2002). To treat schizo-
phrenia, CBT was modified to focus on the beliefs about the symptoms
and on how to cope with them by guiding the questions (Dickerson and
Lehman, 2011). Evidence confirms that CBT has a strong attenuating

effect on the severity of positive symptoms in patients with acute
schizophrenia, but that it has only a small-to-moderate effect on the
relapse of positive and negative symptoms (Hoffman et al., 2012). Ef-
fective schizophrenia intervention should focus on subjective well-
being and quality of life, increased functional performance, and pre-
venting relapses (Dickerson and Lehman, 2011).

More evidence that supports the beneficial effects of mindfulness-
based intervention (MBI) on schizophrenia is accumulating
(Khoury et al., 2013). Of five patients with severe schizophrenia who
underwent eight MBI sessions and regular daily meditation for eight
months, all reported significant mitigation in the severity of their hal-
lucinations and delusions (Sheng et al., 2018). Moreover, a cross-sec-
tional study (Dudley et al., 2018) reported that a higher extent of
mindfulness attenuated distress when patients heard voices, and that
self-compassion partially mediated between mindfulness on the severity
of voices and distress. This indicates that mindfulness can be important
for reducing the severity of symptoms and for increasing quality of life
and subjective well-being.

MBI is a kind of psychological and behavioral practice based on
Buddhist meditation, and it focuses on the awareness that emerges
through purposely and nonjudgmentally paying attention in the present
moment to the moment-by-moment unfolding of experience (Kabat-
Zin, 2003). Practitioners of MBI for schizophrenia claim that its patients

https://doi.org/10.1016/j.psychres.2019.02.079
Received 28 November 2018; Received in revised form 1 February 2019; Accepted 1 February 2019

✰Conflict of Interest: Kun-Hua Lee has no conflicts of interest related to this study.
E-mail addresses: kunhualee@mail.nthu.edu.tw, kunhualee@mx.nthu.edu.tw.

Psychiatry Research 275 (2019) 137–

142

Available online 19 March 2019
0165-1781/ © 2019 Elsevier B.V. All rights reserved.

http://www.sciencedirect.com/science/journal/01651781

https://www.elsevier.com/locate/psychres

https://doi.org/10.1016/j.psychres.2019.02.079

mailto:kunhualee@mail.nthu.edu.tw

mailto:kunhualee@mx.nthu.edu.tw

https://doi.org/10.1016/j.psychres.2019.02.079

http://crossmark.crossref.org/dialog/?doi=10.1016/j.psychres.2019.02.079&domain=pdf

have reported relaxation, relief from psychological symptoms, cognitive
change, and focus on the present (Brown et al., 2010). Schizophrenia
patients developed emotions and beliefs that were more adaptive, and
they said that MBI motivated them to more closely maintain balanced
and healthy lifestyles (Tabak et al., 2015). However, many questions
about the efficacy of MBI and the mechanism of mindfulness on schi-
zophrenia await resolution (Chadwick, 2014).

Although confirmatory evidence of the benefits of MBI for schizo-
phrenia patients is currently being reported by randomized clinical
trials (RCTs), there are limits to its ability to attenuate schizophrenia
symptoms, especially negative symptoms (Cramer et al., 2016). In Hong
Kong, a larger-scale (n=107) RCT on the effects of MBI on schizo-
phrenia patients showed significantly ameliorated positive and negative
symptoms after six months compared with patients who underwent
only treatment-as-usual (TAU) (Chien and Thompson, 2014).

In the past, the paired t-test and analysis of variance (ANOVA) were
frequently used to evaluate follow-up and longitudinal data. However,
ANOVA and repeated measurements could not precisely present the
changes of an individual to limit the effectiveness of intervention
(Zeger et al., 1988). Generalized Estimating Equations (GEEs) can be
used to analyze normal and non-normal data in RCTs and longitudinal
studies (Bell et al., 2018). In the present study, we not only examined
the effectiveness of mindfulness-based intervention on negative symp-
toms and psychotic symptoms, but also profiled the trend of changes in
outcome measures on schizophrenia. Thus, we used GEEs to analyze our
follow-up data.

In sum, the present study aimed to use randomly assigned and GEE
analyses to examine the effect of MBI on the severity of psychotic
symptoms in schizophrenia patients. We hypothesized that:

(1) At baseline, there would be no significant differences in the seve-
rities of positive symptoms, negative symptoms, general psychotic
symptoms, and depression between the MBI and TAU groups.

(2) At baseline, there would be no significant differences in the extent
of mindfulness between the MBI and TAU groups.

(3) Post-course, the severity of positive and negative symptoms in the
MBI group would be significantly lower than in the TAU group.

(4) Post-course, the extent of mindfulness in the MBI group would be
significantly higher than in the TAU group.

(5) At the 3-month follow-up, the severity of positive and negative
symptoms in the MBI group would be significantly lower than in the
TAU group.

(6) At the 3-month follow-up, the extent of mindfulness in the MBI
group would be significantly higher than in the TAU group.

2. Methods

2.1. Study design

This RCT examined the effects of MBI on schizophrenia patients.
PANSS scores at baseline, post-course, and follow-up between the MBI
and TAU groups have been analyzed using repeated measures
(Hsieh et al., 2018).

2.2. Patients and procedures

We recruited 60 schizophrenia patients from rehabilitation wards
and daycare centers in mental hospitals in eastern Taiwan. All were
referred by psychiatrists, nurses, occupational therapists, clinical psy-
chologists, or volunteers. Yuli Hospital’s Institutional Review Board
approved the study protocol (YLH-IRB-10307). Inclusion criteria were
(a) being 18–65 years old, (b) being diagnosed on the schizophrenia
spectrum, (c) being able to read and write Taiwanese Mandarin
Chinese, and (d) having at least an elementary school education.
Patients with (a) psychotic symptoms, (b) delirium, or (c) extensive
suicidal ideation, or (d) patients who were violent were excluded.

The research assistant stated the purpose of this project and ex-
plained each patient’s personal rights and potential risks before they
signed a written informed consent. Patients were then randomly as-
signed to the mindfulness group (MBI; n=30) or to the treatment-as-
usual group (TAU; n=30). Before undergoing MBI, the baseline se-
verity of the positive and negative symptoms, and the extent of the
mindfulness, were all assessed. The research assistant was responsible
for the interview and assisted participants on the completion of the self-
report questionnaires. Two assessors were trained by experienced
clinical psychologists. Before assessing, the principal researcher as-
sessed the same participant with the assessors and discussed any in-
consistent scores in order to improve the consensus. The same assess-
ments were made after eight weeks of MBI and at the three-month
follow-up. The CONSORT flowchart is shown in Fig. 1.

2.3. Interventions

2.3.1. Mindfulness-based interventions
We developed an eight-session, 1.5-h weekly MBI program for

schizophrenia based on a self-awareness, self-regulation, and self-
transcendence (S-ART) model of mindfulness (Vago and
Silbersweig, 2012). S-ART assumes that mindfulness practice effica-
ciously regulates the behaviors, increases the awareness, and maintains
a positive relationship between each patient’s self and others. In the
present study, the eight weeks of MBI primarily focused on practicing
self-awareness and self-regulation. Three groups were led by six senior
clinical psychologists who had undergone a 3-day MBI workshop and
maintained daily mindfulness practice. During the 3-day workshop,
trained therapists were taught the concepts of mindfulness, mindfully
eating, mindfully walking, mindful yoga, mindful meditation, and

Fig. 1. CONSORT flowchart.
*: The participants who did not complete at least four sessions were treated as
the participants who failed to intervention.

K.-H. Lee Psychiatry Research 275 (2019) 137–142

138

mindful self-compassion. After the workshop, they were asked to
practice mindfulness daily throughout the week.

In the first week, patients were introduced to the concept of
mindfulness and asked to meet the expectations of the MBI group.
Homework was assigned at the end of each session. The second week,
we invited the patients to play simple puzzle games to stimulate their
curiosity. We then taught them a 15-min breathing mediation, which
was assigned as daily homework. The third week, we invited the pa-
tients to mindfully write their name after their homework review. The
fourth week, we taught them to mindfully eat and to allow themselves
to experience the effect of habitual behaviors after their homework
review. The fifth week, we asked the patients to mindfully read and
write a short paper. In the sixth and seventh weeks, we asked them to
mindfully stretch. The eighth week, we taught them self-compassionate
meditation to increase their capacity for self-care and prosocial beha-
vior. Each week, a 15-min breathing meditation was done before we
gave the patients feedback and their homework assignment.

2.3.2. Treatment-as-Usual
All of our participants were recruited from rehabilitation wards and

daycare centers. Before entering this study, all of the participants with
residual symptoms were treated with routinely scheduled rehabilita-
tions, such as, walking 5000 steps every morning, occupational re-
habilitation twice a week, nutrition counseling, nursing care, health
education group, mild doses of antipsychotic drugs, and other routine
mental hospital activities. Thus, the participants in the TAU group were
asked to maintain their routine activities.

2.4. Measurements

2.4.1. Personal information: included ID, gender, age, and length of formal
education
2.4.1.1. Chinese version of the mindfulness attention awareness scale
(MAAS). This scale was developed by Brown and Ryan (2003) to
assess the extent of dispositional mindfulness. It is sensitive to
improvements in the extent of a patient’s mindfulness.
Chang et al. (2011) translated the MAAS into Chinese and reported
that it had good reliability and validity. It assesses fifteen items rated
from 1 (Never) to 6 (Always). Higher scores mean a lower level of
mindfulness.

2.4.1.2. Beck depression inventory (BDI-II). The scale was developed to
assess the severity of depressive symptoms (Beck et al., 1988). There are
21 items rated from 0 to 4 that ask about different depression
symptoms. Higher scores mean more severe depressive symptoms
(Walter et al., 2003). Cronbach’s α of the BDI-II after 8 sessions in
this study was 0.90.

2.4.1.3. Scale for assessment of negative symptoms (SANS). The scale was
developed by Andreasen (1982) to assess the severity of negative
symptoms. Twenty-three items are rated from 0 (None) to 5 (Severe).
Higher scores mean more severe negative symptoms. The reliabilities of
the five subscales were: affective flattening (0.86), alogia (0.89),
avolition (0.68), anhedonia (0.74), and attention impairment (0.86)
(Andreasen et al., 2003).

2.4.1.4. Chinese Mandarin version of the positive and negative syndrome
scale (CMV-PANSS). The PANSS includes 30 items rated from 1 to 7
that assess the severity of the positive and negative symptoms and of
the general psychopathology of patients with schizophrenia. Higher
scores mean more severe symptoms. The CMV-PANSS showed good
reliability (Cronbach’s α=0.928) (Wu et al., 2015).

2.5. Statistical analysis

Intention to treat analysis (ITT) was used in the present study for

two reasons (Gupta, 2011). First, ITT ignores noncompliance and
withdrawal. Second, ITT preserved sample size in the present study.
Our sample was small because it was difficult to recruit patients. De-
scriptive analyses, t-tests, and χ2 tests were used to determine the dis-
tributions of demographic and outcome variables in the two groups.
Generalized Estimating Equations (GEEs) are frequently recommended
for analyzing longitudinal data when the data are not normally dis-
tributed and the variance of the outcome variables are not constant
(Ghisletta and Spini, 2004). In the present study, GEEs were used to
examine pre-course, post-course, and follow-up data. Significance was
set at p < 0.05.

3. Results

3.1. Demographic data

Only 50 of the recruited patients completed the study: 3 dropped
out because of occupational training, 3 contracted influenza A infec-
tion, 3 dropped out for personal reasons, and 1 had an acute psychotic
episode before the intervention (see Fig. 1). The mean age of MBI group
members was 54.43 ± 6.32 years and of TAU group members was
51.15 ± 6.32 years. There were no significant differences in the se-
verity of SANS (t= ‒1.649, df= 56, p=0.105), PANSS (t= ‒0.788,
df= 55, p=0.434), depressive symptoms (t=0.296, df= 56,
p=0.768), or the level of mindfulness (t=0.566, df= 56, t=0.574)
between dropouts and patients who completed the study, except for age
(t= ‒3.313, df= 57, p=0.002).

At baseline, there were no significant differences between the MBI
and TAU groups in sex (χ2= 1.482, df= 1, p=0.223) or educational
level (χ2= 6.663, df= 4, p=0.155), but TAU group members were
significantly older than were the MBI group members (t=2.722,
df= 57, p=0.009). There were no significant differences in outcome
measures between the MBI and TAU groups in PANSS (t= ‒0.388,
df= 55, p=0.699), SANS (t= ‒0.947, df= 56, p=0.347), level of
mindfulness (t= ‒1.793, df= 56, p=0.078), and depressive symp-
toms (t= ‒0.610, df= 56, p=0.545) (Table 1).

3.2. GEE data

We treated age as a covariant because of the significant difference in
age between the MBI and TAU groups.

3.2.1. The effects of mindfulness-based intervention on negative symptoms
GEE analysis showed a significant main effect of group on SANS

(β=0.661, p=0.011) and a significant main effect of time on SANS at
time 1 (β=0.986, p=0.000). The effect of group× time on SANS
reached was significant after baseline (β= ‒0.973, p=0.000) but not
significant after the post-course (β= ‒0.1, p=0.53).

The main effects of group (β=0.996, p=0.000) and at time 1
(β=0.508, p=0.011) were also significant for the changes of the
negative symptoms subscale for PANSS. The effect of time× group
after baseline was marginally significant (β= ‒0.439, p=0.049) but
not significant after the post-course (β=0.18, p=0.44) (see Fig. 2).

3.2.2. The effect of mindfulness-based intervention on psychotic symptoms
GEE analysis showed a significant main effect of group on the total

scores of PANSS (β=0.24, p=0.03) and a significant main effect of
time on the total scores of PANSS at time 1 (β= ‒0.223, p=0.000).
The effect of group× time on the total scores of PANSS was significant
after baseline (β= ‒0.363, p=0.00) but not significant after the post-
course (β= ‒0.07, p=0.52) (see Fig. 3).

The main effect of group on the changes in the general psycho-
pathology subscale for PANSS was significant after baseline (β= ‒0.48,
p=0.00) but the main effect s of time (β=0.22, p=0.049) was
marginally significant. The effect of time× group after baseline was
also significant (β= ‒0.43, p=0.01).

K.-H. Lee Psychiatry Research 275 (2019) 137–142

139

The main effect of group on the changes of the positive symptoms
subscale for PANSS was not significant (β= ‒0.03, p=0.76) but the
main effect of time after baseline was significant (β= ‒1.01, p=0.00).
The effect of time× group after baseline was not significant after
baseline (β= ‒0.14, p=0.40) or after the post-course (β=0.06,
p=0.65). (see Fig. 3)

3.2.3. The effects of mindfulness-based intervention on depression and the
level of mindfulness

The main effects of group and time on depression were not sig-
nificant at baseline (β= ‒0.15, p=0.20; β=0.04, p=0.76). The ef-
fect of group× time on depression was significant after baseline and

after the post-course (β=0.12, p=0.39; β=0.22, p=0.07) (See
Fig. 4).

The main effect of group on mindfulness was not significant
(β=0.01, p=0.95), but the main effect of time on mindfulness was
significant (β= ‒0.30, p=0.01). The effect of group× time on
mindfulness was not a significant after baseline or after the post-course
(β= ‒0.16, p=0.38; β=0.25, p=0.22).

4. Discussion

4.1. Synthesis and interpretation of findings

We used an RCT design and GEEs to examine the effects of MBIs on
the severity of the positive and negative symptoms of schizophrenia, on
its depression, and on the extent of mindfulness in schizophrenia pa-
tients. After eight sessions mindfulness-based interventions, MBI group
patients reported lower levels of SANS than did those in the TAU group,
but at the 3-month follow-up there was no significant difference in
SANS. The negative symptom subscale of PANSS in the MBI group was
significantly lower at the 3-month follow-up than at baseline, but it was
not in the TAU group. There was no significant difference in positive
symptoms between the groups post-course or at the 3-month follow-up.
The level of general psychopathology of MBI group patients rose more
slowly from baseline to the 3-month follow-up than in the TAU group.

First, we found that, after the interventions, the SANS of the MBI
group patients was better (lower) than that of the Tau group patients.
Despite a slight rise during the follow-up, the severity of the MBI
group’s negative symptoms continued to be significantly lower. This
was consistent with Johnson et al. (2009), a qualitative study in which
patients used breathing and loving-kindness meditation to reduce the
severity of negative symptoms. Patients had positive emotions and felt
closer to family and friends during these two MBIs; they were peaceful
and more concentrated on the here-and-now when they practiced
breathing meditation. Therefore, the severities of anhedonia and at-
tention impairment were attenuated.

Second, in addition to SANS, the negative symptom subscale levels
of PANSS significantly decreased over time in the MBI group at post-
course and during the follow-up. Our findings were consistent with
those of Chien and Lee (2013). Moreover, our findings preliminarily
supported the efficacy of MBIs for improving the negative symptoms of
schizophrenia. Schizophrenia patients are encouraged to actively be
aware of and to experience life through mindfully eating and mindfully
stretching. Therefore, they have to refocus on their everyday activities
and reengage with them to be aware of and to share them. The negative
symptoms of avolition and affective flattening were attenuated after
these MBIs. Future studies might want to examine the unique effects of
each MBI on schizophrenia.

Third, we were unable to confirm the effect of mindfulness on the
positive symptom scale of PANSS in the present study. Our data were

Table 1
Longitudinal outcome measures between TAU and MBI.

MBI (N=20) TAU(N=30)
Mean S.D Mean S.D

SANS
Baseline 1.95 0.74 1.64 0.48
Post-course 0.95 0.96 1.52 0.81
3-month follow up 0.89 0.20 0.94 0.17

PANSS
Baseline 2.41 0.34 2.28 0.64
Post-course 2.68 0.39 2.98 0.43
3-month follow up 2.86 0.07 2.63 0.09

Mindfulness
Baseline 1.69 0.24 1.54 0.31
Post-course 1.91 0.50 2.16 0.82
3-month follow up 3.97 1.12 3.98 1.43

Depression
Baseline 0.46 0.20 0.42 0.26
Post-course 0.40 0.48 0.47 0.44
3-month follow up 0.42 0.48 0.27 0.26

Positive symptoms
Baseline 2.13 0.41 1.96 0.62
Post-course 3.10 0.29 3.12 0.26
3-month follow up 3.14 0.23 3.10 0.08

Negative symptoms
Baseline 3.09 0.80 3.13 1.64
Post-course 2.45 0.90 3.06 0.88
3-month follow up 2.10 0.63 2.58 0.81

General
Baseline 2.35 0.35 2.15 0.60
Post-course 2.79 0.32 3.07 0.40
3-month follow up 2.82 0.31 3.08 0.50

SANS: Scale for Assessment Negative Symptoms; PANSS: Chinese Mandarin
version Positive and Negative Syndrome Scale; Positive: the positive subscale of
Chinese Mandarin version Positive and Negative Syndrome Scale; Negative: the
negative subscale of Chinese Mandarin version Positive and Negative Syndrome
Scale; General: the general psychopathology of Chinese Mandarin version
Positive and Negative Syndrome Scale; Mindfulness: Chinese version of
Mindfulness Attention Awareness Scale; Depression: Beck Depression Inventory
Ⅱ; *:p < 0.05; **:p < 0.01.

Fig. 2. Changes of negative symptoms between MBI and TAU.

K.-H. Lee Psychiatry Research 275 (2019) 137–142

140

inconsistent with those of Chien and Lee (2013). However, few studies
have examined the effects of MBIs on positive symptoms by directly
assessing PANSS or by measuring positive symptoms. For example,
Chadwick et al. (2005) used the Clinical Outcomes in Routine Evalua-
tion Outcome Measure (CORE-OM) to assess the changes of positive
symptoms after MBI, and they reported that overall psychotic symp-
toms were mitigated by breathing meditation. In the present study, the
effects of group and of time on negative symptoms were significant. The
effect of time by group was not significant, possibly because the severity
of negative symptoms is not stable and gradually improves even
without interventions. A meta-analysis (Savill et al., 2015) claimed that
the severity of negative symptoms decreased across all conditions, but
more longitudinal studies are required to confirm this.

Fourth, we found that general levels of the psychopathology of
schizophrenia had been mitigated after MBI, which is consistent with
Chien and Thompson (2014). The schizophrenia patients in the present
study were asked to read mindfully and to do breathing and loving-

kindness meditation for others and for themselves. These practices not
only helped patients learn to calm down, but also taught them to be-
come aware of and able to regulate their emotions. Theoretically,
schizophrenia patients who accept MBIs can regulate the pathways of
their brain circuits, especially for amygdala and other emotional-load
pathways (Dickerson and Lehman, 2011; Dudley et al., 2018). The
biomarker of mindfulness should be identified in future studies.

Fifth, we found in our study no significant difference in the extent of
mindfulness between the MBI and TAU groups. Despite our finding of a
marginal effect of time by group, this is inconsistent with Chien and
Thompson (2014). One possible explanation is that the MBI in the
present study was short-term. It was also shorter than that of
Sheng et al. (2018), who claimed that long-term practice to cultivate
mindfulness is necessary. Further study should increase the times of
mindfulness-based course for schizophrenia in order to deeply cultivate
the level of mindfulness.

Sixth, we found no significant differences in depression severity

Fig. 3. Changes of positive symptoms and general psychopathology between MBI and TAU.

Fig. 4. Changes of depression and mindfulness between MBI and TAU.

K.-H. Lee Psychiatry Research 275 (2019) 137–142

141

over time or between subjects, which did not support
Brown et al. (2010). One possible explanation is the severity of de-
pressive symptoms. In the present study, the average levels of depres-
sion at baseline, post-course, and during the 3-month follow-up were
9.27, 8.98, and 7.16, respectively. Thus, the BDI-Ⅱ means mentioned
above were at normal depression levels. Therefore, future studies might
consider inviting participants with more severe depressive symptoms in
order to examine the effects of MBIs on depression in schizophrenia.

4.2. Limitations

Our study has some limitations. First, because our sample was small,
our findings cannot be generalized to other populations. A large sample
should be used in future studies. Second, the doses of prescribed
medications and relevant information about symptom or disease onset
could not be collected in this study. Third, despite being asked to ob-
jectively measure the severity of negative symptoms or general psy-
chopathology, the assessors were not blinded to the treatment and
control groups. A double-blind study should be conducted in the future.
Finally, although practicing MBIs at home was assigned after each
session, we did not assess patient adherence. According to therapists’
feedback, the participants in the MBI group reported that they had
completed their home practice after each session. Patient adherence
should be assessed in future studies. Although our study was an RCT,
our findings did not fully support the efficacity of MBI because we did
not compare it with another type of active intervention. Future studies
should compare MBI with other types of schizophrenia interventions.

5. Conclusions

Our findings preliminarily support the efficacy of MBI for schizo-
phrenia. Additional studies are needed to explain the mechanism of
mindfulness and to confirm its efficacy for schizophrenia.

Compliance with ethical standards

Funding: This study was funded by Yuli Hospital, Taiwan Ministry of
Health and Welfare (grant number: YHL-IRP-10404).

Ethical approval: All procedures performed in studies involving
human participants were in accordance with the ethical standards of
the institutional and national research committees and with the 1964
Helsinki declaration and its later amendments or comparable ethical
standards.

Supplementary materials

Supplementary material associated with this article can be found, in
the online version, at doi:10.1016/j.psychres.2019.02.079.

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A randomized controlled trial of mindfulness in patients with schizophrenia✰

Introduction

Methods

Study design

Patients and procedures

Interventions

Mindfulness-based interventions

Treatment-as-Usual

Measurements

Personal information: included ID, gender, age, and length of formal education

Chinese version of the mindfulness attention awareness scale (MAAS)

Beck depression inventory (BDI-II)

Scale for assessment of negative symptoms (SANS)

Chinese Mandarin version of the positive and negative syndrome scale (CMV-PANSS)

Statistical analysis

Results

Demographic data

GEE data

The effects of mindfulness-based intervention on negative symptoms

The effect of mindfulness-based intervention on psychotic symptoms

The effects of mindfulness-based intervention on depression and the level of mindfulness

Discussion

Synthesis and interpretation of findings

Limitations

Conclusions

Compliance with ethical standards

Supplementary materials

References

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