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Group Mindfulness-Integrated Cognitive Behavior Therapy (MiCBT) Reduces Depression and Anxiety and Improves Flourishing in a Transdiagnostic Primary Care Sample Compared to Treatment-as-Usual: A Randomized Controlled Trial

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Frontiers in Psychiatry
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Objectives This study investigated the effectiveness of a group-based 8-week intervention, Mindfulness-integrated Cognitive Behavior Therapy (MiCBT), to decrease psychological distress and increase wellbeing in a heterogeneous population in primary health care. MiCBT focuses on the importance of interoception and its interaction with cognition in emotional experience. These interactions are represented in the co-emergence model of reinforcement, in which non-reactivity (equanimity) to interoceptive signals facilitates adaptive behavior. Methods Participants (n = 125, aged 20–72) were randomized to two groups (MiCBT), and treatment-as-usual (TAU). Outcomes were assessed at pre-, mid-, and post-intervention and at 6-month follow-up. The primary outcome was psychological distress, measured by the Depression, Anxiety and Stress Scale (DASS-21). Secondary outcome measures were the Kessler Psychological Distress Scale-10 (K10), Satisfaction with Life Scale (SWLS), and Flourishing Scale (FS). Mediator or process measures of interoceptive awareness, metacognitive awareness (decentering), equanimity, and social functioning were included to investigate putative mediators. Results The MiCBT intervention significantly reduced DASS-21 scores at mid and post-treatment and the gains were maintained at 6-month follow-up (p < 0.0001, d = 0.38). Flourishing scores also showed significant improvement post-treatment and at 6-month follow-up (d = 0.24, p < 0.0001). All measures selected showed a similar pattern of positive change, with the exception of the SWLS, which failed to reach significance. Mediation analysis suggested equanimity to be the most influential mediator of the primary outcome. Conclusions The results support the effectiveness of MiCBT in creating rapid and sustainable reduction of psychological distress and improvement in flourishing in a primary mental health care setting with heterogenous groups. These promising results support the scaled-up implementation of this intervention. Clinical Trial Registration This trial is registered with the Australian and New Zealand Clinical Trial Registry: https://www.anzctr.org.au/ACTRN12617000061336.
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ORIGINAL RESEARCH
published: 31 May 2022
doi: 10.3389/fpsyt.2022.815170
Frontiers in Psychiatry | www.frontiersin.org 1May 2022 | Volume 13 | Article 815170
Edited by:
Chienchung Huang,
The State University of New Jersey,
United States
Reviewed by:
Yuanfa Tan,
Southwestern University of Finance
and Economics, China
Saul Neves Jesus,
University of Algarve, Portugal
*Correspondence:
Sarah E. B. Francis
contact@melbournemindfulness.com
Specialty section:
This article was submitted to
Anxiety and Stress Disorders,
a section of the journal
Frontiers in Psychiatry
Received: 15 November 2021
Accepted: 26 April 2022
Published: 31 May 2022
Citation:
Francis SEB, Shawyer F, Cayoun B,
Enticott J and Meadows GN (2022)
Group Mindfulness-Integrated
Cognitive Behavior Therapy (MiCBT)
Reduces Depression and Anxiety and
Improves Flourishing in a
Transdiagnostic Primary Care Sample
Compared to Treatment-as-Usual: A
Randomized Controlled Trial.
Front. Psychiatry 13:815170.
doi: 10.3389/fpsyt.2022.815170
Group Mindfulness-Integrated
Cognitive Behavior Therapy (MiCBT)
Reduces Depression and Anxiety and
Improves Flourishing in a
Transdiagnostic Primary Care
Sample Compared to
Treatment-as-Usual: A Randomized
Controlled Trial
Sarah E. B. Francis 1
*, Frances Shawyer 1, Bruno Cayoun 2, Joanne Enticott 1,3 and
Graham N. Meadows 1,4,5
1Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne,
VIC, Australia, 2Mindfulness-Integrated Cognitive Behavior Therapy Institute, Hobart, TAS, Australia, 3Monash Centre for
Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC,
Australia, 4Mental Health Program, Monash Health, Melbourne, VIC, Australia, 5Melbourne School of Population and Global
Health, University of Melbourne, Parkville, VIC, Australia
Objectives: This study investigated the effectiveness of a group-based 8-week
intervention, Mindfulness-integrated Cognitive Behavior Therapy (MiCBT), to decrease
psychological distress and increase wellbeing in a heterogeneous population in primary
health care. MiCBT focuses on the importance of interoception and its interaction
with cognition in emotional experience. These interactions are represented in the co-
emergence model of reinforcement, in which non-reactivity (equanimity) to interoceptive
signals facilitates adaptive behavior.
Methods: Participants (n=125, aged 20–72) were randomized to two groups (MiCBT),
and treatment-as-usual (TAU). Outcomes were assessed at pre-, mid-, and post-
intervention and at 6-month follow-up. The primary outcome was psychological distress,
measured by the Depression, Anxiety and Stress Scale (DASS-21). Secondary outcome
measures were the Kessler Psychological Distress Scale-10 (K10), Satisfaction with Life
Scale (SWLS), and Flourishing Scale (FS). Mediator or process measures of interoceptive
awareness, metacognitive awareness (decentering), equanimity, and social functioning
were included to investigate putative mediators.
Results: The MiCBT intervention significantly reduced DASS-21 scores at mid and post-
treatment and the gains were maintained at 6-month follow-up (p<0.0001, d=0.38).
Flourishing scores also showed significant improvement post-treatment and at 6-month
follow-up (d=0.24, p<0.0001). All measures selected showed a similar pattern of
positive change, with the exception of the SWLS, which failed to reach significance.
Francis et al. MiCBT Reduces Depression and Anxiety
Mediation analysis suggested equanimity to be the most influential mediator of the
primary outcome.
Conclusions: The results support the effectiveness of MiCBT in creating rapid and
sustainable reduction of psychological distress and improvement in flourishing in a
primary mental health care setting with heterogenous groups. These promising results
support the scaled-up implementation of this intervention.
Clinical Trial Registration: This trial is registered with the Australian and New Zealand
Clinical Trial Registry: https://www.anzctr.org.au/ACTRN12617000061336.
Keywords: mindfulness, equanimity, transdiagnostic treatment, interoception, Mindfulness-integrated Cognitive
Behavior Therapy (MiCBT)
INTRODUCTION
Comorbidities are common in mental health conditions (13)
and have been associated with greater use of health services but
also worse outcomes (4). In order to address co-morbidities,
transdiagnostic protocols—protocols that can be applied across
a range of processes such as cognitive-behavioral, interpersonal,
or biological—have been attracting attention (5,6). A number
of psychological processes are proposed to be transdiagnostic
including ruminative negative thinking, biased reasoning,
selective attention to stimuli (both internal and external)
and avoidance (5,7). Interventions that can address such
psychological processes could therefore be used to treat multiple
conditions, both within and across individuals, obviating the
need to tailor the content to particular diagnostic groups (8,9).
Despite recent attention to transdiagnostic approaches, therapies
for mental health conditions, including traditional cognitive-
behavioral therapies (CBT), and more recently mindfulness-
based therapies are, in the main, disorder specific following a
medical diagnostic model (6).
Mindfulness-integrated Cognitive Behavior Therapy
[MiCBT—(1012)] potentially makes a valuable contribution
to the emerging suite of transdiagnostic interventions because
it addresses a number of transdiagnostic processes including
metacognitive awareness (discernment and regulation of
reasoning), selective attention to stimuli (both internal and
external), and avoidance. Additionally, MiCBT addresses
emotion regulation which has been proposed to be a
transdiagnostic factor (13). Emotion regulation is addressed
through the development of interoceptive awareness (awareness
of body sensations) together with equanimity. Equanimity has
been defined “as an even-minded mental state or dispositional
tendency toward all experiences or objects, regardless of their
origin or their affective valence (pleasant, unpleasant, or
neutral)” [(14), p. 4] and could be simplistically defined as
non-reactivity. MiCBT proposes that emotional reactivity is
based on conditioning to interoceptive signals and that the
development of equanimity to interoceptive signals through
exposure (e.g., while scanning the body during mindfulness
meditation) facilitates extinction processes.
Both interoceptive signals and the cognitive evaluation of the
internal and external environment are recognized as contributing
to an emotional experience (1517). In the case of a fear
experience that is evaluated as threatening, the level of arousal
increases the production of interoceptive signals as part of the
emotional experience thus setting up expectations for future
similar situations. If the interoceptive signals can be cognitively
re-evaluated as non-threatening then the learned response can
be extinguished (18). It is now established that interoceptive
awareness is impaired in people with mental health disorders
(19,20)—for example, with heightened interoception (e.g., panic
disorder) or reduced interoception (e.g., dissociative disorder).
It has also been suggested that atypical interoception may be
associated with vulnerability to psychopathology (17).
In MiCBT, interoceptive awareness and equanimity are
achieved through a process of systematic exposure to body
sensations using a sequence of body scanning exercises to
practice and cultivate equanimity toward body sensations. Since
habitual reactivity is a common factor shared by numerous
mental health conditions (21), treatments which address these
underlying processes are likely to have transdiagnostic effects.
As MiCBT places great emphasis on increasing interoceptive
awareness and desensitization, it is expected to improve emotion
regulation across a range of emotional disorders, including those
with complex comorbidities. MiCBT is designed for acute and
chronic mental health conditions.
The rationale for MiCBT, described in detail in the protocol
paper for the current study (22,23) and elsewhere (1012)
is based on the co-emergence model of reinforcement (10,
24) which is explicitly taught during the intervention [see
(22,23)Figure 1, p. 3]. The model proposes that following a
sensory stimulus (either from external sources through sight,
smell, touch, taste, or hearing or from internal sources through
thinking, remembering or interoception) an evaluative process
takes place. Sensory events that are deemed to be personally
relevant result in spontaneous co-emerging interoception, which
directs behavior. According to the co-emergence model, behavior
is moderated by the quality and strength of co-emerging
interoceptive experience (body sensations), where unpleasant
body sensations are more likely to be the antecedents of
avoidant behavior, while pleasant sensations are more likely
to generate seeking behaviors. This is consistent with Barrett’s
theory of emotion which proposes that the tendency to react is
proportional to the strength of affect (25), and thus emotions
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Francis et al. MiCBT Reduces Depression and Anxiety
are not considered to be reactions to the world but dynamic
constructions of it (26).
MiCBT integrates meditation skills adopted from the
Vipassana (insight) tradition taught by U Ba Khin and Satya
Narayan Goenka (10). Accordingly, MiCBT provides a structured
sequence of practices: (1) body awareness through progressive
muscle relaxation and attention to posture and movement in
daily activity, followed by (2) mindfulness of breath to increase
attention regulation, metacognitive awareness and response
inhibition, (3) body-scanning methods to develop deep levels
of interoceptive awareness and equanimity (body-scanning
methods comprise 75% of the meditations in MiCBT), and (4)
loving kindness meditation to increase empathy and compassion
for self and others.
MiCBT Involves four stages. Stage 1 mostly consists
of learning the above meditation skills to self-regulate. In
stages 2 and 3, the exposure methods implemented include
graded imaginal and in vivo exposure to increase tolerance
of interoceptive signals while reducing reactivity to avoided
situations and conflictual interpersonal situations. In the fourth
stage, to assist in preventing relapse, exposure is applied to
potential harmful behaviors which patients learn to prevent out of
compassion for themselves and others. According to the MiCBT
rationale, reducing reactivity assists with improved general
functioning, including social functioning and connectedness
with others, thus enhancing wellbeing and flourishing (27,28),
which in turn helps prevent relapse (28).
Evidence for the efficacy of MiCBT is building across different
conditions, including depression, anxiety and depression in
individuals with multiple sclerosis (29,30), anxiety and
depression during pregnancy (31), sports anxiety (32), pain
and pain self-efficacy in patients with breast cancer (33),
and chronic pain in the general population (34). In a very
recent study, post-partum depression was demonstrated to be
ameliorated in a group who received MiCBT and changes
were detected at a chromosomal level (35). An uncontrolled
unpublished pilot study of group MiCBT for patients with mixed
diagnoses conducted in a private psychology practice setting
(n=69) demonstrated significant reductions in psychological
distress across disorders (36). However, to our knowledge,
the application of MiCBT as a group intervention in a
transdiagnostic psychiatric population has not been subject to
controlled investigation.
The aim of the current study was to investigate the
effectiveness of MiCBT as a transdiagnostic group-based
therapy to decrease psychological distress for patients with
a range of mild to severe mental health disorders in a
primary health care setting in real world conditions. The
hypotheses were that, compared to the control group, the
MiCBT group would show a greater decrease in self-report
assessments of depression, anxiety and stress, and greater
improvement in life satisfaction and flourishing. It was also
hypothesized that the improvements would be maintained over
a 6-month follow-up period. Additionally, it was hypothesized
that improvements in the clinical measures as a function of
MiCBT relative to the control group would be mediated by
(a) improvements in metacognitive and interoceptive awareness,
and (b) improvement in equanimity. We also hypothesized
that changes in life satisfaction and flourishing scores would
be mediated more by improvements in interpersonal skills
compared to awareness and equanimity.
METHODS
Participants were randomized to either the MiCBT or the
treatment-as-usual (TAU) control condition. Participants on
both conditions continued with treatment-as-usual including
medications and/or psychological therapy. The MiCBT
intervention was offered to control group participants following
the completion of the 6-month follow-up assessment. This study
was granted ethical approval by the Monash University Human
Research Ethics Committee (Project Number: CF16/2278-
2016001131). All participants provided written informed
consent prior to their inclusion in the study.
Recruitment
Information about the study was circulated to local medical and
psychology clinics and rolling recruitment took place over 2
years through referrals from local general medical practitioners,
psychiatrists, and psychologists. Inclusion criteria were: age
18–75; fluent in English; and with a Kessler Psychological
Distress Scale-10 (K10) score of 20 or more. Exclusion
criteria included: <18 years; non-English speakers; current
psychotic symptoms, current drug or alcohol dependency,
current diagnosis of borderline or antisocial personality disorder,
pervasive developmental delay, organic mental disorder, or
prescribed more than 20 mg diazepam equivalent per day.
Patients who were referred to the study were interviewed
to confirm eligibility and to gain written consent. A total
of 206 patients expressed interest in the study and were
assessed. Of the 80 participants excluded from the study,
6 did not meet criteria and 74 declined to participate
(see Figure 1).
Sample Size
The trial is powered to detect significant differences relevant
to the primary outcome. A power analysis (G-power 3.1) for
medium effect (Cohen’s d=0.5) was conducted with power
of 0.8, and using the conventional significance level (0.05),
resulting in a desired sample of 102 (51 participants in each
group). Consistent with previous studies [e.g., (37)] allowing
for a conservatively estimated attrition rate of 20% to follow
up, we aimed to recruit a sample of 120. Based on the
projected sample size of 102, power of 0.8, and zero, small,
medium or large effect sizes conditions for the indirect effect,
the mediation analyses are well-powered to detect medium
beta paths between the independent variable (IV) and the
mediator and between the mediator and the dependent variable
(DV) (β=0.39) using bootstrapping and the Sobel test
(38). Data were collected using online self-report measures
with the Qualtrics platform at the four measurement points:
baseline, mid-intervention, post-intervention, and 6-months
follow-up.
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Francis et al. MiCBT Reduces Depression and Anxiety
FIGURE 1 | CONSORT flow diagram. *One participant provided data at post and follow up only.
Randomization
Participants were assigned a unique identification number and
allocated to either the control or the MiCBT group. Blocked
randomization was conducted using Stata (version 14SE) by
means of alternating treatment group allocation based on
blocks to yield treatment groups with balanced proportions of
participants from respective blocks. A sequence of treatments
(treatment or control) was created randomly permuted in blocks
of size 4. Blocks of size 4 were chosen to ensure a balance of
treatments in all group sessions, as groups of size 8 could begin
as soon as 16 participants were recruited.
Randomization was also stratified based on three stratification
variables, each having two values: K10 score (20–29, mild to
moderate; 30, severe); psychotropic medication (yes/no) and
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Francis et al. MiCBT Reduces Depression and Anxiety
gender (female/male). Therefore, a randomization schedule was
generated for each of the 8 strata (2 ×2×2):
F N 20+
F N 30+
F Y 20+
F Y 30+
M N 20+
M N 30+
M Y 20+
M Y 30+
Stata Version 14 SE generated the randomized schedules for this
study with 2 arms and with a sample size of 400, a block size of 4,
or 100 blocks of 4. Randomization was conducted by a researcher
who was independent from the recruitment, assessment and
treatment of participants.
Participants
In total, 125 participants provided signed informed consent and
were randomized to a treatment group (one participant was
mistakenly allocated two identification numbers). However, 7
participants were lost to the study before contributing any data
leaving 118 participants. Of these, 86 identified as female (72.9%),
31 as male (26.3%), and one as “other” (0.8%); the age range
was 20–72 years. As per inclusion criteria, all participants had
a K10 score of 20 on referral and this was administered
again at the start of the study. Demographic and baseline clinical
characteristics are shown in Table 1.
Participants were typically well educated, 87% having tertiary
education. In both groups 70% were taking some form of
psychotropic medication; 30% had some meditation experience
and/or currently had some meditation practice.
Participant Timeline
Referring General Medical Practitioners administered an initial
K10 as part of the referral process. Participants were interviewed
for eligibility and those who were eligible were randomized to
either the control or MiCBT condition. Baseline assessments
were administered post-randomization, 1 week before the
commencement of the program so that the assessment timeframe
could be standardized across participants and to address the
significant variation in the period between recruitment and the
start of the intervention. This was expected to achieve maximum
sensitivity to change taking account of fluctuating mental health
conditions. The flow of participants through the study is outlined
in Figure 1.
Measures
All outcome and process measures listed below are
psychometrically acceptable self-report questionnaires and
are described more fully in the protocol paper (22,23). Both the
K10 and the DASS-21 were used in the current study to measure
psychological distress. The DASS-21 however provides both a
global measure (total score) and measures of depression, anxiety
and stress as separate subscales. The DASS-21 scores were the
primary focus of the analysis.
TABLE 1 | Participant characteristics.
Variable MiCBT group Control group
Gender: n(%)
Male 15 (24.6) 16 (28.1)
Female 46 (75.4) 40 (70.2)
Other 1 (1.8)
Age: n(%)
18–34 21 (34.4) 18 (31.6)
35–49 15 (24.6) 24 (42.1)
50–75 25 (41.0) 15 (26.3)
Nationality: n(%)
Born in Australia 49 (80.3) 47 (82.5)
Born outside Australia 12 (19.7) 10 (17.5)
Marital status: n(%)
Married/in a relationship 25 (55.7) 32 (56.1)
Single/divorced/separated 34 (41) 23 (40.4)
Other 2 (3.3) 2 (3.5)
Education: n(%)
High school education only 12 (19.7) 4 (7)
Post high school education 49 (80.3) 53 (93)
Taking Psychotropic medications n(%) 26 (70) 35 (66.7)
Pre-trial meditation practice n(%) 18 (30) 19 (33.3)
K10 score at referral: mean (SD) 29.4 (6.1) 29.3 (5.6)
K10 score T0 27.7 (7.0) 29.0 (6.3)
K10 score at referral n(%)
<30 (mild-moderate) 30 (49.2) 30 (52.6)
30 (severe) 31 (50.8) 27 (47.4)
K10 score T0 n(%)
<30 (mild-moderate) 38 (62.3) 28 (49)
30 (severe) 23 (37.7) 29 (51)
Primary Outcome Measure
Depression, Anxiety, and Stress Scale (DASS-21)
The DASS-21 is a 21-item self-report questionnaire designed
to measure three domains: depression, anxiety and stress
experienced in the previous week (39). Each subscale contains
7 items, and items are rated on a four-point Likert scale. The
DASS-21 is reported to have high internal consistency for each
of the subscales (Cronbach’s alpha: depression, α=0.88; anxiety,
α=0.82; stress, α=0.90; total scale α=0.93), alongside
evidence of good convergent and discriminant validity (40).
Factor analysis supports the use of the total score as a measure
of general psychological distress (40). The DASS-21 total score
was used as the primary outcome while also reporting findings
for the three subscales. In accordance with the manual (41) the
scores on the DASS-21 were doubled to convert them to the
full scale DASS scores and enable interpretation using the norms
for the DASS-42. The manual provides recommended cutoffs for
conventional severity labels derived from z score conversions
from the normative sample (normal, mild, moderate, severe,
or extreme range) (41). Higher scores indicate more severe
symptoms relative to the population.
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Francis et al. MiCBT Reduces Depression and Anxiety
Secondary Outcome Measures
Kessler Psychological Distress Scale (K10)
The K10 is a 10-question screening scale of psychological
distress that focuses on emotional problems experienced in
the last 4 weeks and is shown to discriminate severity of
psychological distress between clinically significant disorders as
defined in the DSM-IV and non-clinically significant disorders.
Several Australian studies using national survey data support the
psychometric properties of the K10 including its validity as a
measure of distress and as screen for mental health disorders,
particularly anxiety and depressive conditions (1,42,43). This
measure was chosen because it is commonly used by General
Practitioners in Australia as a screening tool to identify those
eligible for subsidized psychological treatment.
Satisfaction With Life Scale (SWLS)
This is a 5-item self-report measure of global judgment of life
satisfaction (41). The SWLS uses a 7-point Likert scale from 1
(strongly disagree) to 7 (strongly agree). The range of possible
scores is from minimal satisfaction with life (5) to very high
satisfaction with life. Higher scores indicate higher levels of
life satisfaction. The SWLS has been shown to have convergent
validity with other self-report measures of life satisfaction,
including the Philadelphia Geriatric Center Morale Scale. The
SWLS appears to tap a single life satisfaction factor. Internal
consistency is good with Cronbach’s alpha of α=0.87.
The Flourishing Scale (FS)
The FS is an 8-item self-report measure of psychological
wellbeing, designed to tap self-perception of aspects of wellbeing
such as optimism, positive relationships and self-esteem (44).
It uses a 7-point Likert scale with responses from strong
disagreement to strong agreement. Scores range from 8 to 56
and high scores indicate positive self-appraisal of psychological
wellbeing. The scale developers report strong correlations
with other psychological wellbeing scales and good internal
consistency with Cronbach’s alpha of α=0.87.
Process Measures
Process measures were chosen to best reflect the aspects of
mindfulness which are the focus of MiCBT.
Multi-Dimensional Assessment of Interoceptive Awareness
(MAIA)
The MAIA is a 32-item self-report measure of interoceptive
awareness (45). The MAIA has eight subscales, all reflecting
different aspects of interoception; Noticing, Not-Distracting,
Not-Worrying, Attention Regulation, Emotional Awareness,
Self-Regulation, Body Awareness, Trusting (45). We therefore
decided to use total MAIA scores in the current study. Higher
scores indicate higher levels of interoceptive awareness. The
internal-consistency reliability of each of the eight subscales was
reported by the scale developers as ranging from α=0.66 to 0.87.
The Non-attachment Scale (NAS)
The NAS is a 30-item self-report scale. It is a unidimensional
measure of attachment as the term is used in Buddhism tapping
the construct of being equanimous, flexible and receptive (46). It
uses a 6-point Likert scale ranging from 1 (disagree strongly) to
6 (agree strongly). Higher scores indicate higher levels of non-
attachment. The NAS is shown to correlate with a quality of
consciousness related to constructs such as emotion regulation,
interpersonal effectiveness, wellbeing and mental health. Internal
consistency levels are >α=0.80 (Cronbach’s alpha).
The Experiences Questionnaire (EQ)
This is a 20-item self-report measure of decentering; the ability
to observe thoughts and feelings with objectivity rather than
identifying with experiences (47). Higher scores indicate higher
levels of decentering. Metacognitive awareness is a key element
of decentering, conceptualized as a protective factor assisting
with resilience to depressive relapse (4850). For the purposes
of this paper, metacognitive awareness and decentering are used
interchangeably. The EQ is a relatively new measure whose
psychometric properties are still being investigated. The initial
psychometric evaluation of the EQ supported its concurrent
and divergent validity with significant positive correlations
reported with a measure of cognitive reappraisal and significant
negative correlations with brooding rumination, experiential
avoidance, emotional suppression, and depressive and anxiety
symptoms (47). In a later Spanish study, the EQ scale was
found to have good internal consistency (Cronbachs alpha α
=0.89) and ability to differentiate between psychiatric and
non-psychiatric patients. Convergent validity was evidenced by
significant correlations with the Mindfulness Attention and
Awareness Scale (MAAS) (r>0.58), and the Five Factor
Mindfulness Questionnaire (FFMQ) (r>0.46) while divergent
validity was evidenced by significant negative correlations with
measures of anxiety, depression, stress and experiential avoidance
(r<0.35) (51).
Mindfulness-Based Self-Efficacy Scale-Revised (MSES-R)
The MSES is a 22-item self-report measure designed to assess the
changes in levels of perceived self-efficacy due to mindfulness-
based therapy (52). Higher scores indicate higher levels of
mindfulness-based self-efficacy. The six subscales were separated
into two clusters for the purposes of the current study; Emotion
Regulation, Distress Tolerance, Equanimity (considered here
as measuring aspects of equanimity; MSES-R-E), and Taking
Responsibility, Social Skills, and Interpersonal effectiveness
(considered here as measuring aspects of interpersonal skills;
MSES-R-S). The MSES-R total shows high internal consistency
(Cronbach’s alpha α=0.86); has a good divergent validity, inverse
relationships with the DASS-21, and good concurrent validity
with the Freiberg Mindfulness Inventory (FMI), the MAAS, the
Kentucky Inventory of Mindfulness (KIMS), and the FFMQ. A
recent study (52) reported high reliability using McDonald’s ω
(ω=0.87).
Other Measures
Meditation Practice
Participants recorded daily meditation practice by recording the
number of minutes per practice session and the number of
practice sessions per week on a prescribed form in their program
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Francis et al. MiCBT Reduces Depression and Anxiety
notes. The weekly total was collected by the researcher at each
session on an individual form not visible to other participants.
Adverse Effects
Each week participants were asked about their practice so that
any issues raised could be addressed. In a few instances minor
modifications to practice were recommended such as continuing
with an exercise a little longer before moving to the next exercise.
At 6-month follow-up, questions were included regarding any
adverse experiences believed to be due to meditating. We took
these questions from a recent study of experiences that occur in
association with meditation practices (53). The questions were:
1. “Did you have any unexpected, challenging, or difficult
experiences that you associate with your practice
of meditation?”
2. “How did these experiences impact your life”?
Procedure
All participants completed the outcome and process measures 1
week before the start of the MiCBT group intervention (T0), after
week 4 (T1), at week 8 (T2, post-intervention), and then again
after a 6-month follow up period (T3). Demographic questions
were included at T0, program evaluation questions at T2, and
at T3. There were questions about meditation practice in the
last 6 months as well as about any adverse effects. Measures
were administered online using Qualtrics survey software, except
for the amount of meditation practice, which was recorded by
participants as described above. Participants were emailed a
link to the online measures utilizing their unique identification
number. All data was collected online (except meditation
practice hours).
Intervention Groups
The intervention protocol (22,23) was adapted from the
published protocols (10,11) and consisted of 8 weekly 2 h classes.
Adaptations from the original 8-week protocol included: (a)
using the most recent publicly available audio instructions from
Cayoun (11) (used with permission) and (b) individual sessions
between groups were not routinely offered. In accordance with
the protocol, a guided meditation was conducted at each session
to introduce the practice required for the following week. The
remainder of the time in the sessions was used for a review
and discussion about practice experiences and psychoeducation,
including the rationale for practices and homework tasks.
Recommended weekly homework tasks included two half-hour
meditation sessions per day (7 h per week). Inter vention group
sizes varied between 8 and 13 participants. The intervention was
delivered by a registered psychologist trained in MiCBT who
had been implementing MiCBT regularly over the past 10 years.
Handouts for each session were provided as a workbook at the
start of treatment. The handouts included practice record sheets,
worksheets, and a list of homework tasks. The treatment outline
is depicted in Table 2.
Control group participants received treatment as usual during
the 8-week intervention period and until the end of the 6-month
follow up at which time the MiCBT intervention was offered (32
participants took up the offer). Treatment as usual for mental
TABLE 2 | Four stages of the MiCBT 8-week program.
1. Personal
stage (weeks 1,
2 and 3)
2. Exposure
stage (weeks 4
and 5)
3. Interpersonal
stage (week 6)
4. Empathic stage
(weeks 7 and 8)
Progressive
muscle
relaxation and
attention to
body posture
Mindfulness of
breath
(attending to
breath)
Body scanning
(Burmese
Vipassana
tradition)
Co-emergence
model of
reinforcement
Advanced
body scanning
Overcoming
avoidance
Integrating
mindfulness
and CBT
exposure tasks
to address
avoidance
Advanced
body scanning
Moving from
focus on self to
others;
exposure to
interpersonal
difficulties
Mindful
assertiveness
Taking
responsibility
for own
experience in
interpersonal
situations;
exposure tasks
for
interpersonal
avoidance
More advanced
and flowing body
scanning
Empathy and
compassion with
loving kindness
meditation
Non-attachment
to sense of self
Ethics—
minimizing harm
to self and others
health conditions in Australian primary care is largely delivered
through medical General Practitioners including assessment,
treatment planning, direct treatment (such as medication and
initial focused psychological strategies) and referral to specialist
private services including psychiatry, psychology and other allied
health services. Australian Medicare, designed as a universal
health insurance scheme, provides Australian residents with
rebates to help cover the cost of medical services from
private health providers, including General Practitioners and
specialist providers, based on scheduled items of care (the
Medicare Benefits Schedule). Co-payments from patients are
unrestricted and practitioners are free to choose their practice
location. Standard treatment in primary care is regulated by
National Standards (54) adherence to which is upheld by
regular accreditation.
Statistical Analyses
Main Analyses
We used mixed-model repeated measures to account for
the correlations between repeated measurements within each
participant. Stata version 16 was used to test the effect of
MiCBT on each outcome measure using a mixed effects restricted
maximum likelihood (REML) regression for each outcome
variable with participants included as random effects intercepts
and group and time as fixed effects.
An important advantage of the mixed model over repeated
measures ANOVA is that the modeling of the individual
participant variables can accommodate multiple missing data
points in longitudinal datasets (55). All available data were
therefore included in the analysis and, in line with the intention-
to-treat approach, regardless of compliance with the treatment
protocol (56). Although mixed-effects REML is robust to missing
data (55), a sensitivity analysis was also conducted by imputing
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Francis et al. MiCBT Reduces Depression and Anxiety
missing data for the primary outcome (DASS-21) using multiple-
imputation by chained equations (MICE) (57).
Mediation Analyses
An overview of the two planned mediation models is described
in Francis et al. (22,23). The first planned model comprised:
group (MiCBT vs. TAU-wait-list control) as the IV; clinical and
wellbeing measures as the DVs; and awareness (metacognitive
and interoceptive) and equanimity measures that revealed
significant group x time interactions as mediators. It was
intended to test changes occurring both during the program
and during the follow-up phase. The second planned model
comprised: group as the IV; T3 psychological wellbeing as
the DV; and T2 social functioning, awareness and equanimity
measures that revealed significant group x time interactions
as mediators.
Data were analyzed using the Statistical Package for Social
Sciences (SPSS) Version 26.0 software (58). An alpha level of
.05 was set for the main inferential tests. All mediation analyses
were conducted using the PROCESS macro version 3.5 for SPSS;
unstandardized regression coefficients are reported (59). Path
coefficients were computed in PROCESS for: path a, the effect of
the IV on the mediator; path b, the effect of the mediator on the
DV controlling for the IV; path c, the total effect of the IV on the
DV; and path c, the direct effect of the IV on the DV controlling
for the mediator. Point estimates of each indirect effect (ab) and
percentile bootstrapped confidence intervals were computed by
averaging the ab product from 5,000 random samples of the
original data. Indirect effects are significant if the lower and upper
boundaries of the bootstrapped 95% confidence intervals (CIs) do
not include zero. Figure 2 displays the a, b, c, cand ab paths.
Following correlation analysis of the model variables using
Pearson’s correlation coefficients, model building commenced
with a series of single mediation models to identify relevant
mediators for the final model (60,61). To take into account
changes over time, baseline (pre-intervention period) measures
of the outcome and mediator (“lags”) were included in the
modeling as covariates in preference to difference scores, as
recommended by Hayes (59) and Valente and MacKinnon (62).
Similar to Gu et al. (63), analyses for the two planned multiple
mediation models used standardized residualized change scores
for mediator and outcome variables calculated using linear
regression in which baseline scores predicted post-intervention
scores for mediators and baseline scores predicted follow-up
scores for the outcome variable.
Exploratory Analysis: Clinically Significant Change
An exploratory analysis of clinically significant change was
conducted for the DASS-21 using descriptive, chi-square and
odds ratio (OR) statistics and based on an adaptation of the
Ronk et al. classification system (64) for indicating recovery
(deteriorated, improved, recovered). We used the following
categories to define clinical significance: normal range; mild-
moderate range (collapsing mild and moderate together) and
severe-extreme range (collapsing severe and extreme categories
together). We defined deteriorated as unimproved; making no
clinically significant positive change; (i.e., did not move to a less
severe category). Improved was defined as moved to a less severe
range and recovered was defined as moved to normal range.
RESULTS
Data from 118 out of the 125 participants were analyzed (MiCBT
group =61; Control group =57) because 7 participants were lost
to the study prior to commencement. The MiCBT and control
groups were compared at time points: pre- (T0), mid- (T1), post-
(T2), and at 6-month follow-up (T3). Missing data sets (entire
data set) across timepoints were: T0 =8; T1 =12; T2 =24; T3 =
22. There were 8 incomplete data sets (respondent fatigue). The
missing data pattern was non-monotone. Preliminary analysis
using binary logistic regression indicated that missing data for
the primary outcome variable, the DASS-21, across the four data
collection points was not associated with age, gender, education,
baseline K10 and medication. We therefore assumed the data was
missing at random.
There were no significant differences in K10 change scores
from referral to baseline between the control group (M= 0.28,
SD =5.58) and MiCBT group [M= 2.00, SD =5.64; t(116)
=1.66, p=0.10, two-tailed]. Although more participants in
the MiCBT group reported a reduction in K10 symptoms in
the waiting period before the program commenced the mean
difference =1.72 (95% CI: 0.33 to 3.77) was small (eta
squared =0.02).
The mean number of meditation practice hours across the 8-
week program was 27.25 (13.70) median =30 h; range =0–49.
The mean weekly practice hours were 4.47 h. The mean number
of classes attended was 6.22 (1.87); median 7.0; range =1–8. The
dropout rate from data collection at the final assessment point
for the MiCBT and control groups respectively was 22% (14/64)
and 25% (15/61), respectively. Excluding participants who were
lost to the study before completing the baseline assessment,
the dropout rate from MiCBT treatment, defined as insufficient
treatment (<4 sessions), was 23.0% (14/61). Information about
medications at 6-month follow up was collected from the MiCBT
group and 82% (37/45) reported no change to their medications
while 4 participants lowered or ceased medications; 3 changed
medications (no details provided) and 1 participant increased the
medication dose.
In relation to adverse effects, 19 (31%) of the MiCBT
participants responded “yes” to the question, “Did you have
any unexpected, challenging or difficult experiences that you
associate with your practice of meditation?” Of these, 12
participants provided a description of their experience in
response to the question, “How did these experiences impact your
life” (see Table 3 for descriptions).
Main Analysis
Supplementary Table 1 presents the means, standard deviations,
and medians of all measurement instruments at the four time
points for each group. Supplementary Table 2 presents the
means, standard deviations, and medians of the three subscales
of the DASS-21. Table 4 and Supplementary Table 3 presents the
intervention differences estimated by the regression model for
the effects of time (i.e., model adjusted intervention difference)
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Francis et al. MiCBT Reduces Depression and Anxiety
FIGURE 2 | Path diagram depicting parallel mediation model 1, testing whether changes in equanimity (MSES-R-E) and awareness (EQ) mediate the effects of MiCBT
vs. control on improvements in the DASS-21. Unstandardized path coefficients are displayed. * <0.05; *** <0.001. EQ, Experiences Questionnaire; MSES-R-E,
Mindfulness-based Self-Efficacy Scale-Revised-Equanimity subscales; DASS-21, Depression, Anxiety, and Stress Scale-21. a, b, cand c are unstandardized
regression coefficient (with standard errors) which represent predicting the mediator from group (a), DASS-21 change form M controlling for group (b), DASS-21
change from group controlling for both mediators (direct effect, c), and DASS-21 change from group not controlling for the mediators (total effect, c). The product of a
and b paths, ab, represents the mediated or indirect effect. Change refers to standardized residualized changed scores.
for the outcome and mediator measures, respectively, and
Table 5 presents the effect sizes. Timepoints T1–T3 are all
compared to baseline T0. Intervention status is MiCBT compared
to control. Results showed that all outcome and mediation
measures showed significant improvement over time compared
to baseline.
The primary outcome measure (DASS-21) demonstrated
significant differences between the MiCBT and the control
groups (p<0.0001) as did the K10 and the FS. Only the
SWLS failed to reach significance (p=0.177). The differences
between the MiCBT and control groups adjusting for the effects
of time were as follows: DASS-21 9.17 (95% CI: 12.33 to
6.01); K10 3.54 (95% CI: 4.62 to 2.47); SWLS 0.59
(95% CI: 0.27 to 1.45); FS 2.17 (95% CI: 1.03 to 3.30). All
mediation measures demonstrated significance (p<0.0001). The
differences between the MiCBT and control groups adjusting
for the effects of time were as follows: MSES-R-E (Equanimity)
3.80 (95% CI: 2.71 to 4.88); MSES-R-S (Interpersonal skills) 1.79
(95% CI: 1.07 to 2.51); MAIA 12.23 (95% CI: 10.09 to 14.38);
NAS 11.47 (95% CI: 8.73 to 14.21); EQ 3.83 (95% CI: 2.95
to 4.71).
The results of sensitivity analysis for the DASS-21 using
MICE to impute the missing data remained significant
with the coefficients changing only marginally (see
Supplementary Table 4).
Because all the measures at baseline were similar in both
groups (Supplementary Table 1), and improved at each time
point following baseline, the intervention status results provide
evidence that MiCBT improved participant outcomes on the
DASS-21, K10, and FS compared to controls along with all
mediation measures.
Mediation Analyses
Correlations between model variables are shown in
Supplementary Tables 5, 6. T0 correlations were substantially
lower than at T3 and therefore the strength of correlation
changed as a function of the intervention. Because all mediators
showed significant group ×time interactions in the main
analyses, we constrained the number of analyses by limiting the
DV to the primary outcome (rather than including both the
DASS-21 and the K10), and the time frame to the follow-up
(rather than both the follow-up and treatment period). Focusing
on mediators measured at the end of treatment affecting outcome
measured at 6-month follow-up enabled the examination of
mechanisms related to the full effects of treatment and their
sustainability over time, which we considered to be of most
interest. This timeframe allowed for changes in the mediator
during the treatment phase to be measured prior to the change
in outcome.
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Francis et al. MiCBT Reduces Depression and Anxiety
TABLE 3 | Unexpected challenging or difficult effects associated with meditation.
Responses that described effects that may be considered
adverse (n=12)
1. They caused mood swings and changed the way some of my
relationships progressed.
2. I needed to rest a lot.
3. Limited time to practice.
4. Not to such a great extent but I can become irritable.
5. Some positive, some negative.
6. Hard to explain but affected my anxiety.
7. Made me want to avoid meditating.
8. In the beginning there were extremely intense sensations that were
really, really distracting, particularly at work. I spent my first week
constantly feeling as though I would have a panic attack, along with
intense pain throughout my body. I had to remind myself it was just
part of the process. With a difficult first week and a few moments
of intense memories throughout body scanning, the results were
incredible. I never anticipated to feel “at peace”, or “content” in my
life... I think that’s getting closer to happiness? Relationships in my life
have improved dramatically, and the ruminating over this person and
that person, this situation or that, wasn’t an issue—it’s like a happy
oblivion, but still aware of all the craziness.
9. They brought unprocessed trauma closer to the surface.
10. The body scanning brought up some issues that I had placed on
emotional lockdown and I went through a period of intense healing
and rest after doing the course.
11. For the first 2 weeks meditation felt great, around 4–6 weeks I
noticed that I was becoming more aware of challenging emotions in
my body, that were perhaps previously ignored.
12. Some PTSD triggers.
The single mediation analyses included four independent
variable mediation models (MAIA, EQ, NAS, MSES-R-E) to
assess symptom change in the DASS-21 as a function of
MiCBT vs. control during the timeframe of the follow-up
period (mediators measured at post-intervention; outcomes at
6 months) and five independent variable mediation models
(MAIA, EQ, NAS, MSES-R-E, MSES-R-S) assessing change
in the FS as a function of treatment condition during the
same timeframe. The MAIA, EQ, NAS, and MSES-E were
each significant mediators between treatment and outcome as
measured by DASS-21 (see Supplementary Table 7). In addition,
the MAIA, EQ, NAS and MSES-E, and MSES-S were significant
mediators between intervention and outcome as assessed by FS
(see Supplementary Table 8).
Model 1
Awareness (interoceptive awareness measured by the MAIA
and metacognitive awareness measured by EQ) and equanimity
(measured by the MSES-R-E and NAS) are the core focus in
MiCBT, which are developed independently and simultaneously
(65). The relative influence of awareness and equanimity on
outcomes was examined in the first (parallel) multiple mediation
model. Given theoretical overlap and large correlations between
the mediators (r=0.45–0.85) one candidate variable was selected
from each construct based on having the strongest correlation
with the DASS-21 at time 3 (see Supplementary Table 6). These
were MSES-R-E and EQ. Results are shown in Figure 2. While
65.3% of the total effect of MiCBT relative to control on the
TABLE 4 | Mixed REML regression models for outcome variables with fixed
factors of time and intervention status, and participants as random.
DASS-21 bse z p-value 95%Conf. Interval
Timepoint
T1 7.46 2.13 3.51 0.000 11.62 3.29
T2 12.08 2.54 4.75 0.000 17.06 7.09
T3 10.38 2.17 4.78 0.000 14.63 6.13
Intervention status
19.17 1.61 5.69 0.000 12.33 6.01
Number of obs =413, Number of groups =118, Bootstrap replications =50,
Log restricted-likelihood = 1,791.41, Wald chi2(4) =73.89, Prob >chi2=0.00.
K10 bse z p-value 95%Conf. Interval
Timepoint
T1 3.60 0.78 4.63 0.000 5.13 2.08
T2 4.42 0.80 5.51 0.000 6.00 2.85
T3 4.79 0.86 5.57 0.000 6.48 3.11
Intervention status
13.54 0.55 6.48 0.000 4.62 2.47
Number of obs =405, Number of groups =118, Bootstrap replications =50,
Log restricted-likelihood = 1,307.54, Wald chi2(4) =97.97, Prob >chi2=0.00
SWLS bse z p-value 95%Conf. Interval
Timepoint
T1 2.12 0.60 3.50 0.000 0.93 3.30
T2 2.96 0.57 5.22 0.000 1.85 4.07
T3 3.08 0.53 5.78 0.000 2.03 4.12
Intervention status
1 0.59 0.44 1.35 0.177 0.27 1.45
Number of obs =411, Number of groups =118, Bootstrap replications =50,
Log restricted-likelihood = 1,245.15, Wald chi2(4) =47.31, Prob >chi2=0.00.
FS bse z p-value 95%Conf. Interval
Timepoint
T1 2.86 0.63 4.52 0.000 1.62 4.10
T2 3.84 0.74 5.17 0.000 2.39 5.30
T3 4.26 0.75 5.70 0.000 2.79 5.72
Intervention status
1 2.17 0.58 3.74 0.000 1.03 3.30
Number of obs =411, Number of groups =118, Bootstrap replications =50,
Log restricted-likelihood = 1,333.32, Wald chi2(4) =73.53, Prob >chi2=0.00.
DASS-21, Depression, Anxiety, and Stress Scale-21; K10, Kessler Psychological Distress
Scale; SWLS, Satisfaction with Life Scale; FS, Flourishing Scale.
DASS-21 at time 3 was due to the indirect effect of MSES-
R-E measured at time 2, only 10.8% of total effect was due
to the indirect effect of EQ at time 2. While only MSES-R-E
had a significant indirect effect on the DASS-21 at time 3, the
difference between the two indirect effects was not significant. See
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Francis et al. MiCBT Reduces Depression and Anxiety
TABLE 5 | Means and effect sizes from mixed REML regression models for outcome and mediator variables.
Model calculated (95% CI) Estimated
Cohen’s d
Control Intervention Difference
Outcome variables
DASS-21 47.12 (44.97, 49.27) 37.95 (35.82, 40.08) 9.17 (12.33, 6.01) 0.38
K10 27.19 (26.43, 27.95) 23.65 (22.96, 24.34) 3.54 (4.62, 2.47) 0.45
SWLS 18.95 (18.36, 19.54) 19.55 (18.98, 20.11) 0.59 (0.27, 1.45) 0.08
FS 37.35 (36.52, 38.18) 39.51 (38.78, 40.24) 2.17 (1.03, 3.30) 0.24
Mediator variables
MAIA 62.38 (61.02, 63.73) 74.61 (72.81, 76.40) 12.23 (10.09, 14.38) 0.67
NAS 108.41 (106.62, 110.22) 119.89 (117.70, 122.07) 11.47 (8.73, 14.21) 0.48
EQ (decentering) 30.10 (29.57, 30.64) 33.93 (33.24, 34.62) 3.83 (2.95, 4.71) 0.16
MSES-R-E (Equanimity) 26.29 (25.67, 26.92) 30.09 (29.21, 30.97) 3.80 (2.71, 4.88) 0.50
MSES-R-S (Interpersonal) 22.28 (21.78, 22.77) 24.07 (23.56, 24.58) 1.79 (1.07, 2.51) 0.34
DASS-21, Depression, Anxiety, and Stress Scale-21; K10, Kessler Psychological Distress Scale; SWLS, Satisfaction with Life Scale; FS, Flourishing Scale; MAIA, Multi-dimensional
Assessment of Interoceptive Awareness; NAS, Non-attachment Scale; EQ, Experiences Questionnaire; MSES-R-E, Mindfulness-based Self-Efficacy Scale-Revised-Equanimity
subscales; MSES-R-S, Mindfulness-based Self-Efficacy Scale-Revised-Interpersonal skills subscales.
Supplementary Table 9 for the PROCESS macro version 3.5 for
SPSS output for model 1.
Model 2
In a second parallel model (Supplementary Figure 1), we
examined whether the effect of MiCBT vs. control on flourishing
scale scores are mediated more by improvements in interpersonal
skills compared to awareness and equanimity. While the total
indirect effect of EQ, MSES-R-E and MSES-R-S was significant,
B=0.43 (0.15) 95% CI (0.19 to 0.75), and accounted for 64.8% of
the total effect of Group on FS at time 3, none of the individual
mediators when combined had a significant indirect effect. See
Supplementary Table 10 for the PROCESS macro version 3.5 for
SPSS output for model 2.
Exploratory Analysis: Clinically Significant
Change
In the control group, 40.5% (17/42) of participants were
unimproved based on DASS-21 scores and 21.4% (9/42) were
recovered at follow up. Participants in the MiCBT group showed
significantly greater clinical improvement compared to controls
with just 16.7% (8/48) unimproved and 41.7% (20/48) recovering.
Overall, at 6-month follow-up 83.3% (40/48) of participants in
the MiCBT group showed improvement or recovery compared to
59.5% (25/42) of participants in the control group. Chi-square for
group differences was 6.3, df =1, p=0.01 (n=90). Individuals
in the MiCBT group had higher odds of a successful treatment
(OR: 3.4, 95% CI: 1.3 to 9.0; p=0.01) and their relative risk for
deterioration was 0.4 (95% CI: 0.2 to 0.9).
In the MiCBT group, 74% of participants who improved or
recovered did at least 20 h of meditation practice (i.e., 2.5 h
per week) while 26% improved or recovered with <20 h. Fifty-
two percent of those who recovered or improved attended all 8
sessions and 94% of improved/recovered group attended at least
5 sessions.
Further exploratory analysis of the data from those who
had severe levels of distress at T0 suggests that the MiCBT
intervention was effective for severe anxiety with 77% recovered
or improved (13/17) compared to 33% (4/12) recovered or
improved in the control group. For those with severe levels of
stress at T0, 81% recovered or improved (13/19) compared to
40% (6/15) in the control group. MiCBT was no better than usual
treatment in the severely depressed group (50%5/10 improved
or recovered) compared to 57% (8/14) of the control group.
DISCUSSION
In the present study we investigated the effectiveness of MiCBT
as a transdiagnostic intervention delivered in a naturalistic
primary health care setting. The findings support our hypotheses
that MiCBT would (a) reduce levels of depression, anxiety
and stress as measured by the total DASS-21 scores and
(b) improve flourishing significantly more than TAU, and (c)
that such differential improvements would be sustained over
a 6-month follow-up period. The findings did not, however,
support our hypothesis of improved life satisfaction—although
scores trended toward improvement, the change did not
reach significance.
Results of parallel mediation models suggested that
equanimity was the most important change variable for
symptom reduction and interpersonal skills did not show a
significant mediation effect for flourishing when compared
to awareness (decentering) and equanimity. That equanimity
was the most important change variable is consistent with the
theoretical framework provided by the co-emergence model of
reinforcement (24). Specifically, the acquisition of equanimity is
facilitated by scanning the body systematically in detail without
reacting to perceived body sensations.
The range of severity of clinical symptoms (mild to severe)
was reflective of presentations in primary health care in Australia
where a K10 score >20 is frequently used to initiate treatment
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Francis et al. MiCBT Reduces Depression and Anxiety
referral. The rate of adherence to the MiCBT treatment is
consistent with other studies [e.g., (66,67)] with 77% (47/61) of
participants receiving four or more sessions. The mean practice
hours was less than the recommended 7 h per week (64% of
recommended). This is consistent with a study of practice time
in a Mindfulness-based Cognitive therapy (MBCT) program (68)
which reported that participants who were asked to practice
6 days out of seven in fact practiced on average on 3.36
days (56% of recommended) per week. In the current study,
adherence to standard program delivery was supported using
audio instructions that provide both a rationale for each exercise,
and guidance for each meditation type. In this way participants
have some of the CBT elements of the rationale reinforced.
A strength of the current study is that data about so-
called adverse effects was actively collected. The data indicated
that 19 participants (31%) responded “yes” to the question
on “unexpected, challenging, or difficult experiences that you
associate with your practice of meditation”. However, only 12
participants provided any detailed descriptive responses. Six
of the twelve descriptions were vague (Table 3 responses 2–
7); one response described mood changes and four reported
that past trauma was triggered. One response while describing
initially difficult experiences went on to describe very positive
results “With a difficult first week and a few moments of
intense memories throughout body scanning, the results were
incredible. . . (Table 3 response 8). In MiCBT, trainees are
explicitly forewarned that both pleasant and unpleasant body
sensations are to be expected during practice, and that they are
to remain equanimous to whatever arises.
Different frequencies of adverse effects from meditation in
a mindfulness-based intervention (MBI) have been reported
dependent on methodological approach ranging from 3.7
to 33.2% (60). Furthermore, it is recognized that in the
Buddhist Vipassana tradition there are stages of development
of insight or knowledge, some of which involve negative
experiences such as fear, sense of dissolution, disgust, which
may result in potential clinical effects (69). Challenges in
MiCBT are to be expected because the therapeutic strategy
is fundamentally exposure based: by developing equanimity
toward sensations, a desensitization process takes place, enabling
tolerance of previously intolerable experience. For many
people the experience of physical pain and psychological
distress is deemed intolerable, and pharmaceutical pain-relieving
interventions are sought. Consequently, instruction to sit with
discomfort non-reactively may be very challenging for some
people, especially when the level of equanimity is not yet well
developed. Interestingly, a recent study demonstrated that there
was no relationship between the occurrence of an emotional
experience early in a mindfulness intervention and adverse
outcomes or drop-out rate (70). In some instances, participants
clearly understood that any difficulties were a natural part of
the process, and that the development of equanimity enabled a
transformation of attitude to difficulties (e.g., Table 3, response
8). Data on unexpected or unpleasant effects was only collected
at follow-up which may be a limitation of the study. While most
of those who discontinued the program provided reasons such as
changed personal circumstances, it is possible that some people
dropped out due to unpleasant effects. The dropout rate was
consistent with other studies which reported between 14 and 25%
drop out rates (71).
Results indicate significant positive change across most
measures both clinical and non-clinical after only 4 weeks of the
program. There was further symptom reduction at week 8 and
at follow up the changes were mostly maintained or enhanced.
That the pattern of change was consistent across all measures
is of interest because the interpersonal skills are not explicitly
taught until the second half of the program. It appears that the
elements of stage 1 of the intervention generalized across both
clinical and non-clinical measures. These results may indicate
the importance of the co-emergence model of reinforcement
in providing a sound cognitive rationale for engaging in the
meditation elements, body scanning in particular. The co-
emergence model is used as a psycho-education tool to assist
participants to understand the relationship between evaluative
thinking and co-arising body sensations. Using the model may
be instrumental in motivating participants to complete the daily
meditation tasks.
Limitations and Future Research
This study has several limitations. Firstly, the lack of an
active control precludes being able to distinguish between
improvements that may be due to generic group processes as
opposed to the MiCBT skill acquisition. However, the findings
from the mediation analysis provide some evidence that the
effects of MiCBT operated through its hypothesized mechanisms,
especially equanimity. Nonetheless, to build the evidence for
the specific effects of MiCBT, future research could test the
comparative effectiveness of MiCBT against an active control
such as CBT, MBCT or other third wave therapies.
Secondly, the sample was not representative of the general
Australian population. Specifically, there was low representation
of participants born outside Australia (12%) compared to 30%
in the general population and our sample was also more
highly educated than the general population with over 80% of
participants with post-school education compared to 56% for
the general population (72). It is possible that the population
willing to engage in meditation-based therapies tend to be
more educated as there is some requirement for homework and
effortful meditations.
Thirdly, while we collected information on medications, we
did not collect data on any other therapeutic interventions
that participants may have been offered. Also, although we
asked MiCBT group participants at follow up if there had
been any changes to medications, we did not collect this data
from the control group. Future studies might investigate the
possibility of reductions of medication needs in patients whose
depression, anxiety and stress scores improve following the
MiCBT intervention.
Fourthly, the same therapist (the first author) conducted
all the group training limiting generalizability. Future research
could replicate the study with different facilitators including,
potentially, at different skill levels as this has implications for
treatment dissemination (73). The use of the most recent audio
instructions recorded by the developer of the program (BC)
Frontiers in Psychiatry | www.frontiersin.org 12 May 2022 | Volume 13 | Article 815170
Francis et al. MiCBT Reduces Depression and Anxiety
would support consistency in delivery, as mentioned earlier.
The current study also used the 8-week protocol (10) that was
available at the start of the study. The protocol has since been
extended to a 10-week protocol (11) and future studies might
investigate results with the more recent protocol.
Fifthly, the baseline measures for the study were administered
post-randomization, 1 week prior to the start of the program.
While this had the advantage of accounting for the delay in
recruitment for some groups to maximize sensitivity to change
in the context of fluctuating mental health conditions, it also
had the potential to produce a systematic observer or participant
bias. However, we consider this to be unlikely. Observer bias is
unlikely because the main measures were administered online.
Participant bias is still possible but perhaps minimal because
there were no significant group differences between the (pre-
randomization) medical practitioner administered K10 and the
(post-randomization) baseline K10 that would suggest, for
example, demoralization in the control group. A disadvantage
was that seven participants were lost to the study post-
randomization while awaiting the start date. All participants were
aware from the commencement of the study that they would be
offered MiCBT within a reasonable time frame.
Sixthly, the exploratory analysis examining clinically
significant change applied the severity cut-off scores from the
DASS manual. These were included by the manual’s authors
to help characterize the severity of symptoms relative to the
population. On the manual website, http://www2.psy.unsw.
edu.au/dass//DASSFAQ.htm#_5._ it is noted that emotional
syndromes such as anxiety are dimensional, and the use of
cut-offs are necessarily arbitrary and should not be reified.
However, as we are assessing change pre- and post-treatment in
an Australian sample, these cut-offs provide a potentially useful
indication of clinical effects since these cut-off scores are widely
used clinically in this country.
A final limitation of the study to note is that it was designed
using K10 scores as inclusion criteria rather than diagnosis which
would have better supported the transdiagnostic applicability
of MiCBT.
Notwithstanding these limitations, the present results add
to previous research supporting to the effectiveness of the
MiCBT group-based intervention. The use of a randomized
controlled trial in a naturalistic private psychology clinic setting
with a heterogenous population is a contribution to this
under-researched area. The collection of data at the mid-
point as well as at 8 weeks and 6-month follow up provides
useful information about timelines for change. Importantly,
the results support the transdiagnostic applicability of MiCBT,
demonstrating significant improvements in clinical outcomes in
the first 4 weeks of treatment, increasing in the second half
of the program and being maintained over a 6-month period
across a population with a range of disorders and levels of
distress severity. It is noteworthy that significant gains were
apparent after just 4 weeks despite the amount of meditation
practice undertaken by participants being less than prescribed.
Future studies could explore what may be minimum practice
requirements while still achieving clinical improvements and
whether the gains at 4 weeks can be maintained even without
receiving the remaining 4 weeks of the program or whether the
second half of the program is essential for long-term change.
DATA AVAILABILITY STATEMENT
The dataset generated for this study can be found in the
research repository of Monash University: https://www.
monash.edu/library/researchers/researchdata/bridges: DOI:
10.26180/13240304.
ETHICS STATEMENT
This study involving human participants was reviewed and
approved by Monash University Human Research Ethics
Committee (Project Number: CF16/2278 - 2016001131).
The participants provided their written informed consent to
participate in this study.
AUTHOR CONTRIBUTIONS
SF conducted the research and led the writing of this paper as part
of a PhD thesis. FS was the primary supervisor and GM and BC
were co-supervisors. JE and FS devised and guided the statistical
analyses. FS, GM, and BC contributed to the writing, editing, and
critical revision of the intellectual content of the manuscript. All
authors approved the final version of this manuscript.
ACKNOWLEDGMENTS
This project was undertaken through Monash University. We
thank Shrinkhala Dawadi for assistance with the data analyses.
We thank our project participants who, in sharing their time and
experience, made this study possible.
SUPPLEMENTARY MATERIAL
The Supplementary Material for this article can be found
online at: https://www.frontiersin.org/articles/10.3389/fpsyt.
2022.815170/full#supplementary-material
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Conflict of Interest: BC and SF have been paid for developing and delivering
educational presentations, workshops and professional training programs for the
MiCBT Institute in Australia and North America. BC and SF receive royalties
for the text: The Clinical Handbook of Mindfulness-integrated Cognitive Behavior
Therapy: A Step-by-step Guide for Therapists.
The remaining authors declare that the research was conducted in the absence of
any commercial or financial relationships that could be construed as a potential
conflict of interest.
Publisher’s Note: All claims expressed in this article are solely those of the authors
and do not necessarily represent those of their affiliated organizations, or those of
the publisher, the editors and the reviewers. Any product that may be evaluated in
this article, or claim that may be made by its manufacturer, is not guaranteed or
endorsed by the publisher.
Copyright © 2022 Francis, Shawyer, Cayoun, Enticott and Meadows. This is an
open-access article distributed under the terms of the Creative Commons Attribution
License (CC BY). The use, distribution or reproduction in other forums is permitted,
provided the original author(s) and the copyright owner(s) are credited and that the
original publication in this journal is cited, in accordance with accepted academic
practice. No use, distribution or reproduction is permitted which does not comply
with these terms.
Frontiers in Psychiatry | www.frontiersin.org 15 May 2022 | Volume 13 | Article 815170
... There is evidence to suggest that in clinical practice equanimity holds an important role in the benefits of mindfulness (Francis et al., 2022) and is a promising target for clinical outcome measures (Desbordes et al., 2015). Equanimity is proposed to occur through the separation of desire and avoidance, from their corresponding hedonic tone of an interoceptive experience, whether unpleasant, pleasant, or neutral (Hadash et al., 2016). ...
... Our second hypothesis, that the clinical group would score higher on the ES-16 and its subscales than the control group at post-treatment, was also supported. This is understandable since MiCBT specifically teaches equanimity skills, and those who have undergone this intervention typically show higher levels of equanimity Francis et al., 2022). This suggests that the ES-16 provided an accurate assessment of key skills taught during the intervention. ...
... This effect was not observed in the general population sample. By the same token, these results support previous findings showing the transdiagnostic effectiveness of MiCBT in clinical practice (e.g., Francis et al., 2022). This has been attributed to the ability to neutralize the reinforcement of conditioned reactions through applying equanimity toward the feeling tone co-emerging with unhelpful cognition, both in sitting meditation and in daily life across disorders . ...
Article
Full-text available
The predictive validity of the Equanimity Scale-16 (ES-16) has not yet been examined, despite its suggested utility in measuring reduced reactivity and increased experiential acceptance following a mindfulness-based intervention (MBI). In this study, we examined the predictive validity of the ES-16 in a heterogeneous clinical group who underwent a 10-session mindfulness-integrated cognitive behavior therapy (MiCBT) and a general population (control) group. As the advantage of accounting for response shifts in MBIs has been demonstrated but not evaluated on equanimity scales, this study also investigates potential response shifts on the ES-16. A heterogeneous clinical group (n = 52; 46.2% males, 53.9% females; age 19–67) with one or more mental health conditions undertaking a mindfulness-based intervention (MiCBT) and a control group (n = 67; 43.3% males, 56.7% females, age 18–67) were recruited from the general population via social network platforms. All completed measures of equanimity, depression, anxiety, stress, and five facets of mindfulness at pre-treatment and post-treatment, and pre-treatment ratings were re-scored retrospectively after treatment in order to assess response-shift effects in both clinical and control samples. As predicted, the clinical group scored the ES-16 significantly lower than the control group at pre-treatment (p < 0.001) and significantly higher than the control group at post-treatment (p < 0.001). A significant interaction between Group and Time was found on all measures (p < 0.001). Follow-up pairwise comparisons detected response-shift effects on all measures in the clinical group, but not in the control group. The ES-16 was sensitive to improvements from pre- to post-intervention in the clinical group and discriminated clearly between participants with one or more mental health conditions from those in the general population, both at pre- and post-treatment, showing good predictive validity. Response shift was detected on all measures in the clinical group, suggesting that pre-/post-assessment may underestimate the effectiveness of MiCBT, and possibly other MBIs. Results support both the use of the ES-16 in clinical contexts and the utility of retrospective scores to detect and quantify response shift as a measure of increased experiential awareness following an MBI. This study is not pre-registered.
... Finally, social forms of mindfulness, such as group and dyadic meditation, may further leverage the OE to enhance motivation and outcomes by fostering community and support, improving adherence and depth (135,136). Dyadic mindfulness enriches this through mutual feedback and shared experiences (137), amplifying mindfulness' therapeutic benefits by integrating social elements into the practice. ...